The phase II clinical trial to be conducted by the University and BioGenCell will focus on patient responses to novel cell therapy, with the aim of saving limbs and enabling a better quality of life for those suffering.
[California, USA, April 20, 2023] – BioGenCell, the leading personalized cell therapy solution provider, announced on Thursday, April 20, that it has partnered with the University of California San Francisco (UCSF) as part of the company’s phase II clinical trials. The partnership will focus on the impact of BioGenCell’s treatment on those with chronic limb-threatening ischemia (CLTI also known as CLI), a debilitating condition commonly associated with diabetes. This is part of a worldwide multi-site placebo-controlled trial in dozens of patients across North America, Europe and Asia.
In the United States alone, around two million patients suffer from CLTI, with costs related to its treatment totaling over $4 billion annually. CLTI is a severe blockage in the arteries of the lower extremities, which significantly reduces blood-flow. This results in grave pain in the feet or toes, even while resting. Complications of CLTI can lead to amputation of the affected limb, an eventuality which the UCSF and BioGenCell trial intends to prevent entirely – life-changing for patients and their families while extracting costs from the healthcare economy.
“To develop new medicines, high-quality research must be translated into technologies through a rigorous process of assessment and carefully designed clinical trials. The unique merging of UCSF’s academic diligence with BioGenCell’s innovative approach, will be priceless to the patients in receipt of the novel treatment, as well as becoming a standard bearer for other researchers in this therapeutic discipline to follow,” says Prof. Michael Conte, Chief, Division of Vascular & Endovascular Surgery at UCSF and Principal Investigator of the study.
“Combining the world-class research at UCSF with BioGenCell’s technological knowhow and cutting-edge cell therapy platforms, promises a discovery process of real stamina, with the potential to make unrivaled headway in the pursuit to constrain CLTI and other vascular diseases,” says Dr. Yael Porat, Founder & CEO of BioGenCell. “We are positioned for a highly successful phase II trial, one which reveals strong patient impact, replicating the achievements in the earlier stages. Once properly validated and packaged, the cell therapy we offer will be a lifeline for patients afflicted with CLTI, or other painful, life-threatening vascular conditions, and will save the economy billions of dollars by avoiding countless, unnecessary surgeries and long-term treatment. This is a win for everyone, from patients to their families, to healthcare professionals to policy makers.”