Cesca's SurgWerks platform recently received three U.S. patents.

Nanjing Huaxun News: Cesca is the world's largest stem cell automation equipment supplier. It is reported that the world's major well-known stem cell banks, including CBR, the largest stem cell bank in the United States, New York Blood Bank, Hong Kong Red Cross, Cryolife, Texas, Bangkok, Thailand, as well as China's Beijing Cord Blood Bank, Guangdong Cord Blood Bank, Beike Biology, etc., all use Boya's patented AXP stem cell automatic separation equipment and technology.

Cesca's SurgWerksTM platform recently received three U.S. patents.

Cesca Company announced on October 18, 2016 that the United States Patent & Trademark Office (USPTO) granted Cesca a series of patents (No. 9393269, No. 9402867, No. 9439930) on the SurgWerks platform developed by Cesca, involving the treatment of ischemic vascular diseases, such as severe lower limb ischemia (critical limb ischemia,CLI) and acute myocardial infarction (AMI). SurgWerks is a rapid immediate infusion technology platform for autologous stem cell regeneration therapy, including the collection, preparation, infusion and detection of autologous cells.

"These patents cover a critical approach for rapid infusion of autologous bone marrow-derived stem/progenitor cells, based on our proprietary SurgWerks platform processing technology," said Dalip Sethi, Ph.D., director of clinical research at Cesca. "Our SurgWerks platform patents underpin our rapid and point-of-care approach for the treatment of cardiovascular disease".

Cesca has more than 30 leading patents covering the enrichment and storage of cord blood-derived stem/progenitor cells. With expanded intellectual property rights covering key components of the SurgWerks platform, the company seeks to achieve the same innovation in the field of autologous bone marrow-derived stem cells for immediate treatment of cardiovascular and orthopedic diseases.

Clinical Research Progress of Cesca in Ischemic Diseases

Cesca has completed the "Safety and Efficacy Study of Autologous Bone Marrow Mononuclear Cells for the Treatment of Critical Lower Limb Ischemia (Critical Limb Ischemia Rapid Stem Cell Therapy,CLIRST)," Clinicaltrials Registration Number NCT01472289. In this study, 17 patients with severe limb ischemia requiring amputation were treated with autologous bone marrow mononuclear cells. After 12 months of follow-up, 14 patients avoided amputation, that is, the survival rate of non-amputation of the main limb was 82.4 (14/17); Resting pain was reduced; 6-minute walking distance was significantly improved; Open wound healing (ulcer and gangrene) and angiogenic collateral circulation were established.

At present, Cesca's phase III clinical study (CLIRST III, registration number NCT02538978) using autologous stem cell technology (SurgWerks system and VXP rapid infusion system) to treat advanced CLI has been approved by FDA. The study will start in January 2017 and is expected to include 224 patients with advanced CLI (grade 5). It will be jointly conducted in more than 40 medical centers in the United States. The SurgWerks platform is used to treat patients with advanced CLI.

In addition, Cesca has also achieved remarkable results in clinical trials for the treatment of acute myocardial infarction (AMI) (AMIRST, NCT01536106). The article was published in the Journal of the International Cardiovascular Society in June 2016 [1]. A 43-year-old patient with AMI was treated with Cesca's rapid (60-90 minute) autologous bone marrow cell therapy system: stem cell collection, preparation, testing, and treatment components. After 2 years of follow-up, the patient's ejection fraction (LVEF) improved from 35 percent at baseline to 60.3 percent, and cardiac function improved significantly.