BioGenCell 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 ischaemia (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 totalling 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.
“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.
Dr Yael Porat, Founder & CEO of BioGenCell, added: “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.”
If shown to be clinically viable, this breakthrough therapy will be eligible for fast-track global commercialisation approval.