UCI researchers test stem cells to improve recovery of stroke survivors
PISCES III is a phase 2b clinical trial to improve mobility after an ischemic stroke
April 18, 2019
Stroke is the fifth leading cause of death, and the leading cause of long-term disability, in the United States. The UCI Alpha Stem Cell Clinic (ASCC) has announced its participation in a new clinical research study that aims to improve function in people with chronic disability as a result of an ischemic stroke — a stroke that occurs when blood flow to the brain is blocked, such as by a clot.
The study, called PISCES III, will determine whether an investigational drug product (DP) made from stem cells can improve function in stroke survivors who have limited movement in arms and/or legs for six to 12 months following an ischemic stroke.
PISCES III is a randomized, controlled, phase 2b clinical study of CTX0E03 DP to test whether it can change the degree of dependency and disability in ischemic stroke survivors as measured by the modified Rankin Scale (mRS) six months post- treatment as compared to baseline. The mRS is a 7-point, clinician-reported global measure of disability or dependence upon others in carrying out activities of daily living. A 1-point improvement from baseline is considered clinically meaningful as it represents a stroke survivor’s ability to function more independently.
“Post-stroke disability is a major public health issue, with nearly one-half of all stroke survivors left with permanent disabilities as a result of damage to the brain,” said UCI Health neurologist Dr. Leonid Groysman, principal investigator at ASCC, the clinical arm of the UCI Sue & Bill Gross Stem Cell Center.
“Currently, the only acute treatments available to stroke patients are within the first three to six hours following the stroke. Beyond this acute phase, there are no existing treatments, aside from rehabilitative treatments, to alleviate the disabilities suffered by stroke patients,” Groysman said.
A previous phase 2 clinical trial, called PISCES II, showed a mRS response rate (> 1-pt improvement from baseline) in 35% of ischemic stroke patients at 12 months post-CTX0E03 DP treatment. An even higher mRS response rate (50%) was measured at 12 months post-CTX0E03 DP treatment in ischemic stroke patients who had some residual arm movement at baseline.
The target population for PISCES III will be stroke survivors with some residual arm movement, who have stabilized following an ischemic stroke six to 12 months prior to treatment, but who still have moderate or moderately severe disability (a mRS score of either 3 or 4) requiring help from others to carry out activities of daily living.
Why study functional recovery after a stroke?
- Stroke is the leading cause of long-term disability in the United States.
- Nearly 800,000 people in the U.S. have a stroke each year — 87% are ischemic strokes, in which blood supply to the brain is blocked.
- Some stroke survivors recover completely or with minor impairment, but many — 40% — experience moderate to severe impairments that require special care.
- Annual costs for U.S. stroke survivors are estimated at $34 billion, which includes healthcare costs, medications and lost productivity.
“We are pleased to be involved with this innovative study,” said Groysman, who also is an assistant professor of neurology at the UCI School of Medicine. “Results from PISCES III may offer a new treatment approach for ischemic stroke survivors with long-term disability.”
PISCES III is funded by ReNeuron Ltd., a leading, clinical stage, stem-cell company based in the United Kingdom with U.S. offices in the New England area. To learn more about this trial and/or determine eligibility, visit the PISCES III trial website at www.pisces3.org
Additional information about the study can be found at clinicaltrials.gov using the identifier NCT03629275 and at www.pisces3.org ›
References:
UCI IRB Approved: 03-15-2019 | MOD# 25806 | HS# 2018-4779
The UCI Alpha Stem Cell Clinic (ASCC) is the clinical trials arm of the UCI Sue & Bill Gross Stem Cell Research Center (SCRC) and part of a network of the state's leading medical centers funded by the California Institute of Regenerative Medicine (CIRM). The ASCC specializes in delivering leading-edge stem cell clinical trials to patients and seeks to accelerate the development of treatments through partnerships with patients, medical providers and clinical trial sponsors. The ASCC network supports both CIRM-funded clinical trials and those funded by academic and industry sponsors. Visit www.stemcell.uci.edu to learn more about ASCC, clinical stem cell trials and regenerative medicine research at UCI.