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Newswise CAMBRIDGE, Mass. (November 6, 2014) Induced neural stem cells (iNSCs) created from adult cells hold promise for therapeutic transplantation, but their potential in this capacity has been limited by failed efforts to maintain such cells in the desirable multi-potent NSC state without continuous expression of the transcription factors used initially to reprogram them.

Now, Whitehead Institute scientists have created iNSCs that remain in the multi-potent state without ongoing expression of reprogramming factors. This allows the iNSCs to divide repeatedly to generate cells in quantities sufficient for therapy.

Therapeutically, its important to make neural stem cells because they can self-renew and make lots of cells, says Whitehead Institute Founding Member Rudolf Jaenisch, who is also a professor of biology at MIT. If you just make mature neurons, which has been done by others, you never get enough cells.

To make iNSCs via direct lineage conversion researchers use viruses to insert a cocktail of transcription factors into the genome of mouse adult skin cells. A drug triggers these transcription factors to turn on genes active in neural stem cells. This direct conversion, known as transdifferentiation, bypasses the step of pushing the cells first through an embryonic stem-cell-like state.

In previous research, iNSCs remained addicted to the drug and reprogramming transcription factors; if either the drug or the factors was removed, the cells reverted to skin cells or spontaneously differentiated.

If the reprogramming factors are still active, its horrible for the cells, says John Cassady, a scientist in Jaenischs lab. The cells would be unable to differentiate and the resulting cells would not be therapeutically useful.

In a paper published online this week in the current issue of the journal Stem Cell Reports, Cassady and other Whitehead scientists describe how they preserve the cells properties without keeping the reprogramming factors active. First, the cells were grown in a special medium that selects for neural stem cells. Then, the drug is removed. Instead of spontaneously differentiating, the iNSCs remain in a multi-potent state that can differentiate into neurons and glia cells on cue. Cassady also refined the reprogramming cocktail to contain eight transcription factors, which produces iNSCs that are transcriptionally and epigenetically similar to mouse neural stem cells.

Cassady notes that a random sample of skin cells can contain neural crest cells, which may more easily make the transition to iNSCs. To eliminate the possibility that his method might actually rely on cells having this sort of head start, Cassady converted fully mature immune system cells called B-lymphocytes, which have a very specific genetic marker, to iNSCs. The resulting cells had the profile of their new identity as iNSCs, yet retained their B-lymphocyte genetic marker, showing that Cassadys method could indeed convert non-neural cells to iNSCs.

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Direct Generation of Neural Stem Cells Could Enable Transplantation Therapy

Freeport, Grand Bahama (PRWEB) November 05, 2014

Okyanos is the first to receive regulatory approval from the National Stem Cell Ethics Committee (NSEC) to provide adult stem cell therapy in its new state-of-the-art facility and has now begun treating patients. The licensing includes approval for cardiac cell therapy, as well as cell therapy for tissue ischemia, autoimmune diseases, and other chronic neurological and orthopedic conditions. The licensing criteria requires that approved protocols be supported by peer-reviewed papers showing substantial evidence of safety and efficacy.

"As the leader in cell therapy, Okyanos is very proud to bring a new standard of care and a better quality of life to patients who are looking for new options for unmet healthcare needs. said Matt Feshbach, CEO and co-founder of Okyanos. Adipose (fat)- derived stem and regenerative cells (ADRCs) are known to restore blood flow, modulate the immune system, reduce inflammation and prevent further cell death after a wound, helping the body begin the process of healing itself.

Adult stem cell therapy has emerged as a new treatment alternative for those who want to live a more normal life but are restricted in these activities due to their medical conditions. Just 50 miles from the US shore, Okyanos cell therapy is available to patients with severe heart disease including coronary artery disease (CAD) and congestive heart failure (CHF) as well as patients with auto-immune diseases, orthopedic, neurological and urological conditions. Okyanos cell therapy is performed in their new state-of-the-art facility built to exceed U.S. surgical center standards.

With the regulatory and licensing approvals for adult stem cell therapy, Okyanos is the first to treat patients with cell therapy for severe heart disease and other unmet medical conditions based on a combination of internationally approved cell processing technology, technical papers, clinical trials and in-clinic use which provide the basis for a new standard of care.

Patients can contact Okyanos at http://www.okyanos.com or by calling toll free at 1-855-659-2667.

About Okyanos: (Oh key AH nos) Based in Freeport, Grand Bahama, Okyanos brings a new standard of care and a better quality of life to patients with coronary artery disease, tissue ischemia, autoimmune diseases, and other chronic neurological and orthopedic conditions. Okyanos Cell Therapy utilizes a unique blend of stem and regenerative cells derived from patients own adipose (fat) tissue which helps improve blood flow, moderate destructive immune response and prevent further cell death. Okyanos is fully licensed under the Bahamas Stem Cell Therapy and Research Act and adheres to U.S. surgical center standards. The literary name Okyanos, the Greek god of the river Okyanos, symbolizes restoration of blood flow.

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Okyanos Treats First Patients with Cell Therapy

International Stem Cell Corp., a Carlsbad-based biotech company developing stem cell therapies and biomedical products, announced that the U. S. Food and Drug Administration has cleared the companys human parthenogenetic stem cell line for investigational clinical use.

Human embryonic stem cells typically come from fertilized eggs. In 2007, however, scientists at International Stem Cell Corp. (ISCO) reported the first successful creation of human stem cell lines from unfertilized eggs, according to Scientific American. They used a process called parthenogenesis, in which researchers use chemicals to induce the egg to begin developing as if it had been fertilized. The egg called a parthenote behaves just like an embryo in the early stages of division. Because it contains no genetic material from a father, however, it cannot develop into a viable fetus. Just like embryonic stem cells, parthenogenetic stem cells can be coaxed to grow into different kinds of human cells or tissue, ready to be transplanted into diseased areas of the body.

"Many stem cell lines can never be used to develop commercial therapeutic products because they don't meet the FDA's ethical and quality standards, said Ruslan Semechkin, ISCOs chief scientific officer. With this clearance from the FDA, based on the safety of our cells and quality of our manufacturing processes, the company has removed any uncertainty in the potential clinical use of human parthenogenetic stem cells. Not only does this increase the chance that our regulatory submission for the treatment of Parkinson's disease, which we will be submitting before the end of the year, will be approved, but it also means that our human parthenogenetic stem cells can serve as the basis for investigational clinical studies for other indications, for example stroke or traumatic brain injury."

To be approved by the FDA for use in human trials and commercial therapeutic products, stem cells must be grown under what's known as good manufacturing practice (GMP) conditions. GMP standards require that each batch of cells is grown in identical, repeatable conditions, ensuring that they have the same properties, and each person receiving a stem cell therapy would be getting an equivalent treatment. According to ISCO, achieving this level of consistency is difficult and requires knowing the exact identity and quantity of every component of the media that the cells grow in and characterizing cell batches extremely precisely, as well as rigorous quality control and assurance.

ISCO (OTCQB: ISCO) will use its own GMP facilities in Oceanside to produce the cells in preparation for the first clinical trial.

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International Stem Cell Corp. Gets FDA Clearance

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Stem Cell Therapy BACKSTAGE

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Stem Cell Therapy BACKSTAGE - Video

Jeanne Loring holds a petri dish with induced pluripotent stem cells from a Parkinsons patient.

The U.S. Supreme Court will be asked to intervene over a controversial embryonic stem cell patent, opponents of the patent said Thursday.

Jeanne Loring, a stem cell scientist at The Scripps Research Institute, said the court will be asked Friday to overturn a lower court decision and allow the opponents to seek cancellation of the patent held by the Wisconsin Alumni Research Foundation, or WARF.

Loring and two public interest groups, Consumer Watchdog and the Public Patent Foundation, have been trying to get that patent overturned since 2006. Another patent giving rights over induced pluripotent stem cells has been waived by WARF.

Loring, who is researching the use of induced pluripotent stem cells to treat Parkinson's disease, said the remaining patent impedes development of embryonic stem cell therapies.

Embryonic stem cell therapies are reaching the clinical stage, such as San Diego's ViaCyte, which recently began trials of its therapy for Type 1 diabetes, derived from human embryonic stem cells.

"We think that now embryonic stem cells really are showing their worth in clinical studies, it's very important to just wipe this thing off the books, so nobody can either shut down trials or require huge licensing fees for successful efforts," Loring said.

The foundation got the patent for work by James Thomson of the University of Wisconsin-Madison. He was the first to derive human embryonic stem cells, in 1998.

Opponents say Thomson's feat, while significant, was not a patent-worthy technological advance. Loring has said other qualified scientists could have isolated the cells with methods used for finding animal embryonic stem cells, so the advance was obvious.

Moreover, embryonic stem cells are a product of nature and therefore not patentable according to a 2012 Supreme Court ruling, they say.

Read this article:
Stem cell patent to reach Supreme Court

Irelands first human stem cell trial using lab-grown cells is due to get underway in Galway in the new year following approval from the medicines watchdog.

The trial will involve extracting adult mesenchymal stem cells (MSC) from the bone marrow of patients with a condition known as critical limb ischemia (CLI) a severe blockage of the arteries resulting in marked reduction in blood flow to the extremities.

Reduction in blood flow to the legs puts patients at risk of gangrene, ulceration, and amputation, and the Galway trial will look at the use of MSCs to grow new stems cells which will then be injected back into the patients leg with the hope of growing new blood cells and improving circulation.

The harvested stem cells will be grown to much greater quantities in a highly specialised lab before being injected back into the patients leg.

Tim OBrien, director of the Galway-based Regenerative Medicine Institute, said their research was focused on whether MSC therapy could improve blood flow to the legs in patients with CLI a condition common in diabetics and therefore avoid the need for amputation. The trial is aimed predominantly at testing the safety and feasibility of what is very much an experimental therapy, Prof OBrien said.

We will be doing a dose escalation study, with some patients given a small dose, others a medium dose and the remainder a high dose, he said. We want to try and establish how many cells do you need to give a patient.

The study, the first in humans in Ireland, will be a year-long study involving nine patients. Prof OBrien said they would not be advertising for participants, but rather would let clinicians know and await referrals of suitable patients.

In the meantime, they would be preparing the custom-built facility where the cells are grown, at the Centre for Cell Manufacturing Ireland in NUI Galway, the first such facility in Ireland to receive a licence from the Health Products Regulatory Authority.

Prof OBrien said MSCs have a lot of properties that may make them useful in treating a wide variety of disease because of their reparative and regenerative qualities.

Prof OBrien delivered a talk yesterday on the Therapeutic Potential of MSCs in Diabetic Complications on the second day of a two-day international stem cell conference at NUI Galway.

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Lab-grown stem cell trial gets green light