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Clinical Trial Update: Higher Dosage OK'd as Next Step in PISCES Stroke Trial

PISCES is the world's first fully regulated clinical trial of a neural stem cell therapy for disabled stroke patients. It is taking place in Scotland at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board. The Phase I trial began in late 2010 and is testing the safety of ReN001, a genetically engineered neural stem cell line made by ReNeuron, a UK-based biotech company.

The stem cell therapy is being administered in ascending doses to 12 stroke patients, all men over the age of 60 who were left disabled by an ischaemic stroke, the most common form of the condition. It was previously reported on in STEM CELLS Translational Medicine News in June.

"We are delighted that the DSMB have given a favorable recommendation to proceed to the higher and penultimate dose in the PISCES stroke trial," said Michael Hung, ReNeuron's CEO. "This represents a further important milestone for the study as we make our plans for a subsequent Phase II clinical trial application with ReNeuron's ReN001 cell-based treatment for stroke disability."

The higher dosage will begin with the third of four dose cohorts to be treated in the study. In arriving at its recommendation, the DSMB reviewed safety data from the first two dose cohorts of six patients treated with ReN001.

Of these, two patients are through 18-month followup, one is through 12-month followup, one is through nine-month followup, one is through six-month followup and one is through three-month followup. No cell-related adverse events or adverse immune-related responses have been reported in any of the patients treated to date, and the first patient in this third dose cohort of three patients has been successfully treated with ReN001 and discharged from hospital with no acute safety issues arising, according to the company.

Subject to a continuing lack of cell-related adverse events and affirmative DMSB advice, the remaining patients in the PISCES study will have been recruited and treated by early 2013, ReNeuron reports, leaving the company on track to submit an application for a Phase II clinical study by mid-2013. The remaining patients have already been identified and evaluated as potentially eligible for treatment in the PISCES study, subject to further screening and consenting visits.

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