Cesca Therapeutics Shares Long-Term Data from Critical Limb Ischemia Study

Longer-term follow up information from Cesca Therapeutics’ feasibility study of Surgwerks CLI is now available. Surgwerks CLI is a candidate therapeutic device kit for treating Rutherford category 5 and Fontaine IV (end-stage) critical limb ischemia (CLI).

The Safety and Efficacy of Autologous Bone Marrow Mononuclear Cells in Patients with Severe Critical Limb Ischemia was a single center, unblinded, single arm study in 17 patients with late-stage CLI. The original study results were announced in January. This extended six month follow-up period beyond the study closure at 12 months was approved as a protocol amendment by the central Institutional Ethics Committee of Fortis Escorts Heart Institute based in New Delhi, India specifically to measure certain safety endpoints. One such safety endpoint is to ensure that vasculogenesis occurs in the targeted treatment limb but not in other areas of the body. The standard for assessing undesired neovasculogenesis is the assessment of the fundus (eye retinal bed) for changes in vascularity over time. The other safety endpoints evaluated were specific to serious adverse events including new amputation procedures or rehospitalization.

Fifteen of the 17 intent-to-treat subjects were clinically examined for changes to the fundus and also for limb ulcer/gangrene evaluation six months after the study conclusion. The results showed no proliferative changes to the retinal vascularization, a strong indication that the therapy impacts only the treated tissue. Each patient reported no new adverse or serious adverse events since the close of the study, and 14 of 17 subjects had their treated limbs intact (same number as reported at the study conclusion) without any additional minor or major amputations occurring since the trial conclusion. The study now has a median follow-up of 26.1 months.

This data will be presented by the company in a scientific and clinical presentation on June 14 at the Stem Cell and Regenerative Medicine Annual Congress in Shijiazhuang, China.

“I look forward to presenting our new data at the Vascular Surgery panel meeting this Saturday in China,” said Kenneth Harris, President of Cesca Therapeutics. “These results demonstrate our SurgWerks-CLI therapeutic kit shows promise in safely slowing the progression of disease by rescuing the limbs at such a critical point in the end stages of peripheral vascular disease.”

“We are highly encouraged by this new data,” said CEO Matthew Plavan. “Confirming no new serious adverse patient events resulting from our treatment and a high percent of intact limbs at a 26 month median follow-up measurement, we think demonstrates promising evidence of safety and treatment durability of our autologous-based SurgWerks candidate therapy.”

Cesca Therapeutics Inc. is an autologous cell-based regenerative medicine company based in Ranchi Cordova, Calif.