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DetailsCategory: DNA RNA and CellsPublished on Monday, 04 October 2021 20:29Hits: 295

-- 65% of Patients Achieved Overall Complete Remission with Tecartus --

-- High Unmet Need: Fifty Percent of Adult Patients Will Relapse on Currently Available Treatments --

-- Approval Marks Kites Fourth Indication for its Cell Therapies and First in Leukemia --

SANTA MONICA, CA, USA I October 01, 2021 I Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has granted approval for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Following FDA Breakthrough Therapy Designation and a priority review, Tecartus is the first and only chimeric antigen receptor (CAR) T-cell therapy approved for adults (18 years and older) with ALL. There is a high unmet need, as half of this patient population will relapse, and median overall survival (OS) is only approximately eight months with current standard-of-care treatments. Patients can access Tecartus through 109 authorized treatment centers across the U.S.

Adults with ALL face a significantly poorer prognosis compared to children, and roughly half of all adults with B-ALL will relapse on currently available therapies, said Bijal Shah, MD, ZUMA-3 investigator and medical oncologist, Moffitt Cancer Center, Tampa, Florida. We now have a new meaningful advancement in treatment for these patients. A single infusion of Tecartus has demonstrated durable responses, suggesting the potential for long-term remission and a new approach to care.

The approval is based on results from ZUMA-3, a global, multicenter, single-arm, open-label study in which 65% of the evaluable patients (n=54) achieved complete remission (CR) or CR with incomplete hematological recovery (CRi) at a median actual follow-up of 12.3 months. The duration of CR was estimated to exceed 12 months for more than half the patients. Among efficacy-evaluable patients, median duration of remission (DOR) was 13.6 months. Among the patients treated with Tecartus at the target dose (n=78), Grade 3 or higher cytokine release syndrome (CRS) and neurologic events occurred in 26% and 35% of patients, respectively, and were generally well-managed.

Today marks Kites fourth FDA approved indication in cell therapy in under four years, demonstrating our commitment to advancing CAR T for patients across many different hematologic malignancies, said Christi Shaw, Chief Executive Officer of Kite. Tecartus has already transformed outcomes for adults living with mantle cell lymphoma, and we look forward to offering the hope for a cure to patients with ALL.

Adults with relapsed or refractory ALL often undergo multiple treatments including chemotherapy, targeted therapy and stem cell transplant. CAR T-cell therapy works differently, by harnessing a patients own immune system to fight cancer. With CAR T, the patients blood is drawn and the T cells are separated. Then the T cells are genetically engineered with a specific receptor that enables them to identify and attack cancer cells, and put back into the patients body.

Roughly half of all ALL cases actually occur in adults, and unlike pediatric ALL, adult ALL has historically had a poor prognosis, said Lee Greenberger, PhD, Chief Scientific Officer of The Leukemia & Lymphoma Society (LLS). Developing new therapies that would be life-changing for people with cancer has been a dream of LLS. We are proud to see the potential of CAR T realized for even more people with this approval for brexucabtagene autoleucel.

Tecartus is also currently under review in the European Union and United Kingdom for the treatment of adult patients with relapsed or refractory B-cell precursor ALL.

The Tecartus U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Tecartus is approved with a Risk Evaluation and Mitigation Strategy (REMS) due to these risks; see below for Important Safety Information.

Additional Information About ZUMA-3 Trial

Further efficacy results from the ZUMA-3 trial have been published and presented in scientific forums. Published Phase 1 data showed 32% of responders (n=22) were still in remission at the median follow-up of 22.1 months. In Phase 2 data presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, investigators reported that among treated patients (n=54), 31% of these patients were in ongoing response at a median follow-up of 16.4 months. 97% of responders had deep molecular remission, with undetectable minimal residual disease (MRD), and median OS among all responders has not yet been reached. A safety analysis, reported in the Lancet, showed among all patients who experienced a neurologic event, 94% of CRS events and 88% of neurologic events were resolved.

ZUMA-3 is an international multicenter, registrational Phase 1/2 study in adult patients (18 years old) with ALL whose disease is refractory to or has relapsed following first standard systemic therapy with remission of 12 months or less, after two or more lines of systemic therapy or at least 100 days after allogeneic stem cell transplantation. Seventy-one patients were enrolled (and leukapheresed) in the study, and the primary endpoint was overall complete remission rate (OCR, equaling complete remission plus complete remission with incomplete hematologic recovery) as determined by an independent review.

About ALL

ALL is an aggressive type of blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system and other organs. Approximately 1,000 adults are treated annually for relapsed or refractory ALL. B-cell precursor ALL is the most common form, accounting for approximately 75% of cases, and treatment is typically associated with inferior outcomes compared with other types of ALL. Survival rates remain very poor in adult patients with relapsed or refractory ALL, with median OS at less than eight months.

About Tecartus

Tecartus is an autologous, anti-CD19 CAR T-cell therapy. Tecartus uses the XLP manufacturing process that includes T cell enrichment, a necessary step in certain B-cell malignancies in which circulating lymphoblasts are a common feature. Tecartus is also being evaluated in pediatric ALL, where its use is investigational, and its safety and efficacy have not been established.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with commercial manufacturing operations in North America and Europe. Kites singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit http://www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Tecartus Indication

Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

SOURCE: Kite Pharma

Link:
US FDA Approves Kite's Tecartus as the First and Only Car T for Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia | DNA RNA and...

Following the courts decision in US Stem Cell Clinic, CBER Director Peter Marks, M.D., stated in an FDA Voices blog post that the agency will continue cracking down on unapproved products marketed as regenerative medicine therapies, citing how the US Stem Cell decision is a victory for public health and an endorsement of the FDAs work to stop stem cell clinics that place patients at risk by marketing products that violate the law. Dr. Marks also referred to a second injunction case, United States v. Cell Surgical Network et al., which is currently being litigated in the U.S. District Court for the Central District of California, and a third enforcement action pursued by the FDA involving the seizure of vials of Vaccinia Virus Vaccine, Live, which was resolved in March 2018.

Since 2015, FDA has been documenting violations of current Good Manufacturing Practice (cGMP) requirements for tissue products by US Stem Cell Clinic. The agency issued aWarning Letterto the clinic in August 2017, which weanalyzed here. The clinic claimed that FDAs cGMP regulations were not applicable because the treatment falls under FDAs same surgical procedure and 361 HCT/P exceptions to regulation under the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA). In June 2019, a Florida district court ruled in favor of FDA, and enjoined the clinic from offering its stem cell therapy to patients.

As we summarized (here), the district courtfoundthat the population of stromal and vascular cells in US Stem Cell Clinics therapy, known as stromal-vascular fraction (SVF), requires FDA approval of a New Drug Application (NDA) or a Biologics License Application (BLA) before it can be commercially marketed. The court also found that the therapy was adulterated and misbranded because of the clinics manufacturing procedures and that its promotion violated statutory requirements.

On appeal with the Eleventh Circuit, US Stem Cell Clinic again argued it is exempt from regulation under the FDCA because the procedure falls into the same surgical procedure exception at 21 C.F.R. 1271.15(b). This provision states that FDAs regulation does not apply if you are an establishment that removes HCT/Ps from an individual and implants such HCT/Ps into the same individual during the same surgical procedure. Arguing before the District Court, FDA had successfullyassertedthat the SVF implanted into the clinics patients does not constitute such HCT/P removed from the patient due to the processing steps applied to the SVF in this case, meaning US Stem Cell Clinic was not covered by this exception.

In prefacing its analysis, the Eleventh Circuit notably explained that it was not merely offering judicial deference to FDA, saying it was giving the agencys view no special weight. The court said that although [t]here was a time when a court faced with a regulation that seemed impenetrable on first read might simply wave the ambiguity flag and defer to the agencys interpretation, this is the case [n]o longer. Rather, the court carefully consider[ed] the text, structure, history, and purpose of [the] regulation, and resolved the apparent ambiguity in FDAs favor.

First, the court considered the clinics argument that cells or tissues can be HCT/Ps only if they are intended for implantation into a patient, and it is the SVF and not the adipose tissue that is intended for implantation. The court rejected this defense, explaining that because adipose tissue contains the SVF, and because HCT/Ps are articles containing or consisting of human cells or tissues that are intended for implantation into a patient, both the adipose tissue and the SVF are HCT/Ps subject to regulation.

Second, US Stem Cell Clinic argued that an HCT/P re-implanted into a patient meets the regulatory definition of such HCT/P if it is like or similar to the HCT/P removed from the patient. The Eleventh Circuit disagreed. Instead, the court adopted FDAs interpretation that such HCT/P refers to the antecedent HCT/P removed from the patient in its original form. The Eleventh Circuit agreed with FDA and the District Court that the SVF procedure does not fall within the same surgical procedure exception because the biological material implanted into the patient is not the same as that removed. The court cited a history of FDA treating such HCT/Ps as meaning HCT/Ps in their original form that have not been subjected to significant processing.

The clinic also argued on appeal that it is exempt from regulation under the FDCA and PHSA because the procedure falls into the 361 HCT/P exception, whereby an HCT/P meeting four criteria (set forth in 21 C.F.R. 1271.10(a)) is deemed a 361 HCT/P, meaning that it is regulated solely under Section 361 of the Public Health Service Act (PHSA) and its implementing regulations in 21 C.F.R. Part 1271. Being deemed a 361 HCT/P subjects a therapy to a lighter regulatory burden. However, the Eleventh Circuit ruled that the 361 HCT/P exception does not apply because the HCT/P in this case is not intended for homologous use only.

Homologous use is the repair, reconstruction, replacement, or supplementation of a recipients cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor. 21 C.F.R. 1271.3(c). US Stem Cell Clinic argued that SVF meets the homologous use criterion of a 361 HCT/P because SVF was intended to perform the same basic regenerative function both before and after the procedure. However, the District Court determined that the Clinic intended that the SVF treat a litany of illnesses in the recipient, which is not the same basic function that the SVF performed prior to the procedure.

The Eleventh Circuit agreed with the District Court that the clinic intends the stem cells to perform functions after the procedure that are beyond the basic functions the stem cells performed prior to the procedure. The court said that promotion of an HCT/P for an unproven therapeutic use, such as curing cancer, would be a nonhomologous use, and thus the 361 HCT/P exception does not apply in this case. In making this determination, the court said it relied upon the labeling, advertising, and other indications of the manufacturers objective intent. Because the defendants had marketed their SVF therapy to treat an array of diseases, the court found the clinic could not argue the pre-procedure SVF cells were intended to have performed the same function as the re-implanted SVF cells.

In issuing its opinion, the court permanently enjoined US Stem Cell Clinic from offering its adipose stem cell therapy unless and until several conditions were met, including FDA approval of a new drug application or biologics license application for the SVF solution.

In 2017, FDA published a new regenerative medicine policyframeworkconsisting of four guidance documents, which provided for a grace period of risk-based enforcement discretion for certain HCT/Ps, which ended on May 31, 2021. This grace period was meant to give certain manufacturers time to assess whether they need to file an IND or marketing application with FDA, or whether they met the four regulatory criteria for continuing to market their products solely under the authority of section 361 of the PHSA, which does not require pre-market review and approval.

Following up on the governments victory in this legal battle, CBER Director Peter Marks, M.D., published a blog on June 3 warning that FDA will be cracking down on unapproved products marketed as regenerative medicine therapies, citing how the Eleventh Circuit affirmed the lower courts judgment in US Stem Cell as cause for the renewed admonition. Marks wrote that the US Stem Cell decision is a victory for public health and an endorsement of the FDAs work to stop stem cell clinics that place patients at risk by marketing products that violate the law.

More recently, on July 9, CBER added a Q&A page on its website about the end of the HCT/P enforcement discretion period, drawing a clear line in the sand to convey that FDA is serious about the end of enforcement discretion period. Notably, the Q&A page directs physicians not to administer an HCT/P that does not qualify for 361 HCT/P status, until that HCT/P has a BLA, unless that physician is studying the HCT/P as a clinical investigator in a clinical trial under an IND. It also appears to say that there is no grace period for products that were introduced into interstate commerce before May 31, 2021 and are still on the market.

This was the not the first time that CBER has warned of impending enforcement of its regenerative medicine policy framework; in an FDA Voices blog post on April 21, Marks had written that the agency will not again extend the grace period for HCT/P companies to come into compliance with its regenerative medicine policy framework. In both that article and the June 3 publication, Marks emphasized that FDA has taken and will continue to take action regarding unlawfully marketed HCT/Ps. Most recently Marks wrote that, since December 2018, the FDA has issued 400 letters to manufacturers and health care providers who may be offering violative stem cell or related products. In addition, since 2017, FDA has issued 14 Warning Letters and 24 Untitled Letters involving violative HCT/Ps, Marks wrote.

We recently analyzed (online here) the significance that these warnings carry for companies in the regenerative medicine space, and outlined the potential risks of noncompliance. These risks go well beyond FDA enforcement, and include the possibility of FTC action, False Claims Act liability, product liability claims, and susceptibility to private lawsuits.

[View source.]

Continued here:
Times really up! FDA authority to crack down on regenerative medicines upheld as grace period ends - JD Supra

The report for the worldwideAnimal Stem Cell Therapy marketgives a harsh thought regarding the various factors and patterns influencing the improvement graph of the worldwide market. Advancement of the effect of government strategies and guidelines on the activities in the Animal Stem Cell Therapy market is likewise referenced to offer a comprehensive synopsis of things to come viewpoint of the market. It presents refined development gauges for the Animal Stem Cell Therapy market based on dependable information and contains top to bottom information identified with the predominant elements of the market.

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Driving Industry Players:ANIMAL CELL THERAPIES, Celavet, Animacel, VETSTEM BIOPHARMA, Cell Therapy Sciences, Magellan Stem Cells, Cells Power Japan, Animal Care Stem, Aratana Therapeutics, VetCell Therapeutics, MediVet Biologic, U.S. Stem Cell, J-ARM

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Animal Stem Cell Therapy Market Size, Industry Analysis, Growth Factors, Trends, and Regional Forecast to 2027 - The Courier

Jakobe Kobe Washington is eight years old, loves baseball and is fighting an aggressive form of leukemia.

The Florida boy, who is known to pray for other kids in the hospital, needs life-saving blood stem cells or a bone marrow transplant. So far, his family has been unable to find a match.

On Saturday, Be The Match and the Icla da Silva Foundation will host a drive-through swab event at Irving Mall to try to find a match for Kobe, who has extended family in North Texas.

Its tough to see your kid fighting a fight, and you cant do anything but be there to support him, no control in it at all, Kobes father Jordan Washington, who is from Dallas, told the ABC affiliate in Tampa Bay, Fla.

Every year, more than 12,000 patients turn to Be The Match, a national marrow donation program, to search for blood stem cells or a bone marrow donor to help cure them of blood cancers, such as leukemia and lymphoma, according to a release about the event.

Roughly half of those patients are unable to find a match, with only 23% of Black patients like Kobe finding a match, compared to 77% of white patients, according to the Icla da Silva Foundation, which serves as a recruitment center for Be The Match and focuses on minority populations.

Thats because race and ethnicity play a key role in stem cells and marrow, and of the 22 million potential donors on the registry, only 4% are Black.

Potential donors ages 18 to 44 are encourages to go to the Irving Mall, 3880 Irving Mall, between 10 a.m. and 2 p.m. Saturday.

Participants will then register from their phones and take a swab of their inner cheek.

Those unable to attend can text 4Kobe to 61474 to complete the online registration and have a cheek swab kit sent to their home.

Originally posted here:
An 8-year-olds search for bone marrow match in battle with leukemia comes to North Texas - The Dallas Morning News

WOBURN, Mass., March 9, 2021 /PRNewswire/ --Today, Eirion Therapeutics, Inc., an aesthetic dermatology company headquartered in Woburn, Massachusetts, announced a deal with Shanghai Haohai Biological Technology Ltd. ("Haohai") that will result in a $32 million Series A Preferred Stock investment into Eirion along with exclusive licenses that will be for all of Eirion's products for the territory of China in exchange for an upfront payment in the amount of $8 million. The deal is structured in segments over the next approximately 18 months. Haohai is a leading Chinese aesthetic medicine company headquartered in Shanghai and is publicly traded on the Hong Kong (6826.HK) and Shanghai (688366.SS) stock exchanges.

"This transaction allows Haohai to bring Eirion's very innovative product candidates into China. As a leading aesthetic company with products ranging from dermal fillers to electro-optic equipment in China, Eirion's highly complementary products have the potential to catapult Haohai to becoming a dominant player in Chinese aesthetic field," said Haohai's Chairman Dr. Yongtai Hou.

Haohai is investing $31 million and a US investor is co-investing $1 million in Eirion that in aggregate will obtain a minority stake in the company. Eirion has been funded previously through approximately $11 million of convertible notes which will convert into Series A Preferred Stock in connection with Haohai's investment.

"We are thrilled to partner with Haohai, an established aesthetics leader in China, a country poised to become the largest aesthetic market in the world. Together, we look forward to accelerating innovation in the global marketplace," commented Jon Edelson, MD, Eirion's Chairman, CEO, and President.

The companies have signed two product licenses that have the potential in aggregate to provide Eirion approximately $43 million in development fees, $444 million in sales milestones, with product royalty rates ranging from high single digits to the low twenties. One license is for Eirion's neuromodulator-based product candidates, ET-01 (topical) and AI-09 (injectable) for aesthetic indications; and a second license is for Eirion's small molecule product candidates, ET-02 (topical) and ET-03 (oral), which are intended for the treatment of hair loss and hair greying. Under the terms of the licenses, the products will be manufactured in the US by Eirion and developed and commercialized by Haohai in China.

"My work as a clinical advisor and investigator with the Eirion team has given me a front row seat to see the Eirion team's commitment to scientific rigor and the aesthetic dermatology space. This transaction gives Eirion an even greater platform and set of resources to realize and expand the opportunities that they have identified," stated Kenneth Beer, MD. Dr. Beer is a noted clinical investigator and dermatologist in private practice in Florida.

Eirion's Technology

Eirion has invented a proprietary approach to topical neuromodulator treatment: before the application of the topical neuromodulator, the skin will be pre-conditioned by a device that will create temporary micropores that aide in the absorption of the neuromodulator into the skin. The topical neuromodulator itself employs a patented nanoemulsion delivery system. The treatment in total is intended to avoid the pain and potential bleeding, bruising and needle misplacement that can associated with the current hypodermic needle administration used for all commercial neuromodulators today.

Eirion's Clinical Product

Eirion's lead product ET-01 is a Phase 2 topical neuromodulator product candidate being developed for the treatment of lateral canthal lines (Crow's Feet wrinkles) and primary axillary hyperhidrosis (excessive underarm sweating). In its Phase 2 clinical trials to date using its drug-device combination, Eirion has observed the potential for ET-01 to treat wrinkles, with results that are statistically significant, showing improvements measured at muscular contraction when the Crow's Feet wrinkles appear at their worst on the face. Eirion has also observed promising effects and duration of effects of a single application of ET-01 in the physician's office when compared to the effects of a single injection observed in published studies of a commercially available neuromodulator. Eirion plans to begin a Phase 2b study this year to further study the efficacy and safety of ET-01.

Eirion's Pre-Clinical Products

Eirion is developing a next generation ready-to-use liquid injectable neuromodulator product called AI-09 for the treatment of glabellar (frown) lines. Eventually, AI-09 may be developed for other aesthetic and medical indications. AI-09 will be provided as a ready-to-use, liquid formulation, which contrasts favorably to currently commercialized neuromodulator products that all require reconstitution with saline in the physician's office before use. As well, in contrast to current injectable products, AI-09 does not contain human albumin, which carries a risk of disease transmission. Both ET-01 and AI-09 have been shown to be stable at room temperature for at least 3 months, which is also an advantage over current products that require shipping to and storage at the physician's office in frozen conditions. Eirion plans to file an IND for AI-09 later this year.

Eirion's pre-clinical product candidates ET-02 and ET-03, which contain the same small molecule, employ a brand-new mechanism of action which corrects an aging defect in the hair follicle stem cells that Eirion has discovered causes androgenic alopecia (hair loss) and hair greying. Eirion believes that ET-02 and ET-03 can either prevent the defect from occurring or reverse the defect which would result in either new hair growth in those who have lost hair or the return of hair color for those how have turned grey. Eirion believes our product candidates are the first potential pharmaceutical treatments in development for hair greying.

In controlled non-clinical studies of human scalp tissue affected by androgenic alopecia, ET-02 demonstrated approximately twice the hair growth compared to a control treatment over approximately 4months, which was statistically significant, and amounted to approximately three times the hair growth per centimeter over that which was observed in minoxidil clinical trials that were 12 months in duration. Eirion plans to launch its first clinical trial of ET-02 next year.

About Eirion Therapeutics, Inc.

Eirion Therapeutics, Inc. is a privately held, clinical stage biopharmaceutical company that is developing next-generation prescription products for aesthetic dermatology. Eirion currently has a rich pipeline of products focusing on treatments for wrinkles, primary axillary hyperhidrosis, androgenic alopecia, and hair greying. In the future, Eirion plans to also pursue additional indications that address other major unmet clinical needs for physicians and their patients. At the 2020 Fall Clinical Dermatology conference, Eirion competed in, and then won, the business "shark tank" contest called the Skin Health Innovation Competition. For more information, please go to http://www.eirionthera.com.

About Shanghai Haohai Biological Technology, Ltd.

Haohai Biological Technology is a leading company in China focusing on the research and development, manufacturing and sales of biomedical materials. Haohai strategically targets the fast-growing therapeutic areas including medical aesthetics, ophthalmology, wound care, orthopedics, and hemostasis. Haohai's dermal filler products include Hyalumatrix, Matrifill and Janlane. Haohai is traded on the Hong Kong and Shanghai stock exchanges.

For Press Inquiries Contact:Megan DriscollEvolveMKD646.285.7165[emailprotected]

SOURCE Eirion Therapeutics, Inc.

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Eirion Therapeutics, Inc. Closes $40 Million Series A Investment and Licensing Deal with Shanghai Haohai Biological Technology Ltd. - PRNewswire

The parking lot at Dodger Stadium in Los Angeles serves as a drive-thru COVID-19 vaccine site open into the night.

By Jon CohenFeb. 16, 2021 , 5:45 PM

SAN DIEGOTwenty days into the new year, cars were entering a parking lot bumper-to-bumper in the shadow of Petco Park, home of the San Diego Padres baseball team. Arms waving, attendants directed the cars into three lines, which split into four more, and yelled as though the first pitch had already been thrown. Im going to load you up, Im sending you 10, you can stack them! one attendant hollered to another.

But the Padres dont play in January.

Instead, Petco Park was home field for this citys drive-thru COVID-19 vaccinations. For 9 days straight, health workers there had been injecting about 5000 people between 7 a.m. and 7 p.m. Run by infectious disease clinician Shira Abeles of UC San Diego Healthdubbed the vaccine czar by the 300 people she manages at the Petco operationit is the citys largest vaccination site, focusing on health care workers and anyone 75 or older. Cars moved through stations where workers checked people in, injected them, and then watched them for at least 15 minutes to make sure they didnt have immediate side effects.

The traffic flow was slow but steadyand no one honked. Above their masks, the visitors eyes were smiling. If vaccine hesitancy has an opposite, this was it.

By the end of January, nearly 100 million people around the world had received COVID-19 vaccines, and more than 1 million were getting shots each day in the United States and China. The effort was lagging in Europe, and staggering global inequities remain. The World Health Organization noted on 5 February that 75% of vaccinations have occurred in 10 countries. About 130 countries had yet to inject anyone with a COVID-19 vaccine. Still, the vaccines, shown in clinical trials to have efficacies of up to 95% against symptomatic disease, have finally given the world the prospect of an escape from COVID-19s long siege. There is so much hope, Abeles says.

Now, as vaccination campaigns gain speed, a raft of pressing questions have arisen: Does being immunized mean you wont spread the virus? When will the campaigns begin to curb the pandemic and allow daily life to return to normal? And what do the new variants of SARS-CoV-2, able to spread faster or evade immune responses, mean for the promise of vaccines? The reality here is this virus is evolving, says Lawrence Corey, a virologist at the University of Washington, Seattle, who co-leads the U.S. governmentsupportednetwork that tests COVID-19 vaccines.

Still, answers are emerging.

One month into the U.S. vaccination campaign, Abeles thinks she has seen its effect already. Beginning in mid-December 2020 some 11,000 UC San Diego Health employees began to receive the Pfizer-BioNTech or the Moderna vaccine, both of which contain messenger RNA (mRNA) that directs the bodys cells to make the surface protein from SARS-CoV-2, spike, to trigger an immune response. Despite reports of health care workers hesitant to get the vaccines, 96% of Abeless colleagues accepted the shots. Each week, those employees are tested for SARS-CoV-2, which exploded in San Diego county starting in December, even if they are feeling healthy.

At the peak, UC San Diego Health was detecting 20 to 30 infections each day in employees, many asymptomatic. By the third week in January, the number had fallen to just a handful. Abeles emphasizes that the evidence is far from conclusive, but says we are extremely hopeful that the link between the drop and the mass vaccination is real.

More compelling, if still preliminary, evidence comes from Israel, home to the worlds most aggressive and best studied immunization campaign so far. A country of 9 million people, Israel has universal health care provided mainly through four HMOs with excellent electronic medical records. The Israeli government negotiated with Pfizer to rapidly roll out its mRNA shots in exchange for sharing data about their impact with the company. Between 19 December and 4 February, 39% of Israelis had received at least one dose of the vaccine. Per capita, that is far higher coverage than in any country other than the similarly small United Arab Emirates (36%).

Nationally, COVID-19 cases and hospitalizations appear to be dropping faster among people 60 or older, the first to receive the vaccines, than among the 40- to 60-year-old segment. And in a 1 February press release, the Maccabi Research and Innovation Centeran arm of one of the four HMOsnoted it had tracked 132,015 of its members over age 60 who had received a vaccine dose in the first 9 days of the immunization campaign. Diagnosed SARS-CoV-2 infections in that group peaked about 10 days after immunizations began. By day 28, when most people had received their second, booster dose, diagnoses had fallen by two-thirds, and COVID-19related hospitalization had dropped from a daily high of seven people to one. In the general population, the team notes, reported cases dropped much more slowly.

Israels aggressive COVID-19 vaccine rollout targeted the elderly first, and an analysis of 132,015people 60 and older who received their initial dose in late December 2020 suggests the shots already started reducing the toll of the pandemic in that country 1 month later.

(Graphic) N. Desai/Science; (Data) Maccabi Research and Innovation Center

That finding constitutes persuasive evidence of real-world benefit of vaccination, especially since prior behavioral restrictions in Israel did not seem to selectively protect those over 60, says Roby Bhattacharyya, an infectious disease specialist at Massachusetts General Hospital.

In the United States, people living in long-term care facilities, most of them elderly, and facilities staff were put at the front of the line for vaccines. Those residents account for about 40% of the countrys COVID-19 deaths, so the impact of vaccinations on their hospitalization and mortality will probably be seen within a month or two, certainly, says Ira Longini, a biostatistician at the University of Florida (UF).

The effect may have already become visible. COVID-19 cases have been dropping nationwide since December, including at nursing homes. Interventions other than vaccines explain some of the fall. But a county-level comparison of facilities that got their first shots from 18 to 27 December and those that didnt showed the drop in daily cases was more than twice as large in the earlier vaccinated facilities (a 48% decline versus 21%).

Blunting COVID-19 cases nationwide is a long game, however, especially in a country such as the United States, where the vaccine rollout has not been as fast or uniform as in Israel. We have a big country. We have a lot of transmission, Longini says. I dont think well see a big impact on numbers of cases from vaccines until the summer.

If vaccines created whats known as sterilizing immunity all the time, no vaccinated person would transmit the virus. Vaccinated grandparents could safely play with their unimmunized grandchildren. Countries could welcome visitors who had proof of vaccination with little fear of introducing new viral variants or reigniting outbreaks.

That level of assurance is a tall order. Few vaccines, for any infectious diseases, create sterilizing immunityeven the most effective ones. The inactivated poliovirus vaccine developed by Jonas Salk did little to block infection or transmission of the virus, yet it powerfully prevented paralytic polio. By 1961, 6 years after it was licensed, only 54% of the U.S. population had received the vaccine, yet paralytic polio cases had dropped by more than 90%.

For practical reasons, the recent COVID-19 vaccine efficacy trials evaluated mainly the frequency of symptomatic disease, typically detected after participants feel sick and get a virus test. Its tougher to identify all SARS-CoV-2 infections, which remain invisible if they dont cause symptoms. Yet models suggest asymptomatic cases account for about half of transmission, so tracking them among vaccine recipients is key. There are easy ways to look at transmission and hard ways, says Ruth Karron, who runs the Johns Hopkins University Center for Immunization Research.

One approach, says John Mascola, who heads the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), is to ask: If youre vaccinated, could you have the virus in your nose and shed it? Thats how researchers studying the AstraZenecaUniversity of Oxford vaccine recently tried to get at transmission. In a U.K. efficacy trial of that vaccine, participants did weekly nasal swabs at home. Results showed vaccination reduced asymptomatic infections by 49.3%. The data suggest, but do not prove, that the vaccine stymies viral spread; misleading news coverage claimed the vaccine had cut transmission by two-thirds. Moderna has also reported a similar decline in asymptomatic infections after just one dose of its mRNA vaccine in a subset of its large efficacy trial, which found overall that the vaccine had 94% efficacy against mild disease.

Several COVID-19 vaccine studies have opted for a simpler, if less precise, look at the issue. They took repeated blood samples from people in both the placebo and vaccinated groups at different time points. The trials tested for antibodies against the viral N protein, which are triggered by infection but not by most vaccines. If the placebo group has more positive N antibody tests than the vaccinated group, that would suggest the vaccine had cut asymptomatic infectionsand therefore transmission. No group has yet reported results from those serosurveys.

Early data from Israel indicate vaccinated people who nevertheless became infected with SARS-CoV-2 have reduced levels of virus, which may make them less contagious. A research team from the Maccabi group and the Israel Institute of Technology measured viral loads in nasal samples taken from more than 1000 people who became infected between 12 to 28 days after their first dose, the period in which immunity begins to build. The amount of virus found was significantly less than in a similar group of unvaccinated, infected Israelis, the group reported on 8 February in a preprint on bioRxiv.

Israel has vaccinated more of its population than any countryand has already seen encouraging drops in COVID-19 cases, hospitalizations, and deaths.

Myron Cohen, an infectious disease clinician at the University of North Carolina, Chapel Hill, and colleagues at the COVID-19 Prevention Network have a proposal at NIAID to study the question in college students. One group would receive the vaccine immediately and a control population would get it weeks later. Both groups of students would swab their noses daily to assess whether there are differences in the rate of asymptomatic SARS-CoV-2 infections and levels of the virus. Withholding vaccine would be ethically dodgy if doses were plentiful, but most college students are still not eligible for vaccination, and they are less likely to develop serious COVID-19 than older adults. Cohen is confident the trial will receive the necessary ethical approvals.

Knowing whether vaccines stop transmission may not matter to government officials. In the next 6 months, were probably going to have a menu of vaccines and each is going to have characteristics related to the cold chain, number of doses required, reactogenicity, and efficacy, Karron notes. Were going to make policy decisions about use based on all of those characteristics. I dont think that some superimprecise measure of transmission is going to be one of the things that goes into our calculus.

But Cohen contends that the difficult studies to evaluate whether immunized people spread the virus are worth doing. Unless we answer this question, we are a masked society. We need to address this to become maskless.

That depends on the definition of normal. To many people now, it means herd immunity, in which a high percentage of a population has either been vaccinated or naturally infected, leaving too few susceptible hosts for a virus to continue to spread. Its such a clean, beautiful concept, the tipping point idea, that if we can just get there, the virus will go away, and then we can just go about our business as if its gone, Longini says. Its kind of a pie-in-the-sky concept thats very, very attractive.

The idea of herd immunity, a term imported from livestock veterinarians, has become more beguiling as huge swaths of populations in parts of the world recover from SARS-CoV-2 infections, leaving them with some degree of immunity. In India, for example, serosurveys have found antibodies to the virus in about half of people in the city of Delhi and the entire state of Karnataka. And though no one is claiming this meets the herd immunity threshold, new cases have recently dropped precipitously.

Still unclear is what percentage of a population needs to be vaccinated or recovered from COVID-19 before herd immunity kicks in. Early predictions were between 60% and 70% and then rose as high as 90%but thats all based on modeling or even guesswork. Anthony Fauci, who heads NIAID, has been taken to task for changing his own estimates. Recently on CNN, Fauci acknowledged that: I think we all have to be honest and humble. Nobody really knows for sure.

Recent developments have been sobering. The COVID-19 vaccines rolling out are highly effective against hospitalization and death, but their success against mild and moderate symptoms plummets when faced with viral variants that can evade vaccine-triggered antibodies. And herd immunity, even if it emerged, could easily fade as immunity waned or new variants arose.

Yet there is growing recognition that even if widespread vaccination cant halt the spread of the virus, it promises a major step back toward normal. Preventing severe disease and death in the elderly and people with comorbidities such as obesity and hypertensionthe most vulnerableis still a resounding victory over the virus, many epidemiologists say.

A nursing home resident in Greece thanks a social worker after receiving a COVID-19 vaccine.

Large swaths of the population might still become infected and develop minor disease or asymptomatic infections. That prospect worries some scientists and clinicians, who note that even mild cases can lead to the long COVID phenomenon of lingering symptoms. Hospitals, though, will not become overwhelmed with emergency cases and deaths will become increasingly rare.

To Corey, those metrics are the most relevant. When will the ICU use and all of this decant so that were at the point where, yes, we can sort of tolerate this? he asks.

Were not going to shut down this virus and end transmission, agrees Nicole Lurie, an adviser to the Coalition for Epidemic Preparedness Innovations. We have to make a decision as a society about how much of this we can and want to live with. Society lives with influenza, after all, which remains endemic despite a vaccine. But Lurie stresses that flu is not an appealing model. It kills up to 60,000 people per year in the United States alonea toll she would not want to accept from COVID-19.

Still, immunologist Brigitte Autran, a member of Frances Scientific Committee on COVID-19 Vaccines, says herd immunity isnt needed to bring back normalcy. The first goal is to have individual protection, and by summing the individual protections, to have a protection of the society that will allow countries to come back to almost real, true lives.

That concern quickly moved from the theoretical to the real world when multicountry studies recently revealed several vaccines were least effective against symptomatic COVID-19 in South Africa. Thats where 95% of infections now stem from a viral variant that in test tube studies could dodge antibodies against the viral spike protein. Novavaxs protein-based vaccine went from 89.3% protection in the United Kingdom, where the variant is rare, to 49.4% in South Africa. And South Africa even halted its planned rollout of the AstraZeneca-Oxford vaccine, which consists of a harmless viral vector carrying the gene for the spike protein, after a small trial there indicated the vaccine had 22% efficacy.

Still, the vaccine-triggered immune responses may retain plenty of muscle, enough to prevent serious symptoms. A third vaccine, from Johnson & Johnson, also fell short against mild disease in South Africa, but it prevented almost all severe diseasewith no hospitalizations or deaths. (The AstraZeneca-Oxford and Novavax studies were too small to address impact on severe disease.)

One explanation could be that the level of key spike antibodies, those capable of neutralizing SARS-CoV-2s infectivity, jumped so high after vaccination that there was a cushion: Even though several labs reported that the variant in South Africa reduced the impact of the vaccine-induced antibodies by up to ninefold, if those immune fighters rise to high enough levels they may still pack enough punch to thwart serious disease.

Other arms of the immune system less affected by the mutations in the variant likely contribute to protection. Pfizer and BioNTech have shown their mRNA vaccine triggers a steep increase in key T cells. One set, which carries the CD8 receptor, targets and destroys cells that SARS-CoV-2 manages to infect. Underscoring the importance of those cells, Pfizer and BioNTech found that even though neutralizing antibody levels triggered by their vaccine were minimal in the 21 days between the first and second doses, it still gave 52.4% protection against disease during that period. Vaccine-induced T cell responses are important for COVID-19 vaccines, particularly for resistant variants that might partially evade neutralizing antibodies, suggests Dan Barouch of Harvard Medical School, whose lab has documented the importance of CD8+ cells for protecting monkeys from coronavirus reinfection.

Mixing and matching COVID-19 vaccines may also boost both antibody and T cell responses to higher levels, creating bigger cushions. Studies of various combinations have begun.

Thats the realm of modelers like Longini. Often, they restrict their analyses to tight geographical areas, which makes it easier to amass high-quality data and to account for variables that can alter outcomes. So Longini and Thomas Hladish, also at UF, created a model for their home state that extrapolates from actual case numbers for COVID-19 and assumes a rapid rollout, starting with people older than 65, of vaccines that are 60% effective at preventing infection. Assuming the virus doesnt change, they found that a vaccination campaign reaching half the population would slash symptomatic disease and death by 30% by August.

Surprisingly, their Florida model shows COVID-19 cases would steadily decline even without vaccination. Thats because the states reproductive number for SARS-CoV-2how many other people each COVID-19 case infectshas dropped below 1. Its mostly masking, social distancing, and the slow buildup of natural immunity in the population, Longini says. Indeed, as in many U.S. states, Floridas cases began to drop steeply in January.

But that decline could quickly reverse if a mutant strain takes off thats 50% more infectious, such as the B.1.1.7 variant strain that exploded first in the United Kingdom and has come to the United States, including Florida. We will have a much bigger epidemic that starts happening now, Longini says. But with more viral spread, the impact of vaccination would be bigger, averting twice as many symptomatic cases and deaths.

Models suggest the impact of COVID-19 vaccinations in San Diego will be blunted by the fast-spreading B.1.1.7 variant, which already accounts for 5% of SARS-CoV-2 infections there. If other prevention efforts are relaxed, a surge of cases will swamp the gains from vaccination.

Swipe or click the arrows to view modeling of other vaccination and behavior scenarios.

(Graphic) N. Desai/Science; (Interactive) K. Franklin/Science; (Data) Kristian Andersen/Scripps Research Institute; Natasha Martin/UC San Diego

Modeler Natasha Martin and her team at the University of California, San Diego, have looked at the interplay of variants and vaccines in an even smaller area: their home county. Sequencing of COVID-19 cases in San Diego county has shown the highly transmissible B.1.1.7 variant has a 5% prevalence so far10 times higher than recently estimated for the nation. Martins model shows that if the variant takes over, as many researchers expect, aggressive vaccination campaigns over the next 3 months will still cut case numbers in half. But if the county drops its guard and people become lax about prevention efforts, COVID-19 cases will triple even with rapid vaccination. We are at a critical moment in the epidemic, where our progress in terms of declining cases could quickly be reversed as the B.1.1.7 strain expands, Martin says. We have the tools we need to fight the spread of this virus: masking, social distancing, vaccination. Now is the time to vaccinate as many people as fast as we can, and double down on masking and distancing.

Vaccine developers proved in 2020 that they can move from concept to candidate vaccine, ready to test in people, in as little as 2 months. Changing the genetic code used in an mRNA or vector-based vaccine, or making a new inactivated-virus preparation, should be at least as fast. (A genetically engineered protein, such as the Novavax vaccine, takes longer.)

But by far the biggest time sink and expense for getting COVID-19 vaccines into use were the large-scale efficacy trials, which took about 4 months. Would those need to be repeated for each updated vaccine? No, says Peter Marks, who heads the vaccine division at the U.S. Food and Drug Administration. All the agency would likely require, he says, is a modest size study in humans showing the immune responses elicited by the new vaccine resemble those triggered by the original and are likely to be protective.

Flu vaccines, after all, are updated yearly to keep up with the ever-morphing influenza virus and are quickly approved. Makers can pop out components from the old vaccine and replace them with new ones. Regulators require minimal evidence about the revised productoften just animal studies showing it performs as well as last years model.

But with COVID-19 vaccines, no one knows which immune responses correlate with protection. Many vaccine experts assume neutralizing antibodies to the spike protein are the most important driver of protection. To prove that, however, researchers need to compare immune responses between vaccinated people infected by viruses that broke through their protection and vaccinated people who did not become infected. A more in-depth sieve analysis of breakthrough cases refines the correlates of protection by looking at the genetics of the variants that break through. Those studies are underway, but the Moderna and Pfizer-BioNTech vaccines, the first approved, worked so well that it was difficult to figure out the protective immune responses. There werent that many vaccinated, infected people, explains Mascola, who is helping coordinate the analyses.

Still, Marks says he anticipates that by the time makers of vaccines formulate new preparations to combat variants and test them in small human studies, the key immune responses will have become clear. We may well have the correlate confirmed by March when it is really needed, he says. That could open the way for rapid approval and rollout of boosters designed to keep up with the evolving virusand ensure that any hard-won progress against the pandemic isnt undone.

Original post:
How soon will COVID-19 vaccines return life to normal? - Science Magazine

When Marie Fuesel was treated for leukemia eight years ago, she needed donated blood products more than 100 times.

Theyd give me my chemotherapy, Id stay in the hospital for a week, then Id go home, get really sick and have to come back in for blood and platelets, says Fuesel, 53, a retired insurance agent who lives in suburban Chicago. I spent over 100 days in the hospital over eight months. The disease and treatments (affect the bone marrow and production of red and white blood cells and platelets), so many transfusions were required to achieve remission.

After eight months of chemotherapy, followed by a year on the targeted drug Sprycel (dasatinib) as part of a clinical trial, Fuesel went into remission. She no longer needs transfusions, but she still appreciates the need for blood donors. I wouldnt be alive if the blood wasnt available when it was needed, she says.

Back then, blood shortages werent common, but they are now. The stay-at-home orders at the beginning of the COVID-19 pandemic forced the cancellation of numerous blood drives, and safety concerns arising from its spread have prompted some frequent donors to stay away from donation centers.

Thats been a source of worry for oncologists. Patients with cancer use nearly one-quarter of the nations blood supply, according to the American Red Cross, and donated blood is a vital resource in the treatment of hematologic cancers. Patients who receive stem cell transplants often need transfusions of oxygen-carrying red blood cells, infection-fighting white blood cells and platelets to control bleeding. Blood transfusions are common in the supportive care of patients undergoing chemotherapy that suppresses production of all the blood cells that results in anemia, because they relieve symptoms that ensue, such as fatigue and shortness of breath.

Between March and June 2020, 37,000 blood drives were canceled, according to the American Red Cross. The impact of the blood shortage varied across the nation but has hit some cities particularly hard. The New York Blood Center, for example, which supplies New York City

hospitals, reported in December 2020 that it had just three days of supply on hand, down from the five- to seven-day supply it normally has.

Ongoing shortages are forcing cancer centers to change some of their procedures for using donated blood. We all recognize that we are in the midst of a public health crisis and that we all have to do our part, says Dr. Mikkael Sekeres, chief of hematology at the University of Miami Miller School of Medicine and a physician liaison in hematology at Sylvester Comprehensive Cancer Center.

In response to COVID-related blood shortages, several cancer centers adjusted their policies for transfusing blood. Moffitt Cancer Center in Tampa, Florida, for example, developed a blood shortage action plan, according to Dr. Kaaron Benson, director of the blood bank at Moffitt. It basically meant dropping some of the thresholds we would normally use for transfusion, Benson says.

Moffitt has not needed to implement the plan yet, but if it does, Benson says, the change would most likely have the biggest effect on patients with leukemia and lymphoma who are given platelets as a preventive strategy. Provided theyre not bleeding or engaging in activities that increase the risk of bleeding, studies have shown you can allow the platelet threshold to drop from our standard of 10,000 per microliter to 5,000, she says.

The technique was first suggested in a 1991 journal article and has since been widely accepted as an appropriate change to make during blood shortages, Benson says.

In recent years, many oncologists have set lower thresholds for red blood cell transfusions another change that has eased the strain on blood supply. They used to routinely order transfusions for patients with hemoglobin levels below 10 grams per deciliter. That number dropped to between 7 and 8 grams per deciliter after a series of studies showed that infusing red blood cells at the higher threshold did not improve treatment outcomes.

During the pandemic, Moffitt and other cancer centers are also delaying some stem cell transplants and elective surgeries, so that blood used during those procedures can be kept on hand for patients who urgently need it, such as trauma patients or those needing emergent surgery. But those decisions are made on a case-by-case basis, so patients should maintain a frequent dialogue with their oncologists to determine the best plan for managing their symptoms during the pandemic.

Patients with multiple myeloma, for example, can benefit from stem cell transplants, but its usually not urgent, says Dr. Stephanie Lee, a hematologist and professor at the Fred Hutchinson Cancer Research Center in Seattle. We have very good treatments for multiple myeloma, so we can continue to give patients chemotherapy for weeks or months, Lee says.

However, she explains, patients with leukemia who need stem cell transplants may be advised to undergo the procedure as quickly as possible, even during the pandemic, because delaying it could cause the cancer to grow and become resistant to treatment.

And some patients with cancer who are simultaneously fighting other diseases should receive all the blood and platelet transfusions they need to manage their cancer, as well as to address any risks posed by chronic conditions. If you have heart disease, and your hemoglobin drops even further, youre more likely to get angina or suffer a heart attack, Sekeres says. So, for those people with serious comorbidities, we are more aggressive in transfusing blood products.

Growing the Donor Pool

Stephenie Perry, who works as the business operations coordinator for the American Red Cross of Northwest Georgia, knows firsthand the value of donated blood. Perry is a survivor of Hodgkin lymphoma who needed several transfusions during her treatment, which consisted of a round of chemotherapy and two stem cell transplants.

Perry, 31, has been in remission since February 2018, but sometimes her red blood cell count still runs low and she needs another blood transfusion. I feel sluggish, and when I stand up, I get really dizzy, says Perry, who lives in Rome, Georgia. When I get a transfusion, its like someone has just given me a shot of energy.

How can patients adapt when blood shortages mandate less frequent transfusions? Lifestyle changes can make a big difference, Sekeres says. If a patient is becoming progressively anemic, and its someone who usually goes for a 2-mile walk every day, maybe theyll reduce it to 1 mile or cut (exercise) altogether, he says.

Some patients may be eligible for iron infusions, which can relieve symptoms of fatigue and lengthen the period between infusions, says Abbey Fueger, clinical trial nurse navigator for the Leukemia & Lymphoma Society.

In addition, there are other small changes that can lessen the risk of anemia and improve symptoms. Some physicians are trying to limit blood draws for patients and recommending nutritional supplements that might help them feel better and lengthen the time between infusions, she says.

Meanwhile, an effort is underway to expand the pool of potential blood donors. In April, the Food and Drug Administration (FDA) addressed blood shortages brought on by COVID-19 by easing up on some of its restrictions on who can donate. For example, people who are at risk of contracting HIV, and those who have a recent tattoo or piercing or possible exposure to an infected individual no longer have to wait one year to give blood. The new waiting period is three months.

The FDA also dropped the waiting period for donors who have traveled to malaria-endemic countries from one year to three months. And it no longer recommends that blood centers turn away donors who lived in certain European countries during the era when Creutzfeldt-Jakob disease, a rare and fatal degenerative brain disorder, was thought to be spreading.

The hospital community is rallying around the cause, holding blood drives of their own and encouraging family members of patients to donate blood.

During the first few months of the pandemic, Fuesel helped put together five small blood drives in her town of Orland Park, Illinois. They were so successful the American Red Cross and a local news broadcaster asked her to help run the seventh annual Great Chicago Blood Drive. So, she did, and on Jan. 13, that event collected 330 units of blood at the Orland Park location and more than 2,000 units at other drives around the city.

For donors who might be nervous about giving blood during a pandemic, Fuesel has a message: Its safe and important. All the beds are spaced apart, and there are different stations when you walk in for getting your temperature checked and using hand sanitizer, Fuesel says. I know these are hard times, but it doesnt cost anything to give your blood. Its a way to help.

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Keep it Flowing: Combating COVID-19 Blood Shortages in Cancer Treatment - Curetoday.com

According to a report from CBS4, doctors in South Florida say an experimental treatment involving stem cells has been successful in treating severe cases of COVID.

The study, which took place at Jackson Memorial Hospital and the University Miami Tower, involved many patients with acute respiratory distress syndrome (ARDS). The groundbreaking treatment, using stem cells from a babys umbilical cord, was shown to safely reduce the risk of death and increase the speed of recovery time faster for some of the studys most ill patients. The FDA approved the trial.

In a double-blind study involving 24 patients with ARDS, each was administered two infusions, given days apart of either the stem cells or a placebo. Researchers discovered that the patient survival rate treated with the stem cells was 91 percent.

Dr. Camillo Ricordi, director of the Cell Transplant Center at the University of Miami Miller School of Medicine, said these stem cells have potential to restore normal immune response and promote tissue regeneration.

When a person develops ARDS, their lungs develop severe inflammation and buildup fluid in their lungs.

Ricordi also said the ARDS patients usually undergo invasive procedures, but that was not the case with this procedure.

Link:
FL Doctors Make Breakthrough Using Stem Cells to Treat ...

Ben Greenfield is a cult figure among fitness fanatics, a guru to the sort of nerds who devote themselves to meticulously monitoring their own biometric data for insight into their personal health. He has more than 50,000 Twitter followers, 60,000 Facebook fans, and 30,000 YouTube subscribes. Now he may become known for something else entirely: Injecting himself with stem cells in hopes that it will make his dick bigger.

I want to take care of my body in the best way possible, Greenfield said during a webinar earlier this month, in which he spoke to listeners while walking on a treadmill. Part of that, he said, means having fun with using what science has given us to make the body better.

Greenfield is something of a human science experiment, whos willing to try almost anything in the name of getting ripped and some publicity. He has subjected himself to platelet-rich plasma injections, stem cell injections, and even sound wave therapy, all in search of bodily enhancement and better health.

I live my life as an N=1, he told Gizmodo, referencing research studies with just one subject.

In November, Greenfield visited U.S. Stem Cell, a controversial clinic in Florida, to have his penis injected with his own stem cells. If the name of the clinic seems familiar, thats because its the same Florida clinic that last year unintentionally blinded three patients in a clinical trial of an unproven stem cell therapy. In August 2017, the Food and Drug Administration sent U.S. Stem Cell and its chief scientific officer Kristin Comella (who appears in the webinar video with Greenfield) a warning letter for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk. U.S. Stem Cell Clinic, the FDA said, even tried to interfere the FDAs investigation by denying agency employees access to facilities. (U.S. Stem Cell did not respond to repeated requests for comment.)

I wanted to go from good to great, and to get a bigger dick, he told Gizmodo. Im not going to lie, thats why guys without erectile dysfunction would do this.

In the webinar, Greenfield and Comella explain how the procedure worked. Greenfield had U.S. Stem Cell isolate stem cells from his bodys fat cells. Then, said Greenfield, those stem cells were injected into the meat of the tissue of his penis. (You dont feel a thing other than a little bit of pressure, he said in the webinar.)

Several early-stage studies have shown that stem cells do show promise in treating erectile dysfunction in men. A press release from U.S. Stem Cell cites one such study from 2016, in which adipose-derived stem cells were used to treat 17 men who suffered from erectile dysfunction after undergoing a radical prostatectomy for prostate cancer. The stem cells were injected at the base of their penis. The men experienced limited side effects, and eight of the 17 men were able to successfully get erections and have sex again. Greenfield, though, was seeking to enhance his manhood, rather than to fix any medical problem. The evidence that such a treatment could help treat erectile troubles is still nascent. Evidence that it could enhance a man without any such issues is even more tenuous.

Kiki Sanford, a molecular physiologist and host of The Stem Cell Podcast, told Gizmodo that while the study cited in the press release suggests the injections might not be harmful, it was also too small of a study to really indicate whether they might actually work, even in men with erectile issues.

You cant say that since a study might have enhanced function in deficient tissue it will do the same in normal tissue, Sanford said. The body doesnt necessarily work that way.

And, she said, even if the procedure is safe there is still risk of complications like infectionall for a procedure that has little chance of working.

Nonetheless, Greenfield said in the webinar that the procedure had made him noticeably better hung.

Three or four days after the procedure, he said, it was almost like it grew. His erections were also bigger, his penis got harder, and his orgasms were better, he said. The better orgasms, he said, might be a placebo effect, but the anatomical changes in size cannot be denied.

Gizmodo asked Greenfield whether he had measured his change in size.

I havent taken out a ruler, he said, explaining that he felt the size fluctuates too much to get a consistent measurement. But he thinks it looks noticeably larger.

When inside of my wife, she can tell, he added.

Greenfield, who considers himself a biohacker, is a big believer in stem cells. Hes had them in his knee and hip to help him recover from an injury, which he said was successful. Hes also injected them into his own arm as a performance enhancer at home. With the help of stem cells, he said, by the time he is 40 in a few years, he hopes to have attained a biological age of 25.

He told Gizmodo that he thoroughly researches any new therapy he plans to undertake, and he felt confident that this one was safe.

There is still a risk, he said. But the payoff in terms of health is very big. You cant always wait for things to be thoroughly studied.

Stem cells do have lots of therapeutic promise. But while most of those treatments are still little more than theoretical, clinics offering stem cell procedures have flourished because FDA regulations allow clinics to inject patients with their own stem cells as long as those cells meet criteria including minimal manipulation and are intended to just perform their normal function. Some treatments, including some of those offered by U.S. Stem Cell, seem to flout those rules, but so far the FDA has had difficulty cracking down. That may change, with a new regulatory initiative announced last fall.

Several US clinics market better sex through stem cell injections to both men and women, for price tags that run more than $1,000.

Stem cell therapies are all very exciting for their potential to help people, but very few have been shown to work well enough in clinical trials to gain FDA approval, said Sanford. We are still very much in the age of snake-oil with respect to many of the therapies that are being marketed, which is too bad because the potential is there.

But why would Greenfield, a fitness guru who says he has no problems with getting it up, want to try a risky, unproven procedure on himself?

Its not normal, he said in the webinar. I dont think ancient man injected stem cells, especially into his nether region.

Then he rattled off a laundry list of modern assailants, including cellphones, and a list of problems including autism and erectile dysfunction that he believes may be related.

Were fighting an uphill battle, he said.

Injecting his penis with stem cells, he continued, is just one way to combat the perils of modern life.

Update, 3:35 p.m., May 5, 2020: This post has been updated to remove a broken video embed.

See the rest here:
This Guy Injected His Dick With Stem Cells to Try to Make ...

Fight the signs of premature aging with these stem cell skin care beauty products. A lot of companies claim to incorporate the benefits of plant and human stem cells, as well as components secreted by them, into the best stem cell beauty products on the market.

Below, we present what appears (based on company claims) to be ten of the best products available today.

As a publisher of stem cell news, we havent traditionally wandered into the world of claims made by stem cell beauty products suppliers. For obvious reasons, we cannot guarantee the accuracy of the claims made by these companies or the presence of specific active agents within them.

However, we get approached daily with questions about this topic and know that people are seeking information about it from a source that: 1) Doesnt inflate the claims, and 2) Understands the science.

For this reason, we have decided to share with you what appear to be interesting skin care options, coupled with a healthy dose of warnings reminding you that the stated claims may or may not be accurate.

Kimera Labs makes the top of this list for numerous reasons. First, the companys science it is solid. Instead of being a supplier of beauty products, the company is a specialty contract research organization (CRO) focusing on regenerative medicine applications, including exosome purification. Exosomes are small vesicles (~30-100nm) that are secreted by nearly all cell types and act as intracellular mail.

Exosomes transfer DNA, RNA, and proteins to other cells, thereby altering the function of the other cells.

Second, the company has an FDA registered tissue facility in Miami, FL, where it develops pharmaceutical grade, exosome-based regenerative therapies. The company has a 6,000 sq. ft. facility in Miramar, Florida, that includes impressive features such asISO:9001/13485 certification, cleanrooms, and a variety of high-end scientific equipment.

Third, the company is run by Dr. Duncan Ross, a highly regarded scientist with a Ph.D. in Immunology from the University of Miami. Dr. Ross is also a Principal at The Kimera Society, a non-profit organization dedicated to the advancementof stem cells, regenerative medicine,and cancer immunotherapies.

For those seeking stem cell beauty products, the companys core offering is XoGlo, a product which provides growth and healing signals to guide the re-deposition of tissue and avoid the scarring that often accompanies burns or other skin damage. You can see an incredible Case Study from the company in which XoGlo was used to heal second-degree burns in a patient in approximately seven days. The product can also be used for general skin health and enhancement.

More information on the XoGlois available here.

According to the company, this facial cleanser is formulated with stem cytokines that promote the skins ability to heal itself, leaving softer and smoother skin. It also has essential fatty acids, detoxifying actives, antioxidants, and anti-inflammatory botanicals that deeply cleanse your skin of excess oil, impurities, and surface debris. This makes the skin smoother, more balanced, and hydrated.

Lifeline says that it offers a moisture serum with a formula consisting of proteins and peptides from pluripotent stem cells. It works by reversing skin aging signs and actively moisturizing the skin with its cucumber melon extracts. The serum primarily targets the reduction of wrinkles and fine lines.

At $105 for a 1 oz bottle, it is notable that the company does not mention how it sources pluripotent stem cells, leaving key questions about its active ingredients unanswered.

Heres another skin care serum on this list of stem cellbeauty products. This serum is enriched with a tissue nutrient solution (TNS) technology that reduces wrinkles and fine lines and improves skin texture and tone. TNS is formulated with matrix proteins, cytokines, soluble collagen, antioxidants, and growth factors that are essential to keeping skin healthy.

This regenerative eye creamcontains autokine-CM obtained from adult stem cells through mini-liposuction. This unique ingredient is composed of extracted cytokines, matrix proteins, and growth factors from adult stem cells that help improve the skins ability to heal. It also aids in synthesizing elastin and collagen production, thus reducing fine lines and wrinkles, improving skin tone and texture, and increasing epidermal thickness in the eye area.

Venus Skin introduced a stem cell therapy serum packed with bio-signals from bone marrow mesenchymal stem cells for stimulation of skin tissue repair and healing. This reverses aging signs and rejuvenates the feel and look of the skin. It also contains essential vitamins A, C, and E to normalize skin functions, promote collagen synthesis in the skin, and reduce the appearance of scars, respectively.

This hydrating mask possesses a stem cell culture technology that penetrates deep into the skin for intense and long-lasting hydration. This leaves the skin well-moisturized and supple. It also fills fine lines and wrinkles and restores parched skin, bringing skin moisture and smoothness back.

This intensive facial mist restores the skins elasticity and moisture with its fine liquid particles that immediately penetrate the skin. It contains APL stem cell-conditioned medium extracts that help regenerate, whiten, and hydrate the skin and minimize pores and wrinkles. The facial mist also has chamomile extracts that bring a soothing effect to the skin.

Skin Drink Phytoceuticals highlights three potent anti-aging skin care ingredients in this serum.PhytoCellTec is an ingredient that safeguards the skin stem cells longevity, fights off skin aging, and delays biological aging of cells. Derm SRC works on reducing wrinkles and fine lines, while Ellagi-C promotes skin elasticity and suppleness.

This snail serum boasts an epidermal growth factor ingredient that stimulates the skins stem cell growth and cell survival. It also has a snail mucus extract that refreshes and brightens the skin. Aside from that, the serum contains other natural ingredients, such as macadamia seed oil and hydrolyzed placenta extract, for skin hydration and nourishment.

Which of these components actually enhance skin health and complexion? Hard to say, but the ingredient list certainly is exotic.

With this list of the best beauty products, it can be tricky to know which ones will enhance skin health. Stem cells are becoming a common ingredient in skin products, but regulation of this area is sparse, making it important to be vigilant in your selection.

A steep price tag doesnt guarantee results. Claims of active ingredients do not guarantee they are present. Even the confirmed presence of an ingredient by third-party testing does not substantiate its claimed effect.

However, there are hundreds of user reviews for some of these products, so the possibility for these skin care products to improve the appearance of your skin does exist. Importantly, many of these stem cell beauty products contain an impressive range of other ingredients, so you could benefit from them due to effects unrelated to the claimed stem cell components.

When judging the efficacy of these products, the only clear answer is that you need to be your own study of one.

Let this infographic be your guide. Download it now and use it as a reference later.

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10 Best Stem Cell Beauty Products On The Market Today