Appetite for shares of Cesca Therapeutics Inc. (NASDAQ: KOOL) surged after the company announced positive result from a follow-up to a clinical trial of its regenerative medicine. Cesca is using its proprietary SurgWerks system to develop stem-cell based treatment for a vascular disease called critical limb ischemia (CLI).
CLI is a medical problem that can lead to amputation. The risk of CLI amputation is particularly high in patients with diabetes or whose circulation is low. To give hope to these patients, Cesca Therapeutics Inc (NASDAQ:KOOL) has for years been working on its SurgWerks-based regenerative medicine.
Feasibility study in India
At some point back in 2011, Cesca decided to test its medicine at a medical facility in India, specifically in New Delhi. The company considered the Indian test as a feasibility study of CLI. Therefore, the study enrolled 17 patients who had late-stage CLI and who had exhausted surgical portions to correct their problem and were nearing amputation.
Cesca said those Indian patients were treated with autologous bone marrow that had been derived from stem cells using its SurgWerks system. The outcome was favorable. After 12 months, 12 of the 17 patients did not see their disease progress and no serious side effects were noted. As such, those 12 patients escaped amputation.
Long-term follow-up by Cesca Therapeutics Inc. (NASDAQ: KOOL)
But after many more months, 40 months to be exact, Cesca Therapeutics Inc. (NASDAQ: KOOL) decided to do a follow-up of the 12 patients to see how they were faring after receive stem cell treatment based on its technology. Though not all the 12 patients could be traced, nine of them could be assessed. KOOL found out that the nine still had their limbs and their CLI condition had not progressed.
Bringing SurgWerks to market
With the favorable long-term follow-up results, Cesca feels energized to hit the road running with a pivotal Phase 3 study of its stem cell treatment for CLI. The study has been approved by the FDA and the management of KOOL is confident that the study will be successful and pave the way to bring SurgWerks to market.
A Chinese company called Boyalife Group earlier this year injected $15 million into Cesca Therapeutics Inc (NASDAQ:KOOL) to support the clinical trials of the company’s regenerative medicine products.