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Trial Underway Testing Stem Cells for Stroke Repair

Brain model


28 Jan. 2019. A clinical trial assessing stem cell treatments to repair long-term damage to brain cells from a stroke recruited its first patient. Researchers at University of Texas Health Science Center in Houston are leading the study, testing the therapy developed by ReNeuron Group Ltd. in Pencoed, U.K., as well as the site enrolling the participant.

Stroke occurs when blood flow to the brain is interrupted, cutting the oxygen needed by brain cells to function. The vast majority (85%) of strokes are caused by blood clots, while many other strokes are caused by blood vessel leakage in the brain. Nearly 800,000 people in the U.S. have a stroke each year, with paralysis and weakness in the limbs among the results. Recovery, often in rehabilitation clinics, can take months or years of continuous exercises.

ReNeuron develops regenerative stem cell treatments for stroke and the vision disorder retinitis pigmentosa that can be administered directly to patients, without first suppressing the immune system to prevent rejection. The company’s stroke therapy, code-named CTX0E03, derived from neural stem cells and injected into the brain via surgery, is designed for individuals with long-term, but stable neural disability from a stroke. While most treatments aim to arrest brain damage soon after a stroke, there are no therapies designed to repair the damage weeks or months following the stroke, according to ReNeuron.

Sean Savitz, neurology chair at UT Health Sciences Center and the trial’s principal investigator says in a university statement that “Just as in a skin wound, the brain heals in different stages.” Savitz adds, “In animal studies, direct injection in a chronic stroke setting has been shown to improve recovery and outcomes. It appears that the cells are changing the environment of the damaged area of the brain, so it is more pro-regenerative.”

An early-stage trial with 11 men in the U.K. age 60 and over with disability from a stroke, showed CTX0E03 treatments are safe and cause no serious adverse effects. A mid-stage study with 23 individuals in the U.K., also living with disabilities from a stroke, shows after 1 year, 35 percent of participants receiving CTX0E03 report an average gain of 1 point on a 7-point scale of neurological disability. A 1 point gain on the scale is associated with clinically meaningful improvements for the patient, including quality of life, according to the company. In addition, about half of participants beginning the study with some use of their arms, reported gains of more than 1 point on the standard disability scale.

The new clinical trial, also a mid-stage study, is recruiting 110 individuals in the U.S. with persistent disability after 6 to 12 months following a stroke. Participants are randomly assigned to receive CTX0E03 during surgery, or just receive the surgery without CTX0E03. The primary measure of effects from the treatment are changes in the standard neurological disability scale after 6 months, but participants are also assessed on 12 other measures of physical and cognitive disability, as well as reports of adverse effects during that time.

The company says initial results of the trial are expected to be reported early next year.

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