Nothing here talks about results, just safety, so followup will be needed
https://www.benzinga.com/pressreleases/18/08/r12276499/long-term-study-shows-endothelial-progenitor-cells-are-safe-for-treati
DURHAM, N.C., Aug. 29, 2018
A new study recently published in STEM CELLS Translational Medicine
demonstrates the long-term safety of laboratory-expanded endothelial
progenitor cells for treating ischemic stroke. This could be good news
for the 15 million people who, according to to the World Stroke
Organization, suffer from this dangerous condition each year.
Ischemic stroke is the most
common type of stroke, affecting nearly 90 percent of all cases. It is
caused by a blocked blood vessel in the brain. In the normal central
nervous system, endothelial progenitor cells (EPCs) play an active role
in building blood vessels. This has led researchers to wonder whether
EPCs circulating in the blood could be recruited after a stroke to
assist in repairing damaged vessels in the brain. However, there is one
major problem with this idea: The number of circulating EPCs is too low
to provide much regenerative capacity – a number that further decreases
in the aging or in those with heart problems.
This makes ex vivo (lab) expanded EPCs an attractive alternative.
"Transplantation of EPCs was
already determined in animal experiments to be a safe and effective
method for treating ischemic stroke. However, their safety and efficacy
had yet to be determined in humans," said Zhenzhou Chen, M.D., Ph.D., Southern Medical University, Guangzhou, China,
and a corresponding author on the study. "In our trial, we tested the
safety and feasibility of transplanting an acute ischemic stroke patient
with his or her own (autologous) ex vivo expanded EPCs."
Eighteen patients were recruited
for the randomized, single-blinded study. Each received conventional
treatment after their stroke then, seven days after symptom onset,
underwent a bone marrow aspiration to collect EPCs and bone marrow
stromal cells (BMSCs) for expansion in the lab. The patients were
divided into three groups and, beginning at week four after the
aspiration, one group was intravenously infused with their own EPCs,
while the other two groups received either their own BMSCs or a saline
placebo as the controls.
Each patient was then monitored for 48 months. Study co-author Xiaodan Jiang,
M.D., Ph.D., also from Southern Medical University, explained, "We
watched for mortality of any cause, adverse events and any new-onset
diseases or conditions. Changes in neurological deficits were also
assessed at different time points."
In the end the researchers found
no toxicity events nor did they see any infusional or allergic
reactions in any of the patients. "The EPC group had less serious
adverse events compared to the placebo-controlled group, although there
were no statistical differences in mortality among the three groups,"
Dr. Chen reported. "Ex vivo expansion always raises concerns that it may
cause instability in the chromosomes or maybe lead to tumors. However,
in our long-term study we observed no increased tumorigenicity. This
safety indicator was also confirmed by many animal studies and other
trials using expanded bone marrow-derived stem cells for treatment of
ischemic stroke."
The researchers did note
limitations in their study, including lack of patient-centered quality
of life outcomes. "Moreover, because of the small size of the cohorts
involved, we could neither identify the neurological or functional
benefits of EPCs on ischemic stroke, nor determine the pros and cons
between EPCs and BMSCs for stroke treatment," Dr. Jiang said. "Thus, we
believe a larger phase 2 trial is warranted."
"This is a promising line of cell therapy research using a novel treatment method that is simple and non-invasive," 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 larger phase 2 trial results."
The full article, "Autologous
endothelial progenitor cells transplantation for acute ischemic stroke: A
four-year follow-up study," 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. SCTM is the official
journal partner of Regenerative Medicine Foundation.
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