ThermoGenesis and TotipotentSC, a US-based medical device company, have received approval from Fortis Escorts' (New Delhi) Independent Ethics Committee, to proceed with a Phase Ib clinical trial in patients suffering from Non-Reconstructable Critical Limb Ischemia (CLI) utilizing ThermoGenesis' Res-Q 60 BMC system.
The trial is designed to assess safety and efficacy of stem cells derived from autologous concentrated bone marrow prepared using the Res-Q system.
The primary endpoints include safety of the cell processing and delivery plus limb salvage rates in 15 patients suffering from the advanced stage of peripheral artery disease.
The Res-Q system is CE-marked in Europe and is an exempt Class I device in the US as a laboratory single use sterile (disposable) bone marrow concentration device.
TotipotentSC’s parent company MK Alliance chairman and CEO Ken Harris said the trial will be conducted at the Escorts Heart Institute in New Delhi, which is part of the Fortis Healthcare network where TotipotentSC has a long term exclusive partnership for advancing the clinical adoption of adult cellular therapies.
ThermoGenesis chairman and CEO Melville Engle said the early experience with the Res-Q in orthopedic procedures has been positive and they believe it will prove to be a valuable tool in treating CLI patients.