Category Archives: Ohio Stem Cells

I get sent stuff by patients all the time. This week a patient reached out about Riverside Biologic Healths IV and injection at home umbilical cord stem cell service. Hence, lets dig in.

I received two unsolicited emails from a patient describing himself as an advocate for Regenexx:

High Tina, please pass on my request to dr. Centeno about the back ground of Riverside biologics, and also the director Dr. Neil Riodan. I attended one of their sales meetings and listened to some fantastic claims of which most were lies. One item of interest I did not understand was that the DNA becomes inactive when the cells are extracted from the fetus because of the HLA protein so there is no possibility of rejection. I tried to research this but did not get a clear understanding. All the other claims were of course the Wild West. The marketing was interesting in that in my state on rep would send post cards in each city or town inviting people to come to the meetings for healing.

Good morning doc, I remember you mentioning this outfit in one of your blogs but I would like to know more about dr. Neil Riodan and the macenna institute. I attended one of their marketing meetings in ohio and it was the wild west of stem cells. The speaker claimed that riodan had 40 patents and 70 publishings to back up all of his claims. I wont bore you with all the claims, you have heard them before, but he made one remark about no possibility of rejection using foreign live cells because of the HLA protein. I did not know what he was talking about and tried to research it and did not find anything to explain it. I will add that the procedures range from $4000 to $14000 administered in your home by a PA. At the end of the meeting I confronted the speaker about all the stuff I learned from you and he said Regenexx is a bully. Is there any truth about the HLA protein?

Thats a good question. On the website, they claim to offer both Regenerative Cell Therapy and be a Leader in Joint Pain Therapy. Their website is pretty nebulous, but lets start with this coverage map:

That word choice is interesting. Notice how instead of saying that the company has affiliates, offices, or clinics in these states, it uses the term coverage. In fact, you cant find out anything about what this coverage entails. However, a familiar name does pop up here on their website: Scott Gray, DC.

Ive blogged on Scott Gray, DC before. He is/was the CEO of Stem Cell One and Gray Marketing Enterprises. What is Stem Cell One? Another chiropractic clinic that has billed itself as Leading Umbilical Stem Cell Therapy in Marion, Ohio! Scott also owns a company called Gray Marketing Enterprises, and he used to state on his LinkedIn page, Dr Gray also published a book helping chiropractors help more patients; The Ultimate New Patient Machine. That profile, after being discussed in a prior blog has now been deleted.

Ive also blogged before on Biologics Health, a company associated with Scott Gray. When you Google Biologics Health now and Scotts name, Riverside Biologics Health comes up, so I have to assume that Scott added the word Riverside to this company.

Last year when I reviewed Scotts at-home umbilical cord stem cell service called Biologics Health, it was pretty much the same business now being described by this patient. A nurse would come to your home to give you an IV of umbilical cord stem cells. It also looks like that same nurse will perform a joint injection, but perhaps thats performed in a clinic? This was all very concerning at that time, as any such procedure should be performed in a room that looks like this:

And not like this:

Another problem was that the research back then and since, given our new paper published in the American Journal of Sports Medicine and those papers published by others, showed that commercially available umbilical cord preparations had no living stem cells (1-4). It looks like since the FDA crackdown Scott has scrubbed this new website of the phrase stem cells, but based on the patients communication above, thats still central terminology used in their seminars. Frankly, its amazing that the FDA has yet to stop this one, as IMHO I can think of few things that sound more innocuous, but in my opinion, are more dangerous than an IV umbilical cord infusion. Lets dig into that topic.

First, as discussed above, none of these umbilical cord products sold in the US have any live and functional mesenchymal stem cells. The research in this area has made that clear time and time again. However, a few of these products do have live and dying cells which are foreign tissue. When umbilical cord blood treatments are used in pediatric cancer cases, these are HLA matched to the patient (5-7). Why? The patients immune system will reject the cells, however, there will be less rejection if the cell surface markers on the umbilical cord cells are a close match to the patients own markers. However, I have yet to see a company using this stuff that matches the patient to the product.

What can happen when mismatched umbilical cord cells are injected into a body? A severe rejection reaction known as Graft vs. Host Disease (GVHD) (7). GVHD can be mild with rashes and feeling sick or it can be severe with organ failure. I know this one personally, as Im the medical expert on several legal cases where umbilical cord tissue injections were given in chiropractic and medical offices, and in my medical opinion, caused GVHD. In one case, a poor elderly man went into renal failure.

How about the salespersons statement above? This what the patient relayed was said:

One item of interest I did not understand was that the DNA becomes inactive when the cells are extracted from the fetus because of the HLA protein so there is no possibility of rejection.

Is this scientifically accurate? Nope. If you have live cells that are dying, the tissue will be read as a foreign invader by the patient and an immune response will be mounted. Now if the manufacturer made a conscious effort to kill all of the cells, that could help. However, the handout given out at the seminar by Riverside Biologics Health website says:

That certainly sounds like Riverside is claiming live cells. The rest of the brochure talks about how stem cell numbers decline with age (not actually accurate in the way portrayed, see this blog for more information).

Who gave this medical advice? Scott Boyer, a guy with a 4-year communications degree and Dale Carnegie sales training. Based on his Linkedin profile, Scott is a professional salesperson experienced in giving sales presentations and NOT a medical or scientific expert.

One of the bait and switch tactics used by these stem cell outfits is that they post research that has nothing to do with the product theyre offering to lend a veneer of credibility to their sales pitch. Riverside Biologics Health does that as well. Not a single paper listed has anything to do with the off-the-shelf umbilical cord tissue product theyre using. Even nuttier, they have listed one of my earliest research papers on using culture-expanded bone marrow stem cells in a knee, which again has nothing to do with dying umbilical cord tissue in a bottle.

Its clear from the patient that Neil Riordans product is being used in this venture. This is a product that I have blogged on called Signature Cord where the manufacture has claimed that it contains live and functional mesenchymal stem cells. Again, despite this past claim, there is no credible scientific data that this umbilical cord product contains any live and functional MSCs.

I know Neil. He has a Ph.D. and is a Physicians Assistant. He has published a slew of things about his live stem cell product being used at his clinic in Panama but has yet to publish any randomized controlled trial on those treatments. In addition, I know of no studies at all on the US product called Signature Cord, which is whats being used here. Hence, in my opinion, this is more bait and switch on the part of Riverside.

Given that Scotts Linkedin profile was deleted, I decided to see if I could find a corporate HQ for either Biologics Health or Riverside Biologics Health. That led me to a corporate registration agent in St. Pete, Florida, but no offices could be found. IMHO, thats par for the course here, as Riverside is a sales company run by a chiropractor whose career has focused on increasing the revenue of chiro practices. Meaning that Riverside is not a biotechnology venture nor is it a chain of clinics staffed by physician specialists.

The website states, the products of conception (amniotic fluid, umbilical cord, placenta, and accompanying materials) are discarded. In this case, its donated by the mother, with no harm to the baby. The materials are transferred immediately via a sterile container to a nearby FDA certified lab.Is there such a thing? Nope. The FDA doesnt certify labs that process birth tissues. You can register your lab via a free registration system (Tissue Establishment Registration), but that only tells them where to go if they want to inspect you. That doesnt mean they have certified or approved your lab.

One of the reasons that there has been a name change, adding the word Riverside to Biologics Health may be that the company received a letter from the FDA. This letter states exactly what I have reviewed, that Riverside Biologics Health is violating federal law by delivering umbilical cord IV treatments to patients. Has that stopped the company? Apparently not as they have given seminars after that date.

The upshot? At the end of the day, IMHO, sending nurses to homes to inject umbilical cord tissue is not Kosher. I hope the FDA continues to act on this one.

______________________________________

References:

(1) Berger D, Lyons N, Steinmetz, N. In Vitro Evaluation of Injectable, Placental Tissue-Derived Products for Interventional Orthopedics. Interventional Orthopedics Foundation Annual Meeting. Denver, 2015. https://interventionalorthopedics.org/wp-content/uploads/2017/08/AmnioProducts-Poster.pdf

(2) Becktell L, Matuska A, Hon S, Delco M, Cole B, Fortier L. Proteomic analysis and cell viability of nine amnion-derived biologics. Orthopedic Research Society Annual Meeting, New Orleans, 2018. https://app.box.com/s/vcx7uw17gupg9ki06i57lno1tbjmzwaf

(3) Panero, A, Hirahara, A., Andersen, W, Rothenberg J, Fierro, F. Are Amniotic Fluid Products Stem Cell Therapies? A Study of Amniotic Fluid Preparations for Mesenchymal Stem Cells With Bone Marrow Comparison. The American Journal of Sports Medicine, 2019 47(5), 12301235. https://doi.org/10.1177/0363546519829034

(4) Berger DR, Centeno CJ, Kisiday JD, McIlwraith CW, Steinmetz NJ. Colony Forming Potential and Protein Composition of Commercial Umbilical Cord Allograft Products in Comparison With Autologous Orthobiologics. Am J Sports Med. 2021 Oct;49(12):3404-3413. doi: 10.1177/03635465211031275. Epub 2021 Aug 16. PMID: 34398643.

(5) Eapen, Mary et al. Mismatched Related and Unrelated Donors for Allogeneic Hematopoietic Cell Transplantation for Adults with Hematologic Malignancies. Biology of Blood and Marrow Transplantation, Volume 20, Issue 10, 1485 1492. https://www.ncbi.nlm.nih.gov/pubmed/24862638

(6) Flomenberg N, Baxter-Lowe LA, Confer D, et al. Impact of HLA class I and class II high-resolution matching on outcomes of unrelated donor bone marrow transplantation: HLA-C mismatching is associated with a strong adverse effect on transplantation outcome. Blood. 2004;104(7):19231930. https://www.ncbi.nlm.nih.gov/pubmed/15191952

(7) Holtan SG, Pasquini M, Weisdorf DJ. Acute graft-versus-host disease: a bench-to-bedside update. Blood Jul 2014, 124 (3) 363-373; DOI: 10.1182/blood-2014-01-514786

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NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. All content provided in this blog, website, or any linked materials, including text, graphics, images, patient profiles, outcomes, and information, are not intended and should not be considered or used as a substitute for medical advice, diagnosis, or treatment. Please always consult with a professional and certified healthcare provider to discuss if a treatment is right for you.

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Riverside Biologics Health Review: At Home "Stem Cells ...

Bailey Johnson 21 has a gift for being where she needs to be to meet her goals.

Starting in August 2022, that will be Tsinghua University in Beijing, China. There shell join the newest class of Schwarzman Scholars, pursuing a masters degree in global affairs. Johnson is among 151 scholars in nearly three dozen countries, chosen from more than 3,000 applicants worldwide for the all-expenses-covered graduate leadership program.

Schwarzman Scholars are high-caliber individuals with open minds and limitless potential who will serve to deepen understanding between China and the rest of the world, according to the groups website.

Johnson fits the bill. Shes already working as a cancer researcher for the National Institutes of Health, chiefly focused on understanding metastatic traits that allow tumor cells to colonize secondary organs. She also is a fellow at the NIH Academy on Health Disparities, studying gaps in health outcomes and addressing related issues.

Classes for Schwarzman Scholars are taught in English, but Johnson brings the advantage of fluency in Mandarin a language she started learning as a child in Columbus, Ohio. She refined those skills at Mary Washington, where she double-majored in biology and a self-designed course of Chinese cultural studies.

At UMW she was seemingly indefatigable, joining the Student Government Association, the African Student Union and the Asian Student Association. She was also a resident assistant for four years, competed in track and field as a first-year student and volunteered for Habitat for Humanity building homes in Florida. In addition, she founded a STEM mentoring program for children in underserved communities.

Johnson intentionally sought out Mary Washington peers with international backgrounds for one-on-one conversations. Their cultural experiences, unlike my own, helped me see global issues through a different lens and the need for this understanding to make a real difference, she said.

She formed lasting friendships with several students: Olayemi Fadahunsi 21, who shared her knowledge of Nigeria; Chase Forster 21, who is a Fulbright recipient teaching English in Bulgaria; and Burundian native Nehemia Abel 20, who is a Payne graduate fellow at Georgetown University.

Most notably, Johnson worked with the Center for International Education (CIE) to complete a semester in Xian, China, where courses included intensive language studies and traditional Chinese medicine.

Johnson worked with UMWs Center for International Education to pursue a semester abroad in China, where her studies included intensive language courses and traditional Chinese medicine.

Johnson (right) with University of Antwerp students Sonia Debock and Ali Durrani. The trio took a language class together at Northwest University in Xian, China.

A double major in biology and a self-designed Chinese cultural studies track at UMW, Johnson spent a semester abroad in China. Next summer, shell return to pursue her graduate degree in global affairs.

My time there solidified my goal to turn my life experiences, language education, and sciences and health background into something more global, ultimately merging health, politics, economics and culture, Johnson recalled.

Mary Washington professors helped her develop her interests in the sciences, in politics and policy, in international relations and in clear, professional writing. They provided advocacy and extra tough love, she said.

Among them are Associate Professor of Chemistry Leanna Giancarlo, CIE director and Associate Professor of Spanish Jose Sainz and Professor of Political Science and International Affairs Elizabeth Freund Larus. Professor of Spanish Betsy Lewis and Adjunct Instructor of Chinese Pei-ni Causarano also helped. Plus, Johnson described Assistant Professor of Biology Josephine Antwi as a great teacher, mentor and advisor for my research project.

The admiration is mutual. Several UMW professors reacted to this weeks announcement of Johnsons award with little surprise.

She is a wonderful person and was a great student. So glad for her, Lewis said. Professor of Biology Deborah ODell echoed that sentiment: She exemplifies the qualities that we hold dear at UMW.

Johnsons goal? My future work will include shaping a research agenda between China and the United States, she said, stimulating the generation, translation and dissemination of valuable knowledge.

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China-bound Graduate Focused on Global Goals - University of Mary Washington

Webinar to be held on Thursday, December 16, 2021, at 2:30 p.m. ET

WORCESTER, Mass., Dec. 09, 2021 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (Mustang) (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating todays medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced that it will host a key opinion leader (KOL) webinar on MB-106, the Companys CD20-targeted, autologous CAR T cell therapy for the treatment of B-cell non-Hodgkin lymphomas (B-NHLs) and chronic lymphocytic leukemia (CLL), on Thursday, December 16, 2021, at 2:30 p.m. Eastern Time.

The webinar will feature a presentation by Mazyar Shadman, M.D., M.P.H., Associate Professor at the Fred Hutchinson Cancer Research Center (Fred Hutch) and a physician at Seattle Cancer Care Alliance, who will discuss updated interim results from the ongoing Phase 1/2 clinical trial investigating the safety and efficacy of MB-106 for patients with relapsed or refractory B-NHLs and CLL. These data were selected for presentation at the the 63rd American Society of Hematology Annual Meeting (ASH2021), which is being held December 11-14, 2021. Dr. Shadman, along with colleague Brian Till, M.D., also an Associate Professor at Fred Hutch and physician at Seattle Cancer Care Alliance, will be available to answer questions following the formal presentations.

Mustang Bios management team will provide additional details on the planned MB-106 Phase 1/2 clinical trial to be conducted under Mustangs Investigational New Drug (IND) application. The U.S. Food and Drug Administration accepted Mustangs IND to initiate a multicenter Phase 1/2 clinical trial investigating the safety, tolerability and efficacy of MB-106 for relapsed or refractory B-NHLs and CLL.

To register for the event, please click here.

About Dr. ShadmanMazyar Shadman, M.D., M.P.H., is an Associate Professor at the University of Washington (UW) and Fred Hutch as well as a physician at Seattle Cancer Care Alliance. He is a hematologic malignancies expert who specializes in treating patients with lymphoma and CLL.

Story continues

Dr. Shadman is involved in clinical trials using novel therapeutic agents, immunotherapy (CAR T cells), and stem cell transplant for treatment of lymphoid malignancies with a focus on CLL. He also studies the clinical outcomes of patients using institutional and collaborative retrospective cohort studies.

Dr. Shadman received his M.D. from Tehran University in Iran. He finished an internal medicine internship and residency training at the Cleveland Clinic in Cleveland, Ohio. He completed his fellowship training in hematology and medical oncology at UW and Fred Hutch. Dr. Shadman also earned an M.P.H. degree from UW and was a fellow for the National Cancer Institutes cancer research training program at Fred Hutch, where he studied cancer epidemiology.

About Dr. TillBrian Till, M.D., is an Associate Professor in the Clinical Research Division of Fred Hutch and Department of Medicine at UW as well as a physician at Seattle Cancer Care Alliance. His laboratory focuses on developing chimeric antigen receptor (CAR)-based immunotherapies for non-Hodgkin lymphoma and understanding why CAR T cell therapies work for some patients but not for others. He led the first published clinical trial testing CAR T cells as a treatment for lymphoma patients. Dr. Till also has a clinical practice treating patients with lymphoma and attends on the stem cell transplantation and immunotherapy services at the Seattle Cancer Care Alliance.

Note: Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.

About MB-106 (CD20-targeted CAR T Cell Therapy) CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustangs research collaborator, Fred Hutch, in the laboratories of the late Oliver Press, M.D., Ph.D., and Brian Till, M.D., Associate Professor in the Clinical Research Division, and exclusively licensed to Mustang in 2017. MB-106 has been optimized as a third-generation CAR derived from a fully human antibody and is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in patients with B-NHLs and CLL. Additional information on the trial can be found at http://www.clinicaltrials.gov using the identifier NCT03277729.

About Mustang BioMustang Bio, Inc. is a clinical-stage biopharmaceutical company focused on translating todays medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with top medical institutions to advance the development of CAR-T therapies across multiple cancers, as well as lentiviral gene therapies for severe combined immunodeficiency. Mustang is registered under the Securities Exchange Act of 1934, as amended, and files periodic reports with the U.S. Securities and Exchange Commission (SEC). Mustang was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit http://www.mustangbio.com.

ForwardLooking StatementsThis press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on managements current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Company Contacts:Jaclyn Jaffe and Bill BegienMustang Bio, Inc.(781) 652-4500ir@mustangbio.com

Investor Relations Contact:Daniel FerryLifeSci Advisors, LLC(617) 430-7576daniel@lifesciadvisors.com

Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com

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Mustang Bio to Host Key Opinion Leader Webinar on MB-106, a Potential Treatment for B-Cell Non Hodgkin Lymphomas and Chronic Lymphocytic Leukemia -...

On planet Earth, we face the challenge of feeding a rapidly growing population that is set to reach 9.7 billion people by 2050. In space, we face the challenge of feeding astronauts traveling through the galaxy for an extended period of time. Novel and innovative food technology could offer viable solutions in both realms.

For the first time ever, NASA and CSA (Canadian Space Agency) have come together this year to host the Deep Space Food Challenge. Companies competing in the challenge must be able to offer a solution to feeding at least four astronauts on a three-year space mission. The solutions should be able to achieve the greatest amount of food output (that is palatable and nutritious) with minimal input and waste. In addition to being used in space, the solution must also improve food accessibility on Earth.

This week, the winners of Phase 1 were announced:

MANUFACTURED FOODS

BIO CULTURE FOODS

PLANT GROWTH

Many companies that were selected as Phase 1 winners use technologies that have steadily gained popularity in the food tech space, like 3D printing, using bioreactors for cultured protein, and vertical farming. In-demand future food ingredients like fungi, microbes, cultured cells/meat, and insects were also popular amongst competitors.

Out of the 28 winners, here are some of our favorites:

Beehex (Columbus, Ohio) Some of you may remember Beehex for their work on a 3D pizza printer for NASA. For this competition, Beehex is proposing a UFF (Universal Food Fabricator) which can dehydrate plants and cultured meats into powder form foods, store them into hermetically sealed cartridges for 5+ years, and 3D print with the stored food in cartridges when needed.

Deep Space Entomoculture (Somerville, Massachusetts) In this companys proposed food system, dry-preserved insect cells will be brought up into space. Using a suspension bioreactor, the insect cells, along with other ingredients, will be reactivated and used to create traditional meat-like analogs.

Space Bread (Hawthorne, Florida) As the name aptly suggests, this companys tech allows for crew members to create bread in space. This food system includes a multifuntional plastic bag that is used to store and combine ingredients, and then bake a roll.

Mission Space Food: This company is making a system that will cultivate meat in space using pluripotent stem cells using cell cryopreservation and bioreactor. The creators say the system can can grow beef as well as be adapted to grow other meats such as pork or lamb.

AMBAR (Bucaramanga, Colombia) Operating as a small-scale ecosystem, AMBARs growing cabinet contains different compartments for various plants. Within this system, both terrestrial and aquatic are able to be grown for food.

Hefvin (Bethesda, Maryland) This company produces berries by growing fruit cells in a nutrient rich media. Spherification (the culinary process used to shape liquid into squishy spheres) is used to encase different cells to create a full berry, complete with skin and pulp.

Space Cow: (Germany) this company makes a system converts CO2 and waste streams straight into food, with the help of a food grade micro-organisms and 3D printing.

Each U.S. winner of Phase 1 has been awarded $25,000 to continue working on their solution and is invited to continue on to the Phase 2 competition.

Related

Continue reading here:
Fruit Cells, Space Bread, and Cultured Meat Cartridges: Deep Space Food Challenge Announces Phase 1 Winners - The Spoon

Originally, the word foray meant an invasion or raid, usually with the goal of plundering. More recently, its come to mean exploring an unfamiliar subject or activity. But for mushroom enthusiasts, the word has special meaning. A foray is any time they get together and learn about their favorite fungi, as 20 or so people did at Scenic Vista Park, south of Lisbon, Ohio, July 11.

As he has for the past 20 years, Walt Sturgeon, of East Palestine, brought samples and answers to questions to the parks pavilion. Having researched and written books about them for the past 45 years, hes become a nationally known expert on mushrooms.

Sharon Parrish, of Salem, said she had a lot of mushrooms growing near the many oak trees in her backyard. Squirrels eat them, and she was worried that her dog would, too. She picked the mushrooms to try to keep them from spreading, but that didnt work, she said.

Youre picking an apple from a tree, Sturgeon said metaphorically. Youre not destroying the organism.

He explained that the mycelium, the network of fungus that produces mushrooms, is like a giant spider web that seems to go on forever, unseen because each strand is only as wide as a single cell. More than 8 miles of these cells can be found in a cubic inch of soil.

These networks are mostly underground, but they can also grow on dead wood, tree roots and other surfaces. If the mycelium has enough to eat and the weather is right, it will make mushrooms, which are the fruit of the fungus.

The mushroom is just the tip of the iceberg, Sturgeon told his audience. Picking it just removes the fruit, not the mycelium fibers that can live for years, even decades.

Having grown up on a farm south of Alliance, Ila Oyster wondered if pasture mushrooms are good to eat, and what, exactly, are puffballs?

Ive eaten mushrooms all my life, said Oyster, who now lives with her husband, Ken, in Kensington. They were always a treat for me.

Sturgeon remembers eating pink-bottom mushrooms, which he called a second cousin to the store-bought varieties, that he picked from the pasture as a kid. But not all mushrooms that grow in pastures are edible, he said, so its important to identify them first.

Puffballs are mushrooms that contain millions of spores. Theyre edible when theyre white, but if dark green or purple, they will burst at the slightest touch and send spores all over. He compared puffball flesh to tofu and recommends cooking it in garlic butter or frying it with bacon.

Another participant wanted to know about the mushrooms that look like big fans and grow on trees. Sturgeon said those are called artist conk and make great material for painting and etching. They can span a foot or more and grow bigger each year, making rings like trees.

But these mushrooms are even more dense than the wood they grow on, and are only edible for beavers, he said. Mushrooms have symbiotic relationships with trees, he said, especially those that have needles or nuts.

In northeast Ohio, beech and oak trees are likely to have mushrooms growing with them, as well as birch, aspen, willow and cottonwood.

The tree provides carbohydrates that the fungus uses for food. The mushrooms break down material and provide minerals and nutrients to the trees. Sturgeon said. Its a give-and-take process. Without mushrooms, we wouldnt have healthy trees.

Mushrooms are a good food source for insects, snails and turtles as well as some mammals, like squirrels and deer.

Theyre all tied together, he said. Mushrooms are a critical part of the food chain.

Oddly enough, theres no scientific definition for mushrooms; theyre just macrofungi, as opposed to mini fungi, like yeast. More than 2,000 species of mushrooms have been documented in Ohio, but Sturgeon thinks the real number is closer to 3,000. Many types of mushrooms have not been studied or given names yet, he said.

That seems to be one of the goals of new groups of mushroom enthusiasts, who call mycelium the wood wide web. Hot mushroom topics online include mycoremediation, looking into fungi as a way to clean up toxic waste and other environmental problems, and radical mycology, investigating its ability to help the environment and human beings, as in medicine.

Both new and old fans of the fungi agree that identifying mushrooms before eating them is crucial. Some mushrooms are edible, and quite tasty, while others are edible but awful. The compact Russula he brought tastes fishy and stinks, while one thats called Bradley, in West Virginia, also tastes fishy but is delicious, he said.

Some mushrooms are toxic, and a few are deadly. Sturgeon said that In northeast Ohio, there are two common species that can kill you: Destroying angel, which is all white, and deadly galerina, also called autumn skullcap, that have brown or yellowish tops. Other varieties may not be fatal, but can make you very sick, including some of the so-called hallucinogenic mushrooms.

After eating 10 or so, you may find that your digestive system shuts down, he said.

The problem is, so many edible varieties resemble toxic ones, and vice versa. Thats why Sturgeon puts a skull and crossbones at the top of pages describing toxic varieties in his field guides. Poison control centers call Sturgeon often, mostly for kids, sometimes for dogs. Hes also on the Poisons Help: Emergency Identification for Mushrooms & Plants page on Facebook.

Sturgeon said in these cases, its important for parents to send good photos of the suspect mushroom. Pictures should show the cap, both from the top and underneath; the stem, and any other parts, plus one that is cut in half. The insides of some mushrooms turn blue, green or other colors when exposed to air, as Sturgeon demonstrated in his talk.

Unfortunately, panicked adults in these situations often arent thorough in their photography.

Its frustrating when they only have photos of vomit, or a mushroom thats in pieces, Sturgeon said.

Identifying mushrooms is so important, theres even an app for that. Sturgeon spends a lot of time looking at photos of mushrooms that people post on iNaturalist, sometimes identifying 100 or more a day. The site also has maps showing where those kinds of mushrooms have been found.

Of the edible varieties, morels are probably his favorite mushrooms, along with the American parasol. Sturgeon emphasized the need to always cook mushrooms. Even some types of morels will make you sick if you eat them raw, he said. Sturgeon also likes chanterelles, with their bright orange color and many wrinkles.

They taste fruity and have a nice smell, like apricots, he said.

Some people candy them and put them on ice cream or sorbet, but he just adds some maple syrup or honey after cooking them in butter.

Morels and hen-of-the-woods, called sheepshead locally, are the prizes around here, but chanterelles are catching on, he said.

Sturgeons dad took him mushroom hunting as a kid, but he really got interested in the 1970s when his wife, Trish, got him a mushroom book for Christmas. He joined the North American Mycological Association and the Ohio Mushroom Society, where he found a mentor.

He used to shoot photos of mushrooms on film and mail them to his mentor, who would mail back the identifications.

Among the books and field guides hes authored are Mushrooms of the Northeast and Appalachian Mushrooms: A Field Guide. Those in the southeast corner of Ohio can be a little different than those in the rest of the state, like the cauliflower mushroom that grows on conifers.

But theres also a big overlap, he said. Mushrooms dont know borders.

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Fungi foray: Wild mushrooms are a key part of food chain - Farm and Dairy

CLEVELAND When 61-year-old Ken Anderson was diagnosed with Multiple Myeloma 3 years ago, he didnt know what to expect.

It kind of hits you. It hits you hard, he said. Its a blood cancer, and its in your bone marrow, and it degenerates your bones is what it does.

The cancer is incurable, but treatable.

You live with it and you have to have many rounds of chemotherapy to keep the myeloma at bay, said Dr. Ted Teknos, the president of University Hospitals Seidman Cancer Center.

With so many unknowns, the dad of 4 girls and grandfather of 2 knew one thing, he was going to fight.

You just have to look to the road ahead, he said.

For the past 3 years, that road has been filled with ups and downs and countless rounds of chemotherapy treatments and even a bone marrow transplant.

They give you your stem cells back and those regenerate and lasted for about 6 months, and then there was a relapse, said Anderson.

Through it all, he remained hopeful for a medical breakthrough. He read about the research and followed up on the results of clinical trials in something called CAR T therapy.

I didn't know how far out that would be. It didn't say how far out it was. It sounded, to me, something like 10 or 20 years.

But it wasnt 20 years, the FDA approved CAR T therapy for Multiple Myeloma patients, and University Hospitals is the first in Ohio to treat patients with it. Anderson, who is from Kirtland, is the first patient in Ohio to receive it.

These treatments, now, are available for those that have run out of options, said Dr. Teknos.

Dr. Teknos compared the treatment to something straight out of a science fiction movie.

In essence, its like a heat-seeking missile for the cells to go find the cancer and eradicate it, he said.

It works by taking a patients own white blood cells, genetically modifying them in a lab and then infusing them back into their body so the patients cells can fight off the cancer cells.

They will engineer them to attack my cancer cells, said Anderson.

Dr. Teknos calls it living therapy.

You're taking living cells out of a patient, you're modifying them, and then you're growing them up in the lab and then re-infusing them back into the patient, he said. It's their own cells that have been modified and fight the cancer.

Dr. Teknos said in clinical trials, about 75% of Multiple Myeloma patients had a response to therapy, and in 1/3 of patients, their cancer went away.

Its really a game changer, said Dr. Teknos. There are patients who literally had weeks to live and then a year and a half later, have no cancer at all.

Andersons cells are currently in the lab. He will receive his infusion next month. He is cautiously optimistic that the next stop on his journey will have him feeling better.

I won't have to be on the chemo anymore, so I'm just back to feeling like myself would be would be really exciting, he said. People who are out there and diagnosed with this, with this disease, know that we are on the cusp of some big things here in the treatment of it, and this is a huge advance.

While Anderson is currently fighting Multiple Myeloma, University Hospitals is also offering a new CAR T cell therapy treatment for patients diagnosed with Diffuse Large B-Cell Lymphoma.

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University Hospitals treats first cancer patient in Ohio with "game changing" CAR T therapy - News 5 Cleveland

In the premarket trading session, at last check AGE stock surged by 7.2% to $1.34. AGE stock closed previous session at $1.25 losing -3.85%. The AGE stock volume traded 80189.0 shares. In the past year up-to-date AGE stock had jumped by 64.47% while in the past week the shares shed -6.02%

On 1st April 2021, the AgeX Therapeutics Inc. announced the business update and release of financial results of the fourth quarter 2020.

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The company had recently entered into a supported sponsored collaboration with The Ohio State Universit. This coordination is focused on the utilization of AgeX-BAT1 in mice. This candidate is based on AgeXs brown adipocyte tissue (BAT) cell treatment. The purpose of it is to decide if transplantation of AgeX-BAT1 cells may improve cardiovascular capacity, diet-incited obesity and metabolic wellbeing including glucose digestion.

AgeX has also partnered with a biopharmaceutical organization creating embryonic stem cell (ESC) derived mesenchymal stem cells (MSCs) known as ImStem Biotechnology Inc. The collaboration was based on non-exclusive sublicense that will contain royalties for the utilization of AgeXs clinical-grade ESC line ESI-053 to determine ImStems investigational MSC item candidate IMS001 for improvement in COVID-19 as well as acute respiratory distress disorder (ARDS) from different causes. ImStems MSC item up-and-comer IMS001 is based on AgeXs stem cell line ESI-053. In March 2020, IMS001 acquired FDA IND approval to start a human research in different sclerosis.

AgeX reported on March 12, 2021 the online distribution of research paper identifying with regeneration, maturing, and cancer in bioRxiv. The paper presents interesting information identifying with mechanisms that cells may use during the recovery period. The paper uncovers changes in specific qualities that may keep recovery from happening in aged people. It additionally gives proof that the group of qualities might be engaged with a wide exhibit of human tumors.

The fourth quarter and full year result for the year 2020 has overall positively improved as compared to the year 2019. When we look at the highlights posted by the company we see that the company for the fourth quarter of 2020 reported Total Revenues of $0.5 million. While for the year ended December 31, 2020 the total revenues were $1.9 million, compared to $1.7 million in the same period in 2019. The company increased the Operating expenses by $2 million to $12.4 million in full year 2020 as compared to 2019. The net loss attributable for AGE stock equals $0.29 per share in 2020 compared to $0.33 per share for the period 2019.

AgeX Therapeutics, Inc.,is a biotechnology company that specifically centers around the design, developmentand commercialization of novel therapeutics. These novel treatments areprimarily for human aging and degenerative illnesses. The organization was established in 2017 and is situated in Alameda,California.The company has its operations deployed in the market of United States. The organizations lead cell-based helpful candidate being developed consists of AGEX-BAT1, a cell treatment product for the treatment of different age-related metabolic issues, for example, Type II adult on-set diabetes.AgeX Therapeutics, Inc. has a research coordinated effort with the University of California, Irvine on neural foundational cell research program for Huntingtons sickness and other neurological disorders; and Sernova Corp.

The company also provides AGEX-VASC1, a cell-based treatment to reestablish vascular aid in ageing ischemic tissues, like the ischemic heart. Its lead drug-based investigative candidate is AGEX-iTR1547, for restoration of regenerative potential in a range of aged tissues affected by degenerative infections. Furthermore, the organization markets human embryonic stem cells; and GeneCards Database Suite, including genomic analysis calculations and analysis instruments for use by specialists at drug and biotechnology organizations, and different establishments.

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AgeX Therapeutics Inc. (NYSE:AGE) stock surged in the premarket trading session; heres why - Market Globalist

News and research regarding emerging new coronavirus variants are moving fast. To help you keep up, here's a 101-level explainer on what the new variants are, where they emerged, and more.

This explainer covers:

By now, we all know that officials reported the first cases of the novel coronavirus, known as SARS-CoV-2, late last year in Wuhan, China. The virus quickly spread throughout the world, touching every continent and nearly every country.

Throughout the pandemic, researchers have been testing samples of SARS-CoV-2 to detect whether the novel coronavirus developed any mutations as it spread, which can occur with RNA viruses such as influenza, HIV, the new coronavirus, and more. By May, scientists had identified at least one mutation, known as D614G, but research on whether the mutation made the virus more transmissible was largely inconclusive. However, by September, researchers had catalogued "more than 12,000 mutations in SARS-CoV-2 genomes," Nature's Ewen Callaway reports.

According to Callaway, many scientists suspected that, if a mutation didn't help the novel coronavirus to spread easier, it likely emerged when the virus was first mutating to jump from animals to humans or from human to human. But scientists didn't think it was likely that the virus would mutate to become more transmissible among humans at this point, because "[a]t a time when nearly everyone on the planet is susceptible, there is likely to be little evolutionary pressure on the virus to spread better, so even potentially beneficial mutations might not flourish," Callaway writes.

Put another way, William Hanage, an epidemiologist at the Harvard T. H. Chan School of Public Health, told Callaway, "As far as the virus is concerned, every single person that it comes to is a good piece of meat. There's no selection to be doing it any better."

Fast-forward just a few months, however, and officials in the United Kingdom had some troubling news. On Dec. 8, 2020, British officials announced that scientists had discovered a new, potentially far-more-contagious variant of the novel coronavirus in the United Kingdom. U.K. Prime Minister Boris Johnson and England's CMO Chris Whitty said scientists identified the new variantlabeled B 1.1.7through Public Health England's genomic surveillance. U.K. officials said the variant had about 20 mutations, including several that affect how the virus attaches to and infects cells in the body. Specifically, one of the mutations on B 1.1.7, called N501Y, improves how the spike protein of the viruswhich is the part of the virus that infects human cellsattaches to the ACE2 receptor on human cells, meaning the virus is more likely to infect cells successfully.

Johnson at the time said scientists believed the new variant was more infectious than the original version of the novel coronavirus, and the variant quickly became the dominant type of SARS-CoV-2 spreading throughout the country. According to recent research, B.1.1.7 appears to be about 56% more contagious than the unmutated virus, and researchers have now detected the variant in at least 45 countries, including the United States.

In the United States, researchers so far have detected B.1.1.7 in a handful of states, but experts say its possible the new variant is more widespread than we know. That's because the United States currently lacks a nationwide system for tracking how coronavirus genomes mutate, with researchers doing genome sequencing on fewer than 3,000 samples a week. Many of the Americans infected with B.1.1.7 haven't traveled recently, which suggests that the variant is already circulating throughout the country via community spread, officials have said.

But B.1.1.7 isn't the only new coronavirus variant on scientists' radar. They've also discovered a new variant in South Africa, called B.1.351, that similarly features the N501Y mutation, as well as an additional mutation called E484K. The E484K mutation occurs on a part of the spike protein that's instrumental in attaching the virus to ACE2 receptors, and it's also been found in a coronavirus variant circulating in Brazil.

Additionally, on Wednesday, researchers in Ohio reported identifying two additional new variants, including one that appears to be more transmissible than the original version of SARS-CoV-2 and may have originated in the United States. Not much is known about those new variants at this time, but researchers said the variant that may be more transmissible has become the dominant variant circulating in Columbus, Ohio.

Experts also predict that we could see additional more-contagious new variants of the novel coronavirus as more people gain immunity to the pathogen. Salim Abdool Karim, chair of South Africa's Covid-19 ministerial advisory committee, told the Financial Times, "We're going to see this occur more commonly now than in 2020, as we vaccinate and as more people are infected," because the virus will evolve to help it continue to spread.

FDA has warned health care providers that the new variants might elude some tests for the novel coronavirus and trigger false-negative results. FDA said that likelihood is low, but it noted three tests Applied DNA Sciences' Linea test, Mesa Biotech's hand-held Accula test, and Thermo Fisher's TaqPath combo kitthat might produce inaccurate results because of the variants' mutations. In a statement, FDA Commissioner Stephan Hahn said the agency is "working with authorized test developers and reviewing incoming data to ensure that health care providers and clinical staff can quickly and accurately diagnose patients infected with SARS-CoV-2, including those with emerging genetic variants."

But there is some good news: So far, there's no evidence that the new coronavirus variants cause more severe illness or higher mortality than the original version of the virus.

And although experts have expressed concern that some variants may be more resistant to current treatments for Covid-19, they say there's no evidence indicating as much so far, at least for the currently known variants.

For instance, Gilead Sciences is testing its Covid-19 treatment remdesivir on both B.1.1.7 and B.1.351, but the company's CEO, Daniel O'Day, on Monday said he believes remdesivir will be effective against them. "Remdesivir works at the source in the cell where the virus replicates, and what we know is, in these new variants, that part of the cell is not changing at all," he said.

It's more uncertain, however, whether monoclonal antibody treatments for Covid-19 will be effective against variants that have mutations to the portion of the novel coronavirus's spike protein that's targeted by those treatments. As a result, Eli Lilly CEO Dave Ricks on Tuesday told CNBC that he expects the company's antibody drug will be effective against B.1.1.7, but he's not sure whether it will work against B.1.351.

That's because B.1.351 "has more dramatic mutations to that spike protein, which is the target. Theoretically, it could evade our medicines," Ricks said. He added that Lilly intends to work with FDA to test different versions of the company's antibody drug against the new variants to gauge their effectiveness.

Separately, George Yancopoulos, Regeneron's research and development chief, on Monday said the company's antibody cocktail drug for Covid-19 could be effective against new coronavirus variants. "We think having a cocktail makes it more likely you'll be able to deal" with the new variants, because "[i]t reduces the likelihood that a single variant can become resistant to both antibodies in the cocktail," he said.

When it comes to vaccines, a study conducted by Pfizer and scientists from the University of Texas Medical Branch suggests that Pfizer's and BioNTech's coronavirus vaccine is effective in neutralizing the novel coronavirus with the N501Y mutation. That study hasn't yet been peer-reviewed, and it didn't look at the E484K mutation. Pfizer has said it plans to test its vaccine against the E484K mutation in coming weeks.

According to Medical News Today's Maria Cohut and Yella Hewings-Martin, experts have said Moderna's Covid-19 vaccine should be similarly effective against new variants.

Some studies have shown that viruses with the E484K mutation are not recognized as well by antibodies as other forms, meaning coronavirus variants with the E484K mutationsuch as B.1.351could potentially bypass immune protection. According to a pre-print paper from researchers at the Fred Hutchinson Cancer Research Center, the location of the E484K mutation is "the site of most concern for viral mutations." Overall, the paperwhich tracked how the antibodies in people who had recovered from Covid-19 fared against different variantsfound that while there was variability among the samples, some people experienced as much as a 10-fold drop in neutralization against variants with E484K.

Overall, however, while experts are concerned about the recent mutations, they say it's not likely that they'll render current Covid-19 vaccines and treatments entirely ineffective. According to experts, it would take yearsrather than monthsfor the novel coronavirus to mutate to a point where people's antibodies against the virus or currently authorized vaccines would become ineffective.

And as CDC recently explained, the United States' currently authorized Covid-19 vaccines "produce a 'polyclonal' response that targets several parts of the spike protein. The virus would likely need to accumulate multiple mutations in the spike protein to evade immunity induced by vaccines or by natural infection."

Jesse Bloom, an evolutionary biologist at the Fred Hutchinson Cancer Research Center, told the New York Times' Apoorva Mandavilli, "No one should worry that there is going to be a single catastrophic mutation that suddenly renders all immunity and antibodies useless." Noting that even the influenza virus needs between five and seven years to gather all the mutations necessary to evade immune recognition entirely, Bloom continued, "It is going to be a process that occurs over the time scale of multiple years and requires the accumulation of multiple viral mutations. It's not going to be like an on-off switch."

Regardless, vaccine manufacturers say they'll be monitoring whether they need to tweak their vaccines to address the new variants. For instance, BioNTech CEO Ugur Sahin recently said that, if the company's vaccine starts to lose its efficacy because of new variants, his company would be able to adjust its vaccine accordinglyand in an even shorter timeframe. "[T]he beauty of the messenger mRNA technology [that the BioNTech/Pfizer vaccine uses as a platform] is we can directly start to engineer a vaccine that completely mimics this new mutation and we could manufacture a new vaccine within six weeks," he said.

Since the United States doesn't yet possess the robust surveillance program needed to determine how widespread new coronavirus variants actually are in America, public health experts say the country essentially is "flying blind" when it comes to addressing them, the Times' Matt Apuzzo, Selam Gebrekidan, and Mandavilli report. Experts say implementing a national surveillance system in the United States would allow public health officials to warn people in areas affected by the new variants and quickly implement measures meant to stem their spread.

Without taking action to stop the new variants, and particularly B.1.1.7, they could become the dominant variants circulating in the United States within the next few weeks to a couple months, public health experts say. And while it's currently too soon to tell how the variants will affect the United States' coronavirus epidemic, experts are concerned more-contagious variants could accelerate the country's new case rate.

That's especially concerning because the United States already is seeing persistently high levels of hospitalizations and deaths tied to the novel coronavirus. Hospitals in some areas of the United States already are overwhelmed by a recent influx of Covid-19 patients, with some having to ration care. If the country sees new cases of the coronavirus and related hospitalizations accelerate even more, the situation could become increasingly diresimilar to what's happened in the United Kingdom, experts fear.

"Epidemiological models and Britain's experience indicate that, while only a few cases of the variant have been identified in the United States, it will likely become our dominant strain within a few months," Ashish Jha, a general internist and professor of global health at the Harvard T.H. Chan School of Public Health, and Robert Wachter, chair of the department of medicine at the University of California-San Francisco, write in a Washington Post opinion piece. And "a more infectious virus means more cases, which means more hospitalizations and deaths," they add.

As such, in addition to ramping up surveillance of the new variants in the United States, health officials say Americans need to double down on evidence-backed public health measures that curb the novel coronavirus's spread, such as wearing face masks, social distancing, and frequent hand washing.

"We don't have any evidence that the new variant can fundamentally evade masks, social distancing, or the other interventions," Jeff Barrett, director of the Covid-19 genomics initiative at the Wellcome Sanger Institute in the United Kingdom, told BBC News' Helen Briggs. "[W]e just need to apply them more strictly."

Further, health officials say federal and state health officials must work to get as many Americans vaccinated against Covid-19 as quickly as possible.

"We are in a race against time," Jennifer Nuzzo, an epidemiologist with the Johns Hopkins Center for Health Security, told the Post's Joel Achenbach and Ben Guarino. "We need to increase our speed in which we act so that we don't allow this virus to spread further and allow [B.1.1.7] to become the dominant one in circulation. The clock is ticking."

See the rest here:
Weekly line: What the new coronavirus variants mean for vaccines, transmission, and more - The Daily Briefing

COLUMBUS, Ohio, Jan. 4, 2021 /PRNewswire/ --Forge Biologics Inc., a gene therapy manufacturing and development company, today announced that the company has received FDA clearance of the Investigational New Drug (IND) to initiate a Phase 1/2 clinical trial evaluating its novel, first-in-human AAV gene therapy, FBX-101, for patients with Krabbe disease. FBX-101 is the company's first therapeutic program to receive an IND which also received Institutional Biosafety Committee (IBC) and Institutional Review Board (IRB) approvals required prior to any patient enrollment. This marks a major step forward in building out the company's hybrid model as a gene therapy manufacturing and development engine.

Krabbe disease is a rare and fatal pediatric leukodystrophy affecting about 1-2.6 in 100,000 people in the United States. Patients are born with mutations in the galactosylceramidase(GALC) gene, which encodes an enzyme that helps break down lipid molecules inside cells. This results in the toxic buildup of psychosine, a lipid molecule that can't be degraded in cells, particularly in cells in the brain and peripheral nerves, and leads to toxic levels that cause cell death and myelin loss. The disease initially presents as physical delays in development, muscle tightness and irritability, and rapidly advances to difficulty swallowing and breathing, loss of vision and hearing, and increasing cognitive degeneration. Early onset, or "Infantile", Krabbe disease cases usually results in death by age 2-4 years, while later onset or "Late Infantile" cases have a more variable course of progressive decline. There is currently no approved treatment for either form of Krabbe disease.

FBX-101 is an adeno-associated viral (AAV) gene therapy administered after hematopoietic stem cell transplant (HSCT), that delivers a functioning copy of the GALC gene, the enzyme needed to prevent the buildup of psychosine in myelinated cells of both the central and peripheral nervous system. FBX-101 has been shown to correct the central and peripheral myelination deficits, significantly improve the behavioral impairments associated with Krabbe disease in animal models, and drastically improve the lifespan of treated animals. The use of transplant and intravenous AAV gene therapy infusion has the potential to overcome some of the immunological safety challenges of traditional AAV gene therapies.

"The ground-breaking treatment approach using HSCT and AAV gene therapy, initially developed by Dr. Escolar, has safely demonstrated superior benefits in preclinical animal studies of Krabbe disease than either treatment method alone," said Timothy J. Miller, Ph.D., Forge's CEO, President, and Co-Founder. "We are grateful for the FDA's engaged review and allowance of the IND, and look forward to enrolling patients very soon."

FBX-101 is the culmination of nearly 20 years of Krabbe disease research, led by Maria Escolar, M.D., M.S., Chief Medical Officer at Forge Biologics and the pioneer for evaluating the natural history and new treatment approaches for patients with Krabbe disease. "This combination approach is extremely exciting because the preclinical data demonstrate significant correction of survival, behavior and neuromuscular function in animal models compared to either transplant or AAV treatment alone. This is a significant milestone for Krabbe disease families suffering from this deadly disease," said Dr. Escolar.

The initiation of the RESKUE trial in Forge's gene therapy pipeline continues Forge's momentum within the biotechnology industry in Columbus, Ohio, bringing positive impact to both Ohio and the global rare disease community.

Patients and families can learn more about clinical trials for FBX-101 by visiting https://www.forgebiologics.com/science/#krabbe.

About Krabbe diseaseKrabbe disease is a rare, pediatric leukodystrophy affecting about 1-2.6 in 100,000 people in the U.S. and is inherited in an autosomal recessive manner. Krabbe disease is caused by loss-of-function mutations in the galactosylceramidase (GALC) gene, a lysosomal enzyme responsible for the breakdown of certain types of lipids such as psychosine. Without functional GALC, psychosine accumulates to toxic levels in cells. The psychosine toxicity is most severe in the myelin cells surrounding the nerves in the brain and in the peripheral nervous system, eventually leading to the death of these cells. The disease initially manifests as physical delays in development, muscle weakness and irritability and advances rapidly to difficulty swallowing, breathing problems, cognitive, vision and hearing loss. Early onset or "Infantile", Krabbe disease cases usually results in death by age 2-4 years, while later onset or "Late Infantile" cases have a more variable course of progressive decline. There is currently no approved treatment for Krabbe disease.

About FBX-101Forge is developing FBX-101 to treat patients with infantile Krabbe disease. FBX-101 is an adeno-associated viral (AAV) gene therapy that is delivered after a hematopoietic stem cell transplant. FBX-101 delivers a functional copy of the GALC gene to cells in both the central and peripheral nervous system. FBX-101 has been shown to functionally correct the central and peripheral neuropathy and correct the behavioral impairments associated with Krabbe disease in animal models, and to drastically improve the lifespan of treated animals. This approach has the potential to overcome some of the immunological safety challenges observed in traditional AAV gene therapies.

About Forge BiologicsForge Biologics is a hybrid gene therapy contract manufacturing and therapeutic development company. Forge's mission is to enable access to life changing gene therapies and help bring them from idea into reality. Forge has a 175,000 ft2 facility in Columbus, Ohio, "The Hearth", to serve as their headquarters. The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing.By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most.

For more information, please visit https://www.forgebiologics.com.

Patient, Pediatrician, Genetic Counselors & Family Inquiries

Dr. Maria EscolarChief Medical OfficerForge Biologics Inc.[emailprotected]

Media Inquiries:

Dan SalvoDirector of Communications and Community DevelopmentForge Biologics Inc.[emailprotected]

Investor Relations and Business Development

Christina PerryVice President, Finance and OperationsForge Biologics Inc.[emailprotected]

SOURCE Forge Biologics

https://forgebiologics.com

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Forge Biologics Announces FDA Clearance of Investigational New Drug Application for Phase 1/2 Clinical Trial (RESKUE) of FBX-101 Gene Therapy for...

Memories come to him like flashes of light.The old football coach reaches back in his mind, grips what he can and hurls it into the air.

One word here. Another there.

Football.

Volleyball.

Catalina.

John Featherstonebetter known simply as Feather, the fiery, passionate and championship-winning coach who for three decades ruled California junior college football ranksis in a memory care facility near his home in Redondo Beach.

The 71-year-old last coached football in 2015, last played volleyball last year and last visited Catalina Island on Aug. 5, two weeks before a seizure left him listless and hospitalized. Seven years into dealing with Alzheimers, the latest medical event further hampered a once mighty man.

Joe Robbins/Getty Images

Physically, he is mostly fine, having now recovered from the seizure. He laughs, smiles and even dances to old hits like Sweet Caroline. He can and has thrown and caught a football. He hugs, he kisses and he still flirts with the ladies.

Mentally, he is not fine. He has been unable to use a phone for three years. Well before that, he stopped driving altogether. The most simple tasks, such as removing a shirt from his dresser and slipping it onto his torso, are impossible. Months ago, he stopped riding his bike to the beach because he would lose it so often.

His speech is now slipping, and communicating with him through FaceTime has grown difficult. Because of the pandemic and an outbreak at the facility this fall, no one from his family has seen him since November. The familys financial resources are dwindling, putting his stay at the care home at risk.

Featherstones situation got tougher on Saturday. He tested positive for COVID-19. Hes now further isolated from the world, quarantined in a separate wing of the facility in which hes spent the last several months, his family hoping he does not develop symptoms.

They FaceTime with him quite often. He says a word here or there.

Football.

Volleyball.

Catalina.

But there is another word he utters. The old football coach reaches back into his memory bank, recalling the young baseball player who he persuaded to play football and the software salesman he first hired as a coach.

Sark.

***

Steve Sarkisian kneels with another player while El Camino College coach John Featherstone smiles in the background.

Courtesy of Ryan Winkler

He used to call him Stevie, not Sark.

In 1993, when Steve Sarkisian arrived at El Camino College, a junior college football powerhouse on the outskirts of Los Angeles, he was a failed college baseball player whod transferred from USC before completing his freshman year.

He was done with football, or so he thought.

Then John Featherstone entered his life as his new P.E. professor. Having watched Sarkisian play high school ball at nearby West Torrance, the coach badgered Stevie to give football another crack.

So during the final week of spring practice that year, Sarkisian relented. He agreed to throw passes at practice. Two years later, he left El Camino as its most decorated passer, then signed a scholarship with BYU, starred as a record-breaking QB for LaVell Edwards and then found himself back in the South Bay area selling software.

He casually dropped by an El Camino practice one day and there was his old P.E. teacher, relentlessly pursuing him again. Come coach! Featherstone told him, recalls Gene Engle, a longtime assistant at El Camino.

Sarkisian began coaching quarterbacks, eventually called plays from the booth and, after that season, was hired at USC as a graduate assistant.

The rest, Engle quips, is history.

Sarkisian is the most accomplished branch on Featherstones coaching tree, made more certain with his hire over the weekend as the new head coach at Texas. It is truly a second-chance story, the details of which have been exhaustively reported. Fired at USC for substance use. Checked into a rehab clinic. Cleaned up his act. And then joined forces with Nick Saban at Alabama to assemble one of the countrys most explosive offenses.

Before beginning full-time duties with the Longhorns, hell lead the No. 1 Crimson Tide (120) into the national championship game next Monday against Ohio State (70) in Miami. Across the country, some 2,700 miles away, his old coach, the man who sparked his career in the sport, cannot comprehend what his ex-pupil has accomplished.

I dont think he knows whats happening, says Diane Featherstone, the coachs wife of seven years.

The two married just before John Featherstone was diagnosed with Alzheimers. This is a late-life love story that began with a courtship in 2009 and still hums along today. Diane, 77, cared for John until she couldnt. She and Johns four daughters agreed to send him to a home earlier this fall after he recovered from the seizure.

Diane hasnt seen her husband since Nov. 21.

I used to go to see him and hed cry in my arms, he was so happy to see me, she says. Now I cant do that and its killing me. I see him on FaceTime and thats it. Sometimes he knows me and can focus. But if the nurse leaves the room, he doesnt know where to look. I tell him I love him all the time. One time he told me, I love you, too.

Signs of the disease were obvious in Johns final two seasons as coach at El Camino in 2014 and 15. Assistants noticed him repeating himself. Hed forget a players jersey number or name. Engle, his right-hand man for 31 seasons at El Camino, assumed many of his friends duties late in his tenure.

When healthy, Featherstone reminded Engle most of Lou Holtz, a small figure in stature who inspired such stirring passion among his players and exuded so much intensity.

But that man, the one who won 214 games, 11 conference championships, two state titles and the 1987 national championship, was fading. The guy who inspired thousands of playersincluding ones who went on to the NFL like Marcel Reece, Matt Simms and Antonio Chatmandelivered the most fiery pregame speeches and called nearly every offensive play, was deteriorating in front of everyones eyes.

That was a tough part to watch, says Ryan Winkler, an assistant at El Camino who played for Featherstone and was on staff for his final years. He was still swimming in the ocean each morning, playing volleyball and coming to practice. He was healthier physically than anybody out there including players. Mentally, he wasnt there.

Alzheimers is a brutal disease. Brain cells themselves degenerate and die, eventually destroying memory and other mental functions. Medications and management strategies may temporarily improve symptoms, but no cure exists. The end result is almost always the same. Life expectancy after diagnosis is about three to 11 years, according to the Mayo Clinic.

Ill be honest, Winkler acknowledges, a part of me wants to remember him for how he was.

For years, family and friends kept his diagnosis a secret. He was in denial about the illness for a while, says Diane, carrying on with life and coaching as if nothing were wrong. The two didnt discuss the topic. Alzheimers wasnt mentioned.

When doctors found traces of trauma in Featherstones brain which they say likely stem from injuries sustained in childhood and while playing football, they didnt talk much about that either. Concussions, says Diane, who holds no resentment toward a game that her husband built his career and life around (every Saturday, you can still find her watching college football from her couch).

But inaction was not an option. Last fall, they publicly revealed their secret.

We have no choice, Diane says.

Engle and Diane recently began a GoFundMe page to keep John at Belmont Village Senior Living. While that effort has generated nearly $80,000much of it from former playersits only enough to keep him at Belmont for seven more months, give or take.

The memory care facility provides John more amenities than a normal senior home. He takes medication and participates in memory exercises to slow the deterioration. Its a more comfortable community setting versus just sitting at a senior home and staring at a TV, Engle says.

When the GoFundMe first went live, the outpouring was jaw-dropping. Some gave $10, others $500 and several donated four figures. The donations often came with a phone call, email or face-to-face interaction.

As hard as this disease is, it has brought a lot of people out sharing so many stories about him that we may have not heard, says Keegan Felix, one of Featherstones daughters. We have had players come up to us and say, Your dad saved my life. I would have been dead or in jail.

Some donations came from players who never even lasted at El Camino.

You start going down the GoFundMe list and there are guys on there that youd never think would be on there, says Derrick Deese, a former NFL offensive lineman who played for Featherstone at El Camino. They now get itthey learned a lot from him. It wasnt just about football. It was bigger than football.

Through Deese, the family got a message to Sarkisian about his former coachs condition and the fundraising campaign. A day afterward, an anonymous four-figure donation appeared on the GoFundMe page, says Deese.

***

In 2013, John Featherstone visited then-Washington coach Steve Sarkisian in Seattle.

Courtesy of Diane Featherstone

Feather and Sark were close for years. But after Sarkisians firing at USC, communication between him and other members of the El Camino staff stopped, Engle says. The last time the two saw each other was at a spring practice on USCs campus in 2015, a few months before Sarkisian lost his job for alcohol-related issues. A couple of years before that, the Featherstones traveled to a Washington Huskies game in Seattle while Sarkisian was coach. Sarkisian even allowed his old coach to speak to the team. Diane was there as her husband, in the early stages of his secret disease, delivered an impassioned address.

Featherstone watched the game from the field, once again sharing a sideline with his former player and assistant. The trip was significant. It kicked off Diane and Johns retirement planto travel each weekend to a football game, exploring the city and campus. The retirement plan never really materialized. The disease took it from them.

And now, years later, a virus has taken away their ability to even see one another.

Its heartbreaking, Diane says. But whats interesting is over the last year hed only bring up certain names. He always said Sark. Wonder where Sark is. Whats Sark doing? As we were watching football, Id tell him that Sark is coaching that game.

As his condition has deteriorated, he could only recently utter his name.

Sark.

Diane believes that the simplicity of the wordfour letters and a single syllablemakes it conducive for her husband to pronounce.

Anytime hed see him on TV, hed say Gosh, look at him! Felix recalls. He was so proud of him.

John Featherstone smiles for the camera during an outing with his wife Diane in October.

Courtesy of Diane Featherstone

In the most recent FaceTime with Featherstone, Diane asked her husband how he was feeling. He mumbled something, and according to the nurse, he said, "Happy."

She's attempted to explain to him the details of Sark landing his big new job, but whether he understood or not remains a mystery. In the past, when he was more coherent, he'd watch football, see Sarkisian on screen and immediately sit up. He'd get anxious and believed that he should be there with his pupil. "We've gotta go now!" he'd tell Diane.

In many ways, Featherstone saw himself in Sarkisian. They're not the most physically gifted men, but natural-born leaders who could captain a huddle, deconstruct a defense and scheme offensively.

It was so fun to get on the board with Stevie. He was like a mad scientist, Featherstone said in an interview in 2017 with 247Sports. I could tell he was a leader. He didnt want to be in the back of the roomhe wanted to be in the front. I was that guy, too.

That was one of the last public recorded interviews in which Featherstone participated. In the video, he is seated on a bench near the Redondo Beach Pier. Hes smiling incessantly while speaking about his former quarterback, the Pacific Coast breeze blowing through his slicked-back hair. Its a lasting image. At the time, few knew about the disease slowly encroaching on his life.

In November 2019, in a ceremony that he attended, El Camino named its football field after Featherstone. He came bursting out of the tunnel with the 2019 Warriors and their new coach, racing onto Featherstone Field as if he were still leading the squad.

A bronze plaque now hangs at the stadium detailing Featherstones on-field, numerical accomplishments. But it is the plaques six other words that reverberate.

Mentor, teacher, coach and loyal friend, it says.

Even without his presence in public life, John Featherstones legacy lives on through those he inspired. At the top of the list is one of college footballs most brilliant and innovative minds: the new head coach at the University of Texas.

Sark.

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The Rise of Steve Sarkisian ... And the Decline of the Man Who Got Him Here - Sports Illustrated