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Stem cell therapy for stroke patients gets closer

22nd September 2005

A company in the United States has held a formal meeting with the US Food and Drug Administration (FDA) to discuss its stem cell therapy to treat chronic disability after stroke.

The ReNeuron Group has announced it attended the meeting in July with members of the FDA's evaluation of biologics unit CBER to discuss the ReN001 programme.

The company has now received the minutes from that meeting and are now maintaining pre-clinical development timelines for its ReN001 stroke programme.

This means that if the pre-clinical testing of the therapy is successful, the company will apply to commence initial clinical trials with the FDA by mid-next year.

ReNeuron is also applying to the regulatory bodies in the UK and Europe.

Chief executive officer of ReNeuron Michael Hunt said: "ReNeuron's ReN001 stem cell therapy for stroke is a pioneering development programme, and therefore one where we believe collaboration between ReNeuron and the regulatory authorities is critical in defining the safety and performance criteria for the therapy.

"We are grateful to the CBER team for their constructive comments and assistance in helping the company to define the most appropriate development strategy for ReN001, and we look forward to further positive interaction with CBER and the regulatory authorities in Europe as ReN001 progresses towards the clinic."

If successful it is believed ReN0001 would be the world's first clinical-stage neural stem cell therapy for stroke patients.