Preliminary
analysis of FDA-approved study conducted by the Tisch MS Research Centerof New York found that stem cell treatments substantially improved muscle
strength and disability scores, particularly among patients with lower levels of
disability
New York, NY – April 13, 2022 – New
research conducted by the Tisch MS Research Center of New York has found that
multiple stem cell treatments
may result in substantial improvement
in muscle strength of MS patients. According to a preliminary analysis
of results from the FDA-approved study, these stem cell treatments
are the first-ever treatments that improve neurological outcomes in secondary
progressive MS (SPMS) and primary progressive MS (PPMS) patients.
At the onset of the study, researchers
calculated each patient’s universally-accepted disability scale (EDSS score),
which was measured before their first treatment and again after their sixth
stem cell treatment. All patients had an EDSS score between 3 and 6.5, with
patients at a score of 3 able to walk well (despite some muscle weakness), and
patients at a 6 or 6.5 requiring assistive devices to ambulate. At the onset of
the treatments, 60% of patients had an EDSS score of less than 6, while 40% had
a score of 6 or 6.5 and required
either a cane or walker to ambulate.
Following the stem cell treatments,
upper limb dexterity and walking speed improved for 36% of patients, while 30%
noted improved muscle strength. While the patient’s age and type of MS did not
impact treatment response, level of disability at the start of the study was
the most important clinical determinant of a patient’s outcome. In fact, for
patients with an EDSS score below 6 before the trial, 58% saw improved muscle
strength, and 52% had improved disability scores (EDSS) whereas less than 10%
of patients with an EDSS score 6 or above showed improvement.
“This study has found, for the first
time ever, a treatment that’s successful in reversing established disabilities
in patients who are in the early stages of Secondary Progressive and Primary
Progressive MS,” said Dr. Saud A. Sadiq, Director and Chief Research Scientist
at the Tisch MS Research Center of
New York.
“These findings are unprecedented for
the treatment of MS patients. While in the past patients could have experienced
loss of mobility and muscle strength each year due to their MS, this stem cell
treatment has opened the possibility that such life-altering symptoms may not
occur at all if the treatment is administered early in their disease
progression. Furthermore, this study also has potential implications as a
therapy for other neurological diseases in the future,” Dr. Sadiq added.
The study is an FDA-approved, phase
II, double-blind, placebo-controlled crossover-study involving 50 total
patients – including 40 with SPMS and 10 with PPMS. The
analysis encompasses 36 patients, all of whom have completed six stem cell
treatments.
All 50 patients will receive either
six placebo or six stem cell treatments, injected at two-month intervals for a
year, and then receive the reciprocal treatment in the following year. A
complete statistical analysis of this study will be done shortly after the
trial is completed at the end of 2022.
About the Tisch MS Research Center of
New York
The mission of the Tisch Multiple
Sclerosis Research Center of New York is to conduct groundbreaking medical
research to ensure unparalleled care and positive outcomes for MS patients. Its
integrated relationship with the International Multiple Sclerosis Management
Practice (IMSMP) accelerates the pace at which research discoveries translate
from lab bench to bedside. The Center aims to identify the cause of MS,
understand disease mechanisms, optimize therapies, and repair the damage caused
by MS while offering patients access to the best and most advanced treatments
possible.
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