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 today 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.”
BioGenCell is a global innovator in cell therapy and its first-of-its-kind technology enables the rapid creation of easy-to-use, cost-effective treatments for a wide range of degenerative diseases. UCSF is a world-renowned research center with a state of the art vascular department, and the partnership will broaden the intelligence and insight into the manifestation of, and subsequent treatment for CLTI. If shown clinically viable, this breakthrough therapy will be eligible for fast-track global commercialization approval, allowing BioGenCell to provide its pioneering technology for regenerative medicine to many microvascular diseases.
BioGenCell is dedicated to improving the lives of patients suffering from degenerative microvascular diseases. BioGenCell’s revolutionary and patented TRACT platform (Tissue Regenerative Activated Cell Therapy) offers a simple, easily standardized and highly accessible 3-step solution consisting of blood collection; a rapid procedure in which a patient’s own cells are turned into a personalized medicine; and a one-time injection. TRACT’s single treatment can be delivered within a day. The Company’s active phase II trial, set to take place across the US, EU and Asia, with the participation of top-tier institutions (Yale University’s New Haven Hospital is the first active site in the US). It is focused on BGC101, aimed at saving CLI patients from amputation.
In addition to the “life with a quality of life” this treatment is intended to provide to CLI patients, it has the potential to save billions of dollars each year that are used to cover costly surgical procedures.
BGC101 is part of the BGC10X product line, focused on degenerative microvascular diseases. The Company’s goal is to utilize TRACT to treat a broader array of vascular and other diseases in the future – such as heart diseases, strokes and cancer – providing accessible and personalized solutions. Co-founded by Yael Porat and Eyal Peleg and based in Netanya, Israel, BioGenCell is at the forefront of cellular medicine. For more information, please visit https://www.biogencell.net.