December 5, 2011

British MS Study Among Recent Stem Cell Research Successes

British doctors and Bristol University experts are looking to recruit subjects to participate in a trial which could use bone marrow stem cells to halt or possibly even reverse the effects of multiple sclerosis, and it could soon be joined by many other adult stem cell treatments, according to media reports published over the weekend.

According to Telegraph Medical Correspondent Stephen Adams, the UK-based MS trial follows in the footsteps of a pilot study in which six individuals responded positively to the treatment, which involved taking bone marrow from a patient, removing the stem cells, and injecting them into the same person's veins later on in the same day.

"The theory is that the stem cells help repair damage caused to the protective coating of nerve cells, called myelin, which is the cause of MS," Adams wrote, noting that the study was published last year in the journal Clinical Pharmacology and Therapeutics.

The result of that research were described as encouraging, but "showed no actual improvement in disease," the Telegraph reporter added. A larger study was required to prove for sure whether or not the controversial, experimental study -- which is being offered by some medical facilities at a cost of thousands of dollars -- was safe and effective.

Thanks to a donation of more than $1 million from an unnamed U.S. charity, Bristol University and Frenchay Hospital could begin work on that clinical trial as early as February.

If so, it could be the latest success story for adult stem cell-based treatments, some of which are showing early signs of promise and could reach the market within five years, Toni Clarke and Deena Beasley of Reuters wrote on Sunday.

While the data is, for the most part, still in its early stages, more and more positive results are starting to emerge. Progress had been especially positive in the treatment of heart disease and inflammatory conditions, the news agency reporters added, and "pharmaceutical companies are beginning to take note."

"It will only take a few successes to really change the field," Gil Van Bokkelen, chief executive of Athersys Inc. and chairman of the Alliance for Regenerative Medicine, told Clarke and Beasley. "As you see things getting closer and closer to that tipping point, you're going to see a frenzy of activity take place."

"A lot of big companies are looking to place bets on some Phase II products once that data has been confirmed“¦ Even now they're attending all the medical meetings and talking to all the stem cell companies," added Paul Schmitt, managing partner at venture capital firm Novitas Capital, which has invested more than $4 in Amorcyte Inc., a company which is working on a stem cell based treatment for heart disease.

Clarke and Beasley also report on a recent, mid-stage trial conducted by an Australian company known as Mesoblast Ltd. According to their December 4 article, the Mesoblast study has shown that their stem cell products reduces "the rate of heart attacks and the need for artery clearing procedures by 78 percent."

As a result, they have drawn a lot of attention from investors, Reuters says.
"Shire Plc said in May it planned to establish a new regenerative medicine business, and kick-started it with the $750 million purchase of Advanced BioHealing Inc, which makes a skin substitute for treating diabetic foot ulcers," Clarke and Beasley said, adding that "Pfizer Inc, Johnson & Johnson and Roche Holding AG are members of the Alliance for Regenerative Medicine, a nonprofit group that promotes awareness of the field."

However, even if these stem cell based treatments are successful, there are questions as to how they would be regulated both in the U.S. and internationally -- and whether or not they would be approved for clinical use at all.

"Even if companies remain afloat long enough to bring a product through late-stage clinical trials, it is unclear what regulators like the Food and Drug Administration will require in order to approve them," Clarke and Beasley said.

"Some believe the regulatory hurdles for treatments derived from a patient's own cells will be lower than those where the cells come from donors, since there is less risk of cell rejection. However, no clear pathway has yet been established."


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