A new clinical research study at Erlanger Health System NeuroScience Institute is helping neurology specialists determine if stem cells can improve recovery in patients with chronic disability as a result of an ischemic stroke.
“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 Thomas Devlin, MD, PhD principal investigator at Erlanger NeuroScience Institute.
“Currently, the only acute treatments available to stroke patients are within the first three to 24 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.”
The health system’s partnership in the PISCES IIII study involves researching an investigational drug product made from stem cells, CTX0E03 DP, in hopes it will improve function in stroke survivors following a stroke when blood flow to the brain is blocked, such as by a clot. The target population for PISCES III is stroke survivors with some residual arm movement who have stabilized following an ischemic stroke six to 24 months prior to treatment, but who still have moderate or moderately severe disability requiring help from others to carry out activities of daily living.
PISCES III is a randomized, controlled, phase IIb clinical study in the United States to determine if the drug product 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 one-point improvement from baseline is considered clinically meaningful as it represents a stroke survivor’s ability to function more independently.
A previous phase II clinical trial (PISCES II) showed a mRS response rate (> one-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.
“We are pleased to be involved with this study,” said Dr. Devlin. “Results from PISCES III may offer a new treatment approach for ischemic stroke survivors with long-term disability.”
Facts about Ischemic Stroke
- Stroke is the fifth leading cause of death.
- Stroke is the leading cause of long-term disability in the United States.
- Nearly 800,000 people in the United States 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 - 40 percent experience moderate to severe impairments that require specialized care.
- Annual costs for stroke survivors in the United States are estimated to be $34 billion, including health care costs, medications and lost productivity.
To learn more about this trial and/or determine eligibility, visit the PISCES III trial website: www.pisces3.org
Additional information about the study can be found at clinicaltrials.gov
using the identifier NCT03629275..