US-based cell-based regenerative medicine company Cesca Therapeutics has reported positive 40-month follow-up results from the feasibility study of the company’s SurgWerks system to treat late stage, no option critical limb ischemia (CLI).
The SurgWerks system is comprised of the SurgWerks Processing Platform, featuring devices and analytics, and indication-specific SurgWerks Procedure Kits designed to be used in regenerative stem cell therapy at the point-of-care for vascular and orthopedic diseases.
It is a complete sterile single-use procedure kit containing medical disposables and testing reagents which are used to collect, process and produce a therapeutic dose within the surgical scope.
The feasibility study involved 17 patients with late stage CLI treated with all the available surgical options barring a major limb amputation.
They were treated with autologous bone marrow derived from stem cells.
The follow-up was approved to determine the longer-term safety and efficacy related to limb salvage, disease progression, and quality of life improvement.
The 12 months follow-up results of the original study have demonstrated that 12 out of the 17 patients experienced successful limb salvage.
After 40 months, positive clinical outcome was noted with an overall reduction in rest pain and an improved quality of life.
Cesca Therapeutics subsidiary Totipotent study director and executive director Dr Venkatesh Ponemone said: "These longer-term, post-study follow-up results not only reinforce our belief that autologous bone marrow derived stem cell therapy using our SurgWerks-CLI system is effective, they also suggest that it is durable.”
Ponemone has added that the company is planning to initiate the Phase III pivotal clinical trial of SurgWerks-CLI procedure.