Cesca Therapeutics Inc. (NASDAQ:KOOL) has disclosed on Wednesday 40-month follow-up results of its feasibility study evaluating SurgWerks for the treatment of late-stage, no-option critical limb ischemia (CLI), which was conducted at Fortis Escorts Heart Institute, New Delhi, India in 2011.
Feasibility Study Design and Results
The feasibility study enrolled 17 subjects with late-stage CLI who have exhausted all available surgical methods short of amputations. Under the study, they were treated with autologous bone marrow derived stem cells.
The 40-month follow-up is an approved protocol that aims to evaluate longer-term safety and efficacy measures involving disease progression, limb salvage, and quality of life improvement.
The initial 12-month findings had shown that 12 out the 17 feasibility study participants experienced successful limb salvage.
For the 40-month follow-up, Cesca Therapeutics nine out of those 12 subjects were evaluated as the company failed to reach three of them.
All nine patients, who still had their limbs, have not shown any indications of disease progression. However, two of them have undergone further SurgWerks treatments during the follow-up evaluation to relieve mild-to-moderate pains. There were also no reported safety issues and adverse events during the follow-up. Overall, the 40-month follow-up results showed favorable outcomes, particularly significant pain reductions and quality of life enhancements.
Stem Cell Treatments
Dr. Venkatesh Ponemone, Cesca Therapeutics TotipotentRX Executive Director and Study Director, noted that these encouraging follow-up results underscore the long-term efficacy and durability of autologous bone marrow derived stem cell therapy with SurgWerks in helping late-stage CLI patients.
Accordingly, Cesca Therapeutics will commence the Phase III clinical trial, which has recently received the approval of the US Food and Drug Administration (FDA), anytime soon as it works on making the SurgWerks system available for all late-stage CLI patients.
The company also announced on Tuesday that the results from the Enhancement of Atrophic Nonunion Fracture Healing Using Autologous Progenitor Cell-Rich Bone Marrow study had been published in the Herald Scholarly Open Access (HSOA) Journal of Stem Cells Research, Development, and Therapy and can now be accessed online.