DURHAM, N.C., May. 1, 2015 /PRNewswire-iReach/ -- Stem cells
are a safe therapy for patients with amyotrophic lateral sclerosis
(ALS), according to the results of a recently completed phase 1
clinical trial. Details of the trial, conducted by scientists in
South Korea, are published in this
month's issue of STEM CELLS Translational
Medicine.
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The trial was the next phase of research into stem cells and ALS
being conducted at Hanyang University
and Corestem Inc., both in Seoul,
and Inje University College of Medicine in Busan. ALS is a rapidly progressive,
invariably fatal neurological disease that attacks the motor nerve
cells (neurons) responsible for controlling voluntary muscles.
The HU team's phase 1 trial had two goals: to test whether stem
cells were a safe treatment for ALS, and to learn whether two
injections of the cells might prove more beneficial than a single
injection.
"In our pilot study we followed a group of ALS patients for six
months after giving them a single injection of mesenchymal stromal
cells (MSCs) and found the treatment to be both safe and feasible,"
said the trial's co-leader, Seung Hyun
Kim, Ph.D., director of Hanyang
University (HU) Hospital's Cell Therapy Center and professor
in HU's Department of Neurology. "In this next phase, we wanted to
see if two injections would prove even more beneficial, and we
wanted to follow the participants for a longer period of time to
determine if the treatment proved safe for a longer term than in
the pilot phase."
MSCs, which are found in bone marrow, generate bone, cartilage
and fat cells that support the formation of blood and fibrous
connective tissue. They have emerged as a potentially promising
treatment for ALS due to their ability to regenerate lost or
damaged cells and for their anti-inflammatory capabilities.
Eight patients with definite or probable ALS were enrolled in
the new study, although one died shortly after enrollment. After a
three-month lead-in period, MSCs were isolated from each patient's
bone marrow two times, at an interval of 26 days, with each group
of MSCs then expanded in the lab for 28 days before being injected
into the donor patients. The seven patients received intrathecal
(cerebrospinal fluid space) injections of their own MSCs in two
separate treatments given 26 days apart. Dr. Kim said, "Intrathecal
injections have the advantages of not only avoiding invasive
surgical technique that had been done in the previous other group's
study, but also it's easy to do repeated procedures without harm to
the patients."
Their ALS functional status and safety was then evaluated
for 12 months after the first injection.
"No serious adverse events were observed during this period,"
reported co-leader Ki-Wook Oh, M.D., also of HU's neurology
department. "Additionally, there was no advancement in ALS symptoms
in any of the patients during the 12-month period."
Dr. Kim added, "This study shows that stem cells as a
therapeutic approach for ALS are feasible and well-tolerated at
least for 12 months, supporting the need for a late-stage clinical
trial to examine their in-depth safety, biological effects and
efficacy. Randomized, semi-double blind controlled phase 2
clinical data on 72 ALS patients, which recently was submitted to
the Korean FDA, will be released in the near future."
"The pilot study and this most recent study follow successful
studies in mice showing prolonged lifespan and slowed disease
progression," said Anthony Atala,
M.D., Editor-in-Chief of STEM CELLS Translational
Medicine and director of the Wake Forest Institute for
Regenerative Medicine. "We look forward to seeing the results of
the phase II trial."
The full article, "Phase I Trial of Repeated Intrathecal
Autologous Bone Marrow-derived Mesenchymal Stromal Cells in
Amyotrophic Lateral Sclerosis," can be accessed at:
http://www.stemcellstm.com.
About STEM CELLS Translational Medicine: STEM CELLS
Translational Medicine (SCTM), published by AlphaMed Press, is a
monthly peer-reviewed publication dedicated to significantly
advancing the clinical utilization of stem cell molecular and
cellular biology. By bridging stem cell research and clinical
trials, SCTM will help move applications of these critical
investigations closer to accepted best practices.
About AlphaMed Press: Established in 1983, AlphaMed Press
with offices in Durham, NC,
San Francisco, CA, and
Belfast, Northern Ireland,
publishes two other internationally renowned peer-reviewed
journals: STEM CELLSĀ® (www.StemCells.com), celebrating its
33th year, is the world's first journal devoted to this
fast paced field of research. The OncologistĀ®
(www.TheOncologist.com), also a monthly peer-reviewed publication,
entering its 20th year, is devoted to community and
hospital-based oncologists and physicians entrusted with cancer
patient care. All three journals are premier periodicals with
globally recognized editorial boards dedicated to advancing
knowledge and education in their focused disciplines.
Media Contact: Nick
Lively, AlphaMed Press, 919-680-0011,
nick.lively@alphamedpress.com
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SOURCE STEM CELLS Translational Medicine