BioGenCell has completed the 6 Months follow-up in its first in human, phase I/II clinical trial in CLI patients (clinicaltrials.gov Identifier: NCT02805023). Results of this cohort of patients show that the treatment is safe and has therapeutic effects in both objective outcomes, including limb salvage, leg blood flow and wound healing as well as subjective outcomes including walking ability, reduction of pain and improved quality of life.
This study is being conducted at the Laniado Hospital, headed by Dr. Mark J Niven, a worldwide leader in the field of diabetes and the Director of the Endocrine and Diabetes Unit, incorporating the Bildirici Center for Diabetes Care and Research. This disease is the most serious form of peripheral vascular disease (PVD) and is the direct cause of limb amputations, as well as significant patient morbidity and mortality.
The goal beyond elimination of amputations is to extend lifespan and improve functionality and quality of life in our patients.
BioGenCell looks forward to further testing its technology in a double-blind randomized clinical