“Latest Stem Cells News”

Emory University researchers are participating in a groundbreaking clinical trial to treat patients with amyotrophic lateral sclerosis (ALS) using human neural stem cells.

The Phase 1 trial, will assess the safety of stem cells, and the surgical procedures and devices required, for multiple injections of the cells directly into the spinal cord.

“This is the first U.S. clinical trial of stem cell injections into the spinal cord for the treatment of ALS,” says principal researcher Jonathan Glass, professor of neurology in the School of Medicin, and director of the Emory ALS Center. “Our main goal in this early phase is to determine whether it is safe to inject stem cells into the spinal cord and whether the cells themselves are safe.”

Three patients with ALS have received injections since the trial began in January. Up to twelve individuals will be enrolled at in this phase of the trial.

Nicholas Boulis, assistant professor of neurosurgery I the School of Medicine and a pioneer in developing surgical methods for delivery of therapeutics to the spinal cord, is performing the surgical procedures.

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Adult stem cells tested for defects before being implanted in the injured spinal cords of mice helped the animals recover with no cancerous side effects, according to new research. In recent years, scientists found that some experimental stem cell therapies can cause cancerous tumors. Pre-screened cells could result in potentially life- saving treatments without such side effects.

These new findings were presented at Neuroscience 2009, the annual meeting of the Society for Neuroscience and the world’s largest source of emerging news about brain science and health. “We tried to identify induced pluripotent stem cells from adult tissue that would be safe when applied to cell therapy for central nervous system disorders,” said Masaya Nakamura, MD, PhD, at Keio University School of Medicine, a co-author of the study. “These results suggest that properly pre-evaluated cells may be a promising source for future transplantation therapy.”

Here, the authors investigated the possibility of making transplantation therapies safer and more efficient by examining different types of stem cells. They generated 36 induced pluripotent stem cell clones, which differed in their origins and other characteristics. They found that the cell’s origin was a crucial indicator of whether the cells would result in tumors.

Results showed that immature (undifferentiated) stem cells are more likely to form tumors than mature ones. The transplantation of “safe” cells into mice with spinal cord injuries resulted in the formation of new neurons, while “unsafe” cells sped recovery for a short period but ultimately formed tumors.

“This study confirms that before human clinical trials go forward involving treatment of central nervous system disorders with induced pluripotent stem cells, pre-evaluating each cell clone carefully is essential,” Nakamura said.

from http://www.sciencedaily.com/releases/2009/10/091022115618.htm

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Researchers and using stem cells as tools for disease study, drug screening, clinical trial strategy, and personalized medicine. The induced Pluripotent Stem cell (iPS) is giving us a chance to rethink the way we are developing new drugs. These iPS cells are usually created from somatic cells (such as skin), and not embryos or adult stem cells. In creating iPS from patients’ diseased cells, scientists can study the disease in vitro, looking for disease phenotypes, applying microenvironmental stress, and testing new drugs. Compared to animal model testing (e.g. mice), this represents a significant breakthrough, that can be used to validate clinical development strategy and test efficacy in specific groups of patients. iPS is bringing a revolution in drug discovery methodology which is being used to bridge genetics, cell biology, and physiology.

from http://biobusiness.tv/videos/208

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Russia’s Stem Cell Institute said on Wednesday it plans to raise up to 165 million roubles ($5.53 million) in what will be the country’s first initial public offering since the financial crisis erupted last year.

If the IPO goes ahead as expected, Stem Cell Institute would have an implied market capitalisation of 825 million roubles.

Stem Cell Institute set an indicative price range of the IPO at between 9 and 11 roubles per ordinary share and the offering will comprise approximately 15 million ordinary shares.

from http://www.reuters.com/article/rbssHealthcareNews/idUSL562611120091007

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On Sept. 14, 46-year-old Hatem Faraj suffered a major heart attack while watching Monday Night Football on TV.
Tuesday, the Wesley Chapel man joined the cutting edge of heart disease research, becoming the area’s first participant in a study to see if a patient’s own stem cells can regenerate his damaged heart muscle.

The procedure he had at Pepin Heart at University Community Hospital in Tampa is part of a University of Florida research program. Its aim is improving chances of long-term survival and reducing heart transplants. Using stem cells to regenerate heart tissue has been studied for several years in animals and humans, producing mixed results. Still, the therapy is considered promising for millions of Americans with heart failure (…)

The most appealing part of the study is that a patient’s own stem cells are used, he said. “It won’t hurt you to participate,” Matar said. “I would encourage physicians to refer their patients.”

Researchers are looking at many questions surrounding the therapy: how many stem cells to infuse into the heart, how long it will take to see results, how soon after a cardiac event should treatment be delivered, how much tissue regeneration can patients expect. The long-term effects of such therapy are unknown.

The University of Florida is one of five U.S. medical centers involved in three federally funded stem cell regeneration clinical trials. Bay area hospitals with cardiac care programs were asked help enroll the almost 300 patients needed for the 2 1/2-year-long study.

“It will be a challenge,” says Dr. Charles Lambert, medical director at Pepin, the first satellite center in Florida to recruit a study participant. Lambert says that’s because patients who have just survived a heart attack must undergo two medical procedures: one to harvest bone marrow in order to get the stem cells, and another to infuse cells in the heart.

Two-thirds of participants will be infused with stem cells; the others will receive a cell-free solution. Patients — including Faraj — won’t know if they actually receive stem cells, standard protocol in medical research (…)

Because it was the first procedure at a satellite center, a UF medical team traveled to Tampa to assist with the bone marrow harvest earlier Tuesday and drive the cells back to Gainesville. There, scientists isolated the heart and vascular stem cells, extracted and purified them and handed them off to a second medical team. They drove the little bag of cells, about six tablespoons worth, back to Tampa.

Faraj was only mildly sedated during the hourlong infusion, in which the stem cells (or a cell-free solution) were sent to his heart through a catheter inserted in the groin and threaded through the femoral artery to his heart. He was smiling and talking with hospital staff immediately afterward (…)

from http://www.tampabay.com/news/health/study-hopes-to-use-patients-own-stem-cells-to-mend-broken-hearts/1041081

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A clampdown on unproven and potentially unsafe stem cell research is being called for by an expert group.
Bionet, a group of expert Chinese and European doctors, lawyers and bioethicists, says countries throughout the world must develop more effective regulation for this emerging science (…)

They had provided a wealth of anecdotal evidence about their concerns that stem cell research was being moved too rapidly into clinical practice without proper study.
He said: “The key is informed consent. Doctors should be able to tell the patient about the short-term and long-term prognosis and the things we don’t know about the risks.”

Bionet is recommending that the safety and efficiency of stem cell treatments is investigated through state-of-the-art clinical trials before they are offered to patients (…)

And there should be quality standards for stem cells used in clinical practice.
These should include the bacterial and viral contamination applied during the production of the stem cells.

China introduced new regulations in May calling for clinical trials before stem cell treatments were offered to patients.
Professor Qui Renzong, vice-president of the ethics committee at the Chinese Ministry of Health, said: “In China there are about 150 institutions now providing stem cell therapy for diabetes through to spinal injuries.” (…)

“When stem cell ‘treatments’ are based overseas, regulatory oversight and jurisdiction is particularly problematic.
We take this very seriously and strongly encourage anyone considering participating in overseas stem cell ‘research trials’ or buying internet treatments to talk to their doctor and follow health guidelines.”

from http://news.bbc.co.uk/2/hi/health/8234206.stm

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