Another trial

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Another trial

Postby bromley » Fri Nov 23, 2007 1:12 pm

Hadassah uses stem cells for MS, ALS patients

Judy Siegel-Itzkovich , THE JERUSALEM POST Nov. 22, 2007



Neurologists at Jerusalem's Hadassah-University Hospital, Ein Kerem, are the first in the world to help multiple sclerosis (MS) and amyotropic lateral sclerosis (ALS) patients by injecting their spinal columns with large numbers of adult stem cells taken from their bone marrow and multiplied in culture.

The clinical trial, while "encouraging" and "promising," remains highly experimental, as all the patients have undergone a single injection with no untreated control group for comparison. With the first patients having received it two years ago, it is too early to know how successful it will be in the long term.

Prof. Dimitrios Karousis, a senior Greek-born neurologist at Hadassah for the past 19 years, told The Jerusalem Post on Wednesday that the clinical trial was "the first in the world with this type of stem cells." There have been, though, unproven and much-criticized claims of the doubtful scientific value of stem cell injections in desperate MS patients at private clinics in Russia and China.

Karousis added that a hospital in England recently announced that it would soon launch a program for stem cell injections similar to Hadassah's.
Among his collaborators were Prof. Shimon Slavin, the world-renowned stem cell expert at Hadassah who has just retired and moved to Tel Aviv Sourasky Medical Center, and Hadassah neurology department head Prof. Tamir Ben-Hur.

The team first experimented on lab mice with a model of MS and found that after a month or two (a year or two in human time), 90 percent of their neurons remained intact without any breakdown of their myelin sheath, despite the disease. MS and ALS are incurable. One can live with MS for decades, but with growing disability; ALS, however, is usually fatal within a few years.

The researchers received official permission to conduct a small study with 25 patients - nine with MS and 16 with ALS, none of whom responded to conventional drug treatments - from the hospital's Helsinki Committee on Human Medical Experimentation. They are waiting for permission from the Health Ministry's Supreme Helsinki Committee to conduct a much larger study, Karousis said.

The ministry is asking a lot of questions, such as exactly what elements are in the culture medium, he added. In addition to Israelis from various parts of the country, the patients in the trial have come from as far away as the US, South Africa and Italy to get the treatment.

"It is a Phase 1-2 trial, aimed at testing to see how safe it is. While most of the patients' conditions are improved or are stabilized, it's impossible to know how long it will last or how significant the improvement is, as there was no control group," Karousis said. "Yet we are encouraged, as these are patients with advanced cases, many of them in wheelchairs.

There were no side effects so far except for a passing fever or headache." One "dose" of adult stem cells is removed by a needle from the hip bone, then processed and "cleaned" and grown in a special culture. After two months, pure adult stem cells numbering some 50 million are produced and injected into the patient's spinal column. The spinal injection is given only once.

"We are optimistic," said Karousis, "as the use of stem cells is not far into the future. They have already shown some promise in the treatment of joint and bone diseases, immune conditions and ischemia of the heart."
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