Tuesday, 26 March 2013

ReNeuron to begin Phase I stem cell trial on patients with critical limb ischaemia

Reneuron just announced that it has received approval to begin Phase 1 clinical trials with its "ReN009" stem cell-based therapy on people with critical limb ischaemia. The trial will be conducted at the Ninewells Hospital and Medical School in Dundee, Scotland.

According to the press release, the first patients are expected to be enrolled in mid-2013. If the phase I trial goes well it will lead to a larger, placebo-controlled Phase II study in mid-2014. For now, the primary goal of the study is to assess the safety of ReN009 in humans. During the study, 9 patients will receive an intramuscular injection into their affected limb. Jill Belch, from the Institute of Cardiovascular Research, will be the the Principal Investigator. The company may also request approval to enrol patients in a clinical site in Germany.

Michael Hunt, CEO of ReNeuron, said:

“These clinical trial approvals for our next major disease target, together with the recently announced Biomedical Catalyst funding for the Phase I critical limb ischaemia study, represent strong endorsements of the strength of ReNeuron’s technologies and its CTX stem cell therapy candidate. They also represent further significant milestones in the Company’s development into a fully-fledged, clinical-stage stem cell therapy business. We are delighted to be working with Professor Jill Belch on this new clinical trial, a well-respected key opinion leader and highly experienced clinician in the limb ischaemia field.”

Interview with Michael Hunt

ReN009 is an allogeneic, stem cell based therapy aimed for the treatment of critical limb ischaemia. According to Reneuron,  is ReN009 "cost-effective" and works by restoring sufficient blood flow in the affected lower limb.

Critical limb ischemia (CLI) is a term refering to a condition characterized by chronic ischemic at-rest pain, ulcers, or gangrene in one or both legs attributable to objectively proven arterial occlusive disease. CLI occurs in approximately 500 to 1000 per million people per year, with the highest incidences being in older subjects, smokers and diabetics.

You can read the official press release here

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