Category Archives: Cell Therapy

A US company has revealed it will start tests in an unidentified country in Latin America later this year

ATTEMPTS to bring people back from the dead could start in a few months, its been reported.

A US company has revealed it will start new stem cell therapy trials in an unidentified country in Latin America later this year.

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In the majority of countries, to be officially declared dead requires an complete and irreversible loss of brain function.

But Bioquark says it has developed a series of injections that can reboot the brain and bring people back to life, according to MailOnline.

CEO Ira Pastor revealed the firm will begin testing itsmethod on humans and have no plans to try it out on animals first.

Pastor and orthopaedic surgeon Himanshu Bansal initially hoped to carry out tests in India last year.

Butthe Indian Council of Medical Research pulled the plug on their plans and asked them to to take the trials elsewhere.

In details published on a clinical trials database, scientists plan to examine individuals aged between 15 and 65 who have been declared brain dead from a traumatic brain injury.

They intend to use MRI scans to look for possible signs of brain death reversal before carrying out the trial, which will happen in three stages.

The first step involves harvesting stem cells from the patients own blood before injecting them back into their body.

Then the patient would be given a dose of peptides injected into their spinal cord.

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Lastly they would undergo a 15-day course of laser and median nerve stimulation while monitoring the patient with MRI scans.

Consent is likely to be an issue for the researchers as technically all of the patients will be brain dead.

However the study detail states that it can accept written informed consent from the legally acceptable representative of the patient.

The Bioquark trials are part of a broader project called ReAnima, of which Pastor is on the advisory board.

The project explores the potential of cutting edge biomedical technology for human neuro-regeneration and neuro-reanimation.

Speaking to MailOnline last year, Pastor said: The mission of the ReAnima Project is to focus on clinical research in the state of brain death, or irreversible coma, in subjects who have recently met the Uniform Determination of Death Act criteria, but who are still on cardio-pulmonary or trophic support a classification in many countries around the world known as a living cadaver.

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Scientists set to trial new stem cell therapy to 'reawaken' the brain ... - The Sun

An experimental therapy to repair spinal cord injury with stem cell-derived tissue is progressing smoothly, according to a leader of that trial who spoke at a conference on stem cell therapy.

The Phase 1 safety trial is proceeding with no complications, said Dr. Joseph Ciacci, a University of California San Diego neurosurgeon. The trial is being conducted at the universitys Sanford Stem Cell Clinical Center. The conference was held last week at the Sanford Consortium for Regenerative Medicine in La Jolla.

With safety looking good, the green light has been given to treat more patients, Ciacci said. However, to produce effectiveness, more cells will need to be transplanted.

Four patients have been treated with neural stem cells, injected into the spinal cord. They had experienced complete loss of motor and sensor function below the injury. They had been injured between 1 and 2 years previously.

Moreover, the cells show signs of integrating with the surrounding tissue in animal studies, Ciacci said. If the preliminary evidence holds up, Ciacci and colleagues plan to submit a paper detailing the results.

Curing paralysis from spinal cord injury was a big selling point for those who successfully advocated Proposition 71, which authorized selling $6 billion in state bonds to establish and fund the California Institute for Regenerative Medicine, or CIRM. The institute got $3 billion, the remaining half is going for interest over the life of the bonds.

While CIRM has been under pressure to show results, doctors are taking great care to establish safety first in the spinal cord treatment, because of potential risks in the procedure.

We are now enrolling and recruiting for the second cohort, which is for chronic cervical spinal cord injuries, Ciacci said. They are medically classified as C5-C7 ASIA A Complete.

Chronic injuries need to have taken place more than 1 year before treatment. For this study, the injury must also be under two years old. The trial is being conducted at UCSD with Ciacci serving as the principal investigator.

For more information on the Phase I Chronic SCI study, contact Ciaccis research group at (619) 471-3698, nksidhu@ucsd.edu.

In addition, the researchers have been approved to start another spinal cord injury trial with a different set of cells. These oligodendrocyte progenitor cells, derived from embryonic stem cells, can turn into several different types of neural cells.

The trial, sponsored by Asterias, treats newly injured patients, between 14 and 30 days after injury.

For more information on the Asterias trial, contact the UCSD Alpha Stem Cell Clinic at 858-534-5932 alphastemcellclinic@ucsd.edu or visit http://www.scistar-study.com and j.mp/ucsdast.

Asterias acquired the technology from Geron, which had undertaken the work with a CIRM grant. Geron later canceled the work and refunded the money to CIRM. Asterias got funding from CIRM to continue the work.

The Asterias trial will use the same technique as used with the Chronic SCI trial, a technique which can improve safety, Ciacci said. The cells will be injected in a series of progressively larger amounts that may give evidence of the dose relates to effectiveness, although safety remains the main concern.

This cell line is cryopreserved, its sent to us as a single dose the day of surgery, Ciacci said. Were going to study different doses 2 million, 10 million, 20 million cells per injection. Its going to be a direct injection, just like what weve done before.

As in previous treatments, patients will also receive immune suppression to prevent rejection of the cells. Likewise, they will be monitored for many years after treatment.

Another trial coming to UCSD will test for efficacy in ALS, Ciacci said.

Ciacci said hes looking for qualified patients for these trials, and urged those in the audience to help find them.

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bradley.fikes@sduniontribune.com

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Stem cell-based spinal cord therapy expanded to more patients - The San Diego Union-Tribune

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HICAGO Doctors are reporting unprecedented success from a new cell and gene therapy for multiple myeloma, a blood cancer thats on the rise. Although its early and the study is small 35 people every patient responded and all but two were in some level of remission within two months.

In a second study of nearly two dozen patients, everyone above a certain dose responded.

Experts at an American Society of Clinical Oncology conference in Chicago, where the results were announced Monday, say its a first for multiple myeloma and rare for any cancer treatment to have such success.

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Chemotherapy helps 10 to 30 percent of patients; immune system drugs, 35 to 40 percent at best, and some gene-targeting drugs, 70 to 80 percent, but you dont get to 100, said Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society.

These are impressive results, but time will tell if they last, he said.

Meet the biotech company trying to shake up how the FDA thinks about cancer drugs

Multiple myeloma affects plasma cells, which make antibodies to fight infection. More than 30,000 cases occur each year in the United States, and more than 115,000 worldwide. Its the second fastest growing cancer for men and the third for women, rising 2 to 3 percent per year, according to the National Cancer Institute. About 60,000 to 70,000 Americans have it now.

Nine new drugs have been approved for it since 2000 but theyre not cures; only about half of U.S. patients live five years after diagnosis.

With cell therapy, I cant say we may get a cure, but at least we bring hope of that possibility, said Dr. Frank Fan. He is chief scientific officer of Nanjing Legend Biotech, a Chinese company that tested the treatment with doctors at Xian Jiaotong University.

The treatment, called CAR-T therapy, involves filtering a patients blood to remove immune system soldiers called T cells. These are altered in a lab to contain a gene that targets cancer and then given back to the patient intravenously.

Doctors call it a living drug a one-time treatment to permanently alter cells that multiply in the body into an army to fight cancer. Its shown promise against some leukemias and lymphomas, but this is a new type being tried for multiple myeloma, in patients whose cancer worsened despite many other treatments.

In the Chinese study, 19 of 35 patients are long enough past treatment to judge whether they are in complete remission, and 14 are. The other five had at least a partial remission, with their cancer greatly diminished. Some are more than a year past treatment with no sign of disease.

Most patients had a group of side effects common with this treatment, including fever, low blood pressure, and trouble breathing. Only two cases were severe and all were treatable and temporary, doctors said.

The second study was done in the U.S. by Bluebird Bio and Celgene, using a cell treatment developed by the National Cancer Institute. It tested four different dose levels of cells in a total of 21 patients. Eighteen are long enough from treatment to judge effectiveness, and all 15 who got an adequate amount of cells had a response. Four have reached full remission so far, and some are more than a year past treatment.

The results are very remarkable, not just for how many responded but how well, said Dr. Kenneth Anderson of Dana-Farber Cancer Institute in Boston.

We need to be looking for how long these cells persist and keep the cancer under control, he said.

Dr. Carl June, a University of Pennsylvania researcher who received the conferences top science award for his early work on CAR-T therapy, said its very rare to see everyone respond to a treatment. His lab also had this happen all 22 children testing a new version of CAR-T for leukemia responded, his colleagues reported at the conference.

U.S. could save $825 million a year with a small change in immunotherapy dosing, study says

The first patients we treated in 2010 havent relapsed, June said.

Dr. Michael Sabel of the University of Michigan called the treatment revolutionary.

This is really the epitome of personalized medicine, extending immune therapy to more types of patients, he said.

Legend Biotech plans to continue the study in up to 100 people in China and plans a study in the U.S. early next year. The treatment is expected to cost $200,000 to $300,000, and whos going to pay for that is a big issue, Fan said.

The manufacturing process is very expensive and you cant scale up. Its individualized. You cannot make a batch as is done with a drug, he said.

Nick Leschly, Bluebirds chief executive, said the next phase of his companys study will test what seems the ideal dose in 20 more people.

Marilynn Marchione

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A first: All respond to CAR-T therapy in a blood cancer study - STAT

by Michael Locklear, News 4 San Antonio

Stefanie Cowley of Helotes testified in favor of the bill. She was diagnosed with multiple sclerosis in 2007, was told she was a no-option patient in 2011 and in 2014, she began the therapy that required her to travel to Mexico. (Photo: Sinclair Broadcast Group)

SAN ANTONIO Some terminally and chronically ill patients are eagerly awaiting the governors signature on a bill they believe will help thousands of Texans.

HB 810, known as Charlies Law, would allow access to adult stem cell therapy for certain sick people.

Stefanie Cowley of Helotes testified in favor of the bill. She was diagnosed with multiple sclerosis in 2007, was told she was a no-option patient in 2011 and in 2014, she began the therapy that required her to travel to Mexico.

Cowley said a Houston company, Celltex Therapeutics, does a mini-liposuction, extracting a few tablespoons of her fat, then prepares the hundreds of millions of stem cells. She then travels to Cancun so a private hospital there can set up an hour-long IV to return the stem cells to her body.

These are your healing cells, she said. These are if you cut yourself, they're your healing cells that go towards that spot to repair.

That took my pain levels down from 8-9-10 daily to 2-3-4, Cowley said.

Charlies Law would presumably allow her to access the treatment entirely within Texas, which could become the first state in the country to do so.

Cowley said other conditions such as Parkinsons, Alzheimers and even autism could benefit from the treatment, although stem cell researchers caution that large-scale successes have not yet been reported.

David Eller, CEO and Chairman of Celltex Therapeutics, released the following statement:

@MichaelLocklear | mlocklear@sbgtv.com

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MS patients await governor's signature on bill allowing adult stem ... - WOAI

Stem Cell Therapy is poised to change the face of medicine.

Thousands of published studies and or testimonialscan be wrong! Regeneration or Regenerative Medicine has the ability to change almost all facets of medicine.

Doctors are using them on themselves to help with problems and or provide with a better quality of life, in-fact one doctor sais in a recent stem cell seminar that he would be doing them every year just for preventative maintenance.

Stem Cells have been studied for decades however in the past few years a real breakthrough in using Human UmbilicalCell Tissue (HUCT) being harvested from healthy mommy / healthy baby umbilical cords.

Studies have proved that the older you get the fewer stem cells in the body, ruling out the effectiveness of stem cells extracted from your aging body or your fat.

Statin drugs have been proven to diminishstem cells

Using Concentrated Umbilical-Cord Potentcy Stem Cells (CUP STEM CELLS) give you cell counts in the millions ffrom a newborn tht may allow stem cells to duplicate every 28 hours, over 65 or so cucles making CUP STEM CELLS very favorable to all the other options available in the past.

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Stem Cell Therapy - Checkbiotech.org (press release)

Even as CDMO Lonza deals with FDA concerns about its cell manufacturing operationin the U.S., it has gone out and acquired a gene and cell contract manufacturer in Europe.

Lonza last week said it had acquired Netherlands-based PharmaCell for an undisclosed sum. It said the company had revenues of about 11 million last year. The company has a 15,500 cell manufacturing facility in Maastricht, The Netherlands, which can produce clinical through commercial-scale product.

Lonza said PharmaCell was primarily selected because of its expertise in autologous cell and gene therapy manufacturing, which includes experience with two licensedproducts in Europe.

"PharmaCells position in the market complements Lonzas leadership position in the allogeneic cell manufacturing market," Andreas Weiler, head of emerging technologies at Lonza said in a statement.

Autologous therapies use a patients own cells to create custom products as opposed to allogeneic therapies which can be manufactured in large batches from unrelated donor tissues such as bone marrow which can be used in off-the-shelf therapies. .

Loza said with this deal its gene therapy manufacturing network will span Europe, Asia and the U.S. It is Lonzas U.S. operation in the U.S. that recently ran into FDA concerns. Lonza had its cell therapy facility in Walkersville, Maryland,slapped with a warning letter in April after earlier halting some production of liquid media products being produced for a client.

The plant is overseen by the FDAs devices unit because its products are used for diagnostics. The letter said that retained samples were found to have Pantoea organisms that Lonza discovered after receiving two confirmed complaints for sterility failures of a of product.

A spokesperson said when the warning letter was issued that the company expects to have the problems resolved and FFM media manufacturing back online by mid-2017. The company had already begun a $7.6 million manufacturing upgrade at the facility, which is slated to be finished in 2018.

Excerpt from:
Lonza buys Dutch cell and gene therapy CMO - FiercePharma

"At StemGenex, we are committed to helping people achieve optimum health and better quality of life through the healing benefits of their own stem cells," said Alexander. "Specifically, we use adipose-derived adult stem cell therapy for patients battling conditions such as Multiple Sclerosis, Parkinson's disease, COPD, Rheumatoid Arthritis and Osteoarthritis. We are also committed to the science of stem cell therapy and sponsor five clinical outcome studiesregistered with theNational Institute of Health (NIH) for these diseases."

"What I personally witnessed before the start of StemGenex were patients who had exhausted conventional medical treatments but wanted to try alternative therapies. I was one of them, suffering from severe Rheumatoid Arthritis. Ihad only three options; I could seek a clinical trial, travel to outside of the U.S. to try alternative therapies such as stem cell treatment or petition the FDA for access to drugs under the agency's "expanded access," or "compassionate use" program. Now, new state laws, built on model legislation from the Goldwater Institute in Arizona, will potentially allow doctors and patients to make their own informed decisions on treatments that have cleared the safety phase of FDA testing."

Last year, in a move that was seen by some as a response to Right to Try laws, the 21st Century Cures Act, a landmark piece of legislation focused on medical innovation and medical research, was signed into law by President Obama. This Act provides the FDA with the flexibility to accelerate how it evaluates regenerative medicine treatments, such as stem cell therapies, while maintaining its high standards of safety and efficacy.

"We're on the cusp of a major change on how patients can access stem cell therapy," saidAlexander. "Today, new treatments and advances in research are giving new hope to people affected by a wide range of autoimmune and degenerative illnesses," she said. "StemGenex Medical Group is proud to offer the highest quality of care and to potentially help those with unmet clinical needs improve their quality of life."

ABOUT StemGenex Medical Group StemGenex Medical Group is committed to helping people achieve optimum health and better quality of life through the healing benefits of their own stem cells. StemGenex provides stem cell therapy options for individuals suffering with inflammatory and degenerative illnesses. Committed to the science and innovation of stem cell treatment,StemGenex sponsors five clinical outcome studiesregistered with theNational Institutes of Health ("NIH") for Multiple Sclerosis, Parkinson's Disease, Rheumatoid Arthritis, Chronic Obstructive Pulmonary Disease ("COPD") and Osteoarthritis. These have been established to formally document and evaluate the quality of life changes in individuals following adipose-derived stem cell treatment.

Contact: Jamie Schubert, Director of Media & Community Relations jschubert@StemGenex.com, (858) 242-4243

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/patient-centered-stem-cell-therapy-bill-passed-by-texas-legislature-300465987.html

SOURCE StemGenex Medical Group

https://stemgenex.com/

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Patient-Centered Stem Cell Therapy Bill Passed by Texas Legislature - PR Newswire (press release)

Diabetic patients frequently have lesions on their feet that are very difficult to heal due to poor blood circulation. In cases of serious non-healing infections, a decision to amputate could be made. A new therapeutic approach, presented recently in the Journal of Investigative Dermatology by Canadian researchers affiliated with the University of Montreal Hospital Research Centre (CRCHUM), could prevent these complications by promoting wound healing.

The solution isn't what you might expect, not just another antibiotic ointment or other prescription medication. It's the approach that's different, a way to heal through personalized medicine. "We discovered a way to modify specific white blood cells - the macrophages - and make them capable of accelerating cutaneous healing," explained nephrologist Jean-Franois Cailhier, a CRCHUM researcher and professor at the University of Montreal.

It has long been known that macrophages play a key role in the normal wound healing process. These white cells specialize in major cellular clean-up processes and are essential for tissue repair; they accelerate healing while maintaining a balance between inflammatory and anti-inflammatory reactions (pro-reparation).

"When a wound doesn't heal, it might be secondary to enhanced inflammation and not enough anti-inflammatory activity," explained Cailhier. "We discovered that macrophage behaviour can be controlled so as to tip the balance toward cell repair by means of a special protein called Milk Fat Globule Epidermal Growth Factor-8, or MFG-E8."

Cailhier's team first showed that when there is a skin lesion, MFG-E8 calls for an anti-inflammatory and pro-reparatory reaction in the macrophages. Without this protein, the lesions heal much more slowly. Then the researchers developed a treatment by adoptive cell transfer in order to amplify the healing process.

Adoptive cell transfer consists in treating the patient using his or her own cells, which are harvested, treated, then re-injected in order to exert their action on an organ. This immunotherapeutic strategy is usually used to treat various types of cancer. This is the first time it has been shown to also be useful in reprogramming cells to facilitate healing of the skin.

"We used stem cells derived from murine bone marrow to obtain macrophages, which we treated ex vivo with the MFG-E8 protein before re-injecting them into the mice, and we quickly noticed an acceleration of healing," said Dr. Patrick Laplante, Cailhier's research assistant and first author of the study.

Added Dr. Cailhier, "the MFG-E8 protein, by acting directly upon macrophages, can generate cells that will orchestrate accelerated cutaneous healing."

The beauty of this therapy is that the patient (in this case the mouse) is not exposed to the protein itself. Indeed, as Dr. Cailhier explained, "if we were to inject the MFG-E8 protein directly into the body there could be effects, distant from the wound, upon all the cells that are sensitive to MFG-E8, which could lead to excess repair of the skin causing aberrant scars named keloids. The major advantage [of this treatment] is that we only administer reprogrammed cells, and we find that they are capable of creating the environment needed to accelerate scar formation. We have indeed discovered the unbelievable potential of the macrophage to make healing possible by simple ex vivo treatment."

What now remains to be done is to test this personalized treatment using human cells. Thereafter, the goal will be to develop a program of human cell therapy for diabetic patients and for victims of severe burns. It will take several years of research before this stage can be reached.

This advanced personalized treatment could also make all the difference in treating cases of challenging wounds. According to the World Health Organization, diabetes affects 8.5 percent of the global population, and amputation rates of the lower extremities are 10 to 20 times higher in diabetics. "If, with this treatment, we can succeed in closing wounds and promoting healing of diabetic ulcers, we might be able to avoid amputations," Dr. Cailhier said.

"Serious burn victims could also benefit," he added. "By accelerating and streamlining the healing of burns, we may be able to reduce the infections and keloids that unfortunately develop much too often in such patients." Cancer patients requiring extensive reconstruction surgery could also benefit, he said.

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Healing Wounds with Cell Therapy - Laboratory Equipment

Anew therapeutic approach has been developed which could help prevent diabetes-related amputations, it has been announced.

A team from the University of Montreal Hospital Research Centre (CRCHUM) in Canada say they have found away to modify specific white blood cells the macrophages and make them capable of accelerating cutaneous healing.

It has long been known that macrophages play a key role in the normal wound healing process. These white cells specialise in major cellular clean-up processes and are essential for tissue repair, researchers said.

Jean-Francois Cailhier and Patrick Laplante

CRCHUM nephrologistJean-Francois Cailhiersaid: With this treatment, we can succeed in closing wounds and promoting healing of diabetic ulcers, we might be able to avoid amputations.

When a wound does not heal, it might be secondary to enhanced inflammation and not enough anti-inflammatory activity.We discovered that macrophage behaviour can be controlled so as to tip the balance towards cell repair by means of a special protein called Milk Fat Globule Epidermal Growth Factor-8, or MFG-E8.

During their research, the teamshowed when there is a skin lesion, MFG-E8 calls for an anti-inflammatory and pro-reparatory reaction in the macrophages. Without this protein, the lesions heal much more slowly. Theythen developed a treatment by adoptive cell transfer in order to amplify the healing process.

Adoptive cell transfer consists in treating the patient using theirown cells, which are harvested, treated, then re-injected in order to exert their action on an organ.

Patrick Laplante, research assistant at CRCHUM, said:We used stem cells derived from murine bone marrow to obtain macrophages, which we treated ex vivo with the MFG-E8 protein before re-injecting them into the mice, and we quickly noticed an acceleration of healing.

Dr Cailhier added : If we were to inject the MFG-E8 protein directly into the body there could be effects, distant from the wound, upon all the cells that are sensitive to MFG-E8, which could lead to excess repair of the skin causing aberrant scars named keloids.

The study was published in the Journal of Investigative Dermatology.

In July 2015 Diabetes UK revealedthe number of diabetes-related amputations each week in England had reached an all-time record high of 135.

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New cell therapy could prevent diabetes-related amputations - The ... - The Diabetes Times

Under the terms of this new agreement, PCT will provide GMP-compliant manufacturing services for Orchards lead product, OTL-101

Orchard Therapeutics Limited, a clinical-stage biotechnology company dedicated to bringing transformativeex-vivogene therapies to patients with rare diseases of high unmet medical need recently announced that it has entered a new clinical manufacturing services agreement withPCT Cell Therapy Services, LLC, a Hitachi Group Company.

PCT is a leading provider of contract services for the development and manufacture (CDMO) of cell-based therapeutic and regenerative medicine products. PCT has previously provided a Strategic Manufacturing Assessment (SMA) and manufacturing process development services to Orchard.

Under the terms of this new agreement, PCT will provide GMP-compliant manufacturing services for Orchards lead product, OTL-101, an autologousex-vivogene therapy for the treatment of adenosine deaminase deficiency severe combined immunodeficiency (ADA-SCID).

ADA-SCID is a rare inherited disorder of the immune system caused by mutations in the gene encoding for the enzyme adenosine deaminase, which result in a severe deficiency in white blood cells and life-threatening infections.

Stewart Craig, Ph.D., Orchards Chief Manufacturing Officer commented, We are very pleased to extend our relationship with PCT into a full GMP manufacturing services agreement for OTL-101. As a world-leading CDMO for cell-based therapeutic products, this is an important step in advancing our lead program for the treatment of children afflicted with ADA-SCID.

Robert Preti, Ph.D., Chief Executive Officer and President of PCT said, Expansion of our agreement with Orchard to now include clinical manufacturing in support of their ADA-SCID gene therapy is testament to our successful collaboration and our dedicated stewardship of this important program."

"The clinical results are cause for hope among this patient population and we look forward to helping advance this important new therapeutic towards commercialization., he added

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Orchard Therapeutics Ltd. announces manufacturing services agreement with PCT Cell Therapy Services - BSA bureau (press release)