UCI researchers investigate use of stem cells to improve recovery of stroke survivors

PISCES III is a phase IIb clinical trial in the U.S. for stroke survivors living with chronic disability

April 18, 2019

Stroke is the fifth leading cause of death, and the leading cause of long-term disability, in the United States. Today, the UC Irvine branch of the UCLA-UCI Alpha Stem Cell Clinic announces 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 research if an investigational drug product (DP), which is made from stem cells, will help improve function in stroke survivors with limited movement in arms and/or legs six to 12 months following an ischemic stroke.

 

PISCES III is a randomized, controlled, phase IIb clinical study in the U.S. to determine if an investigational drug product, called CTX0E03 DP, 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 Dr. Leonid Groysman, principal investigator at UC Irvine. “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.”

 

A previous phase II clinical trial (PISCES II) showed a mRS response rate (> 1-pt improvement from baseline) in 35 percent of ischemic stroke patients at 12 months post-CTX0E03 DP treatment. An even higher mRS response rate (50 percent) 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 following Ischemic 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 percent are ischemic strokes in which blood supply to the brain is blocked.
  • Some stroke survivors recover completely or with minor impairment, but many – 40 percent – experience moderate to severe impairments that require special care.
  • Annual costs for stroke survivors in the United States are estimated to be $34 billion, including health care costs, medications, and lost productivity.

“We are pleased to be involved with this innovative study,” said Groysman, a UCI Health neurologist and assistant clinical professor, Department of Neurology, 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:

www.pisces3.org.

 

About UCLA-UCI Alpha Stem Cell Clinic

The UCLA-UCI Alpha Stem Cell Clinic provides the necessary infrastructure, and medical and operational expertise to effectively and efficiently drive novel stem cell therapies to clinical trials and ultimately change clinical practice. The Alpha Clinics Network funded through CIRM has one unifying goal: to accelerate the development and delivery of stem cell therapies to patients.

 

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

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