Hadassah stem cell treatment could help MS patients walk again
Not only is there no known cure, but people with progressive MS currently have few if any working treatments.
By Maayan Jaffe-Hoffman, the Jerusalem Post, December 8, 2020
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A magnified view of a CD34+ stem cell. (photo credit: REUTERS) |
An innovative stem cell treatment developed by Hadassah-University Medical Center and NeuroGenesis has led to significant clinical improvements in patients with progressive multiple sclerosis, according to the results of a Phase II clinical trial.
The
results of the placebo-controlled, randomized double-blind trial, which
found that treatment not only halted progression of the disease but led
to improvement in neurological ability, were published in Oxford
University’s peer-reviewed journal Brain.
Multiple sclerosis (MS) is an autoimmune disease that plagues more
than 2.3 million people worldwide, according to the US-based National
Multiple Sclerosis Society. The disease causes damage in the myelin –
the covering that protects the nerves and promotes efficient
transmission of nerve impulses – as well as in the nerve cells of the
central nervous system, ultimately leading to a neurological disability.
People
with MS often experience tingling in their limbs or numbness, can have
trouble walking and using their hands, and eventually can even become
paralyzed. The condition is also associated with visual problems.
To
date, not only is there no known cure, but people with progressive MS
have few if any working treatments. Those that do exist are meant to
reduce the incidence of relapse or marginally slow the progression of
the disease.
Hadassah’s
development, known as NG-01, uses an “autologous proprietary
subpopulation of mesenchymal stem cells.” In layman's terms, the
treatment uses cells derived from the bone marrow of MS patients
themselves, ensuring that there is no element of rejection. The cells
are injected into the spinal cord fluid of the patients’ central nervous
system.
The
cells then travel to the site of injury and create a “repair ecosystem”
in the lesion area, explained NeuroGenesis CEO Tal Gilat.
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| Tal Gilat, CEO, NeuroGenesis (Credit: COURTESY) |
The process is relatively simple and takes about 20 minutes
under local anesthesia. The patient spends a couple of hours in the
hospital for observation and is then free to go home.
The technology was further developed by NeuroGenesis, following a license from Hadasit, Hadassah’s technology transfer company.
“The patients’ improvement was in many cases quite dramatic,” Gilat said.
Nearly
60% of patients did not show any evidence of disease activity during
the entire treatment period, compared to 10% in the placebo group, which
translates to a more than 80% reduction in the progression of the
disease.
Some 20%
of those treated with the stems cells in their spinal fluid showed
improvement after a first injection. After six months, 73% not only did
not experience disease progression but also improved.
Improvements
included a better ability to walk, increased muscle power, neurological
improvements in cognitive function and improvements in the dexterity of
their hands. A functional MRI also showed that there was improvement in
the motor function.
Gilat described patients who could walk again, including one who went from difficulty moving to running 10 miles.
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| Hadassah’s Prof. Dimitrios Karussis (Credit: HADASSAH UNIVERSITY MEDICAL CENTER) |
“Although we currently have several good treatment options for
relapsing remitting MS, we fall short in providing effective treatment
for progressive MS that could substantially suppress the progression of
disability,” said Hadassah’s Prof. Dimitrios Karussis, who led the
study.
“This
trial provides encouraging results and suggests the potential for a new
approach that may not only slow down the progression of the disease but
even induce improvement and promote repair mechanisms in progressive
MS,” he said.
The
Phase II trial involved 48 patients and lasted for three years. However,
some 140 patients have received the treatment, during a Phase I trial
and through compassionate use at Hadassah.
In
none of the studies have there been any serious, treatment-related side
effects. Currently, the results are short term and require continual
treatment to remain effective. Gilat noted that the treatment does not
"deal with the underlying cause of the disease, which is yet unknown. We
are improving the symptoms."
Karussis
added that “on the one hand, we should always be cautious interpreting
positive effects from medium-size studies – and large-scale trials are
needed to confirm these findings.
On
the other hand, when we see such actual neurological improvements in
patients with active and progressive disease, we cannot be restrained
from being enthusiastic,” he said. “These are certainly very strong
findings.”
Gilat
said that Hadassah and NeuroGenesis have also conducted early-stage
trials using the treatment in patients with amyotrophic lateral
sclerosis (ALS) with promising results.
NeuroGenesis
and Hadassah have met with the US Food and Drug Administration and
shared the data from their first trials. Next, they intend to launch a
multicenter Phase III trial in the US, Europe and Israel, and then start
the application process for approval. Karussis estimated that it could
happen in two to five years.
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