Stem Cell Therapy to Prevent Strokes Held Up by US Regulator
ReNeuron, a British company developing stem-cell therapies, suffered a setback yesterday when the US food and drug administration (FDA) put the group’s first clinical trial (for strokes in humans) on hold.
The company had filed an application at the beginning of December seeking approval to begin testing its stem-cell therapy for strokes in humans. But the food and drug administration (FDA) had put the study on hold without giving further explanation. The company expects more information when it talks to US officials this week.
The company uses adult stem cells, found in adult tissues, that have the potential to replenish dying cells or regenerate damaged tissues. Its ReN001 stem-cell therapy, for which it submitted the application, is designed to help those left disabled after a stroke.
Moreover the company has developed a technology with which it can grow numerous cell lines from a single tissue sample, meaning it never again needs to use another original sample.
Mr Hunt (CEO) admitted there were political issues surrounding stem cells. But he believed that their application is one that does its best to minimise these ethical considerations.
