Stem cells against stroke: clinical studies and bureaucratic barriers
The world's first study of stem cell therapy in stroke patients will be conducted in Britain
Natalia Pankratova, Farmvestnik, according to Reuters: UPDATE 1-UK firm gets final green light for stem cell trialThe British biotech company ReNeuron and a group of Scottish doctors have received final permission to conduct a clinical trial aimed at finding out whether stem cell therapy can help stroke patients.
The resolution of the British Advisory Committee on Gene Therapy (GTAC) was preceded by months of delays and questions. The fact is that the study is the first experiment of its kind in the world. ReNeuron received approval from the national regulatory authority back in January 2009, but before starting a Phase I clinical trial, it was necessary to obtain a GTAC recommendation.
It is expected that the first patient will receive the new therapy through the State Health Service at the Southern Hospital at the Institute of Neurological Sciences (Glasgow) during the second quarter of this year. In total, 12 patients who have had from 6 to 24 months since the ischemic stroke will receive therapy using ReN001 stem cells. The treatment process involves the direct injection of millions of cells into the affected part of the brain. The patients will be monitored for 2 years.
If the first study is successful, the scientists plan to accelerate the preparation and conduct of clinical trials of the last phase, focusing first on patients with more severe consequences of stroke.
ReNeuron initially hoped to conduct research in the United States, but in 2008 focused its efforts on obtaining permission in Britain after the FDA delayed a decision.
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