Category Archives: Stem Cell Therapy

Published 04 February 2015

International Stem Cell, a California-based biotechnology company developing novel stem cell-based therapies and biomedical products, announced that the company has completed manufacturing of the cell bank of clinical-grade human neural stem cells using its patented process for the recently announced phase 1/2a clinical trial in Parkinson's disease.

The cell bank contains over 2.6 billion human cells, sufficient to meet the company's foreseeable clinical trial requirements.

"Completing the production of clinical-grade cells using the previously published protocol is one of the final steps before starting our clinical program," said Ruslan Semechkin, Ph.D., ISCO's Chief Scientific Officer.

"Because of the complexity involved in manufacturing live human cell products, having our own GMP facility is not only a strategic advantage, but also allows us to control the production costs. We continue to anticipate, subject to regulatory agency approval, beginning the clinical trial in early 2015 and will provide a further update in the near future."

ISCO's master cell bank of human parthenogenetic neural stem cells (ISC-hpNSC) is produced in compliance with current good manufacturing practices (cGMPs) and the chemistry and manufacturing controls (CMC) discussed in the previously reported pre-IND meeting with the FDA. The cells are karyotypically normal hpNSCs and free of measurable contaminants of human or animal origin.

The production of hpNSCs from undifferentiated pluripotent human parthenogenetic stem cells in the master cell bank uses qualified reagents and a standardized protocol developed by ISCO. The undifferentiated human stem cells are derived from the parthenogenetic line and were recently cleared by the FDA for use in clinical trials.

Each batch of hpNSC is subjected to standardized quality control testing to ensure viability, sterility and appropriate cellular composition before clinical use. The existing master cell bank and current production scale are sufficient to supply our anticipated product needs through pivotal clinical trials. The cell bank was produced at the company's state of the art GMP manufacturing facility located in Oceanside, Calif.

ISC-hpNSCs are a novel therapeutic cellular product derived from the Company's proprietary human pluripotent stem cells. Neural stem cells are self-renewing multipotent cells that are precursors for the main cell types of the central nervous system.

The ability of ISC-hpNSCs to differentiate into dopaminergic neurons and express brain-protecting neurotrophic factors offers a new opportunity for the treatment of Parkinson's disease. ISCO's preclinical program includes animal studies to assess the safety and tolerability of our novel cell therapy as well as doses ranging efficacy to be used to design the first clinical trial in Parkinson's disease patients.

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International Stem Cell completes cell bank manufacturing for Parkinson's disease clinical trial

Gordie Howe has made such a dramatic recovery after having stem cell therapy in December in Tijuana, Mexico, that hes heading to Saskatoon, Saskatchewan, this weekend for a dementia fundraiser involving Wayne Gretzky.

The Kinsmen Arena there will be renamed the Gordie Howe Kinsman Arena.

Murray Howe raced from Toledo, Ohio, to Lubbock, Texas, in late October, unsure whether his father, who had suffered a massive stroke, would still be alive when he got there. The Detroit Red Wings hockey legend was being cared for by his daughter, Cathy, and family members were advised to get there quickly if they wanted to see him again.

Murray Howe told the Free Press in a telephone interview Tuesday he was heading back to Lubbock today to help accompany his father, along with other family members, to Saskatoon for the public appearance.

Gordie Howes younger brother, Vic, who played for the New York Rangers, died Saturday at age 85 in Moncton, New Brunswick. Murray Howe said Gordie would not be able to attend his brothers funeral, but would be with two sisters, Helen and Vi, while in Saskatoon, and the family would gather there for a memorial service for their brother.

Although the event in Saskatoon had been planned for more than a year, the Howe family told organizers in August that Gordie probably wouldnt be able to attend because of declining health. They definitely didnt think hed be able to attend following a series of strokes that he had in the months that followed.

But Howe has made a drastic recovery, to the point that family members told the organizers if theres an extra chair for him, he thinks he can make it.

Murray Howe said he was very skeptical when representatives from Stemedica reached out a following the news of Gordie Howes massive stroke.

Stem cells werent even on my radar, Murray Howe said, who did a bunch of research before his father agreed to pursue the therapy.

Stemedica has a stem cell trial in the U.S., but patients have to wait six months following their stroke before they can begin to the therapy. The stem cell trial by Novastem at Clinica Santa Clarita in Mexico did not require a six-month wait.

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Howe to Assist Dementia Fundraiser

When a child is fatally ill with leukemia, a stem cell match can mean restored health and a chance to live.

If the child is Caucasian, there is a reasonable chance a stem cell donor will be found. If the little one is of a different ethnicity, chances are slim.

The sad truth is that if the sick person is in an ethnic group and if no family member matches, then there is a very slim chance of finding a match, even with 20 million people in the registry across the world, Dr. Mohammed Almohammadi said Friday.

The use of stem cells what Almohammadi calls seeds for restored health is increasing for a variety of illnesses, but mainly in blood and marrow diseases like leukemia and lymphoma. The stem cells extracted from a healthy match can help the ill person grow new cells, which often leads to a new lease on life.

Almohammadi, one of the organizers of a registration event Saturday in Halifax, says in some parts of the world, the idea of stem cell therapy seems like a luxury.

There are some places that are fighting disease like Ebola and dont even have registries like this, he said.

We are hoping we can convince more ethnic minorities to become aware of the registry system so that those who need a stem cell donation could have a better chance, he added.

There is a lack of information out there and there are some fears and myths about it but we hope to dispel the myths and increase understanding of how important this is.

All it is is a swab is placed in the mouth and a sample from inside your mouth is taken. Thats all registration is. Its very simple and its sent away and put into a registry so that if someone needs help, you have the choice to help.

Canadian Blood Services is responsible for registering donors in Canada, part of the OneMatch network thats linked to registries around the world.

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More diversity needed for stem cell registry, MD says

Knee problems and stem cell therapy
Dr. Scott Greenberg discusses stem cell procedures for the knee and his experience with athletes, torn meniscus issues, and arthritis.

By: scott greenberg

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Knee problems and stem cell therapy - Video

By Sheryl Ubelacker, The Canadian Press

TORONTO - Two Canadian research centres are gearing up for a clinical trial to determine if a type of stem cell can help alleviate the symptoms of multiple sclerosis.

Researchers at the Ottawa Hospital and Winnipeg's Health Sciences Centre will each recruit 20 MS patients for the trial that will test whether mesenchymal stem cells can reduce inflammation and even help repair damage already caused by the disease.

MS is thought to be an autoimmune disease that creates inflammation in the central nervous system, resulting in injury to myelin, the protective sheath that covers nerves. This damage can create a host of symptoms, leading to varying degrees of physical disability and cognitive impairment.

Mesenchymal stem cells, which are found in bone marrow, fat, skin tissue and umbilical cord blood, have the ability to modify the immune system and reduce inflammation, said neurologist Dr. Mark Freedman of the Ottawa Hospital Research Institute, who is leading the clinical trial.

Freedman said researchers want to determine if these stem cells can demonstrate anti-inflammatory properties in patients with MS.

"But that's not why we're doing it," he said of the study, called MESCAMS ("MEsenchymal Stem cell therapy for CAnadian MS patients"). "We have lots of drugs that can control inflammation in multiple sclerosis that's what all the new medicines do."

"The ultimate hope is that we will be able to exploit some of their other very important biological properties, which is to promote repair."

The two research centres are ready to begin enrolling patients for the trial, which has specific acceptance criteria. While most of those accepted will likely have the relapsing-remitting form of the disease, Freedman said some people with more severe primary- or secondary-progressive MS may also be eligible if they fit the criteria.

The study protocol can be accessed at http://www.clinicaltrials.gov/show/NCT02239393. It will later be posted on the website of the MS Society of Canada, which along with the Multiple Sclerosis Scientific Research Foundation has provided a $4.2-million grant for the study.

Excerpt from:
Trial to test stem cells in MS patients

IMAGE:CDK6 is needed for leukemic stem cell activation (left). When CDK6 is absent, the LSC remains in a quiescent state and leukemia formation is prohibited (right). view more

Credit: Angelika Berger / Vetmeduni Vienna

Despite enormous progress in cancer therapy, many patients still relapse because their treatment addresses the symptoms of the disease rather than the cause, the so-called stem cells. Work in the group of Veronika Sexl at the University of Veterinary Medicine, Vienna has given a tantalizing clue to a solution. In the current issue of Blood, the scientists report that the cell-cycle kinase CDK6 is required for activation of the stem cells responsible for causing leukemia.

Hematopoietic stem cells (HSCs) are normally inactive, i.e. quiescent. When new blood cells are needed, for example to replace blood that has been lost, HSCs start to multiply and develop into mature blood cells. If the process is initiated at an inappropriate time, hematopoietic diseases such as leukemia may result and leukemic stem cells may develop. These represent a major challenge to leukemia therapy: they are quiescent and thus protected from elimination by the immune system and from treatment such as chemotherapy. Leukemic stem cells frequently cause relapse in cancer patients, often years or even decades after an apparently successful treatment.

Working with stem cells isolated from mice, Ruth Scheicher and colleagues at the University of Veterinary Medicine, Vienna have investigated possible differences between leukemic stem cells and the healthy stem cells in the body. They looked in particular at the function of the CDK6 protein, which is known to be involved in controlling the cell cycle. Surprisingly, CDK6 was also found to regulate the activation of hematopoietic and leukemic stem cells, which it does by inhibiting the transcription factor Egr1. Upon loss of CDK6, Egr1 becomes active and prevents stem cells from dividing. In a further twist to the tale, the mechanism operates only when hematopoietic stem cells are stressed, e.g. in leukemia, and not in the normal physiological situation.

Scheicher is quick to note the significance of her finding. "CDK6 is absolutely necessary for leukemic stem cells to induce disease but plays no part in normal hematopoiesis. We thus have a novel opportunity to target leukemia at its origin. Inhibiting CDK6 should attack leukemic stem cells while leaving healthy HSCs unaffected".

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Service: The article 'CDK6 as a key regulator of hematopoietic and leukemic stem cell activation' by Scheicher R, Hoelbl-Kovacic A, Bellutti F, Tigan AS, Prchal-Murphy M, Heller G, Schneckenleithner C, Salazar-Roa M, Zchbauer-Mller S, Zuber J, Malumbres M, Kollmann K and Sexl V. was published in the journal Blood. http://www.bloodjournal.org/content/125/1/90.long?sso-checked=true

About the University of Veterinary Medicine, Vienna

The University of Veterinary Medicine, Vienna in Austria is one of the leading academic and research institutions in the field of Veterinary Sciences in Europe. About 1,300 employees and 2,300 students work on the campus in the north of Vienna which also houses five university clinics and various research sites. Outside of Vienna the university operates Teaching and Research Farms. http://www.vetmeduni.ac.at

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