The Japanese Health Ministry has given conditional approval for a clinical trial using induced pluripotent stem (iPS)-derived myoblast sheets to repair cardiac muscle in patients with severe heart disease, according to reports in the journal Nature.
The trial will assess the safety and feasibility of the technology in three patients with severe ischaemic cardiomyopathy. It is only the second ever clinical application of iPS cells and is generating worldwide interest.
The trial will begin with three people treated over the next year. The team will then seek approval to extend the trial to around 10 patients. If it proves safe, the treatment could then be sold commercially under Japan’s fast-track system for regenerative medicine.
However, some researchers have urged caution about the study. An editorial in Nature has raised concern about the trial’s short timeframe, its patient safety parameters, and the efficacy of the method.
An earlier study by the same team used autologous skeletal myoblast sheets in seven patients with severe chronic heart failure due to ischemic heart disease, approved under the same fast-track system. The trial has yet to provide convincing results, the Nature editorial says.