Westchester Medical Center and BioGenCell Open BioGenCell's Fourth Chronic Limb-Threatening Ischemia Clinical Trial Site in the United States

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Sep 05, 2023, 12:59 ET

Westchester Medical Center (an academic affiliate of Touro University/New York Medical College) and BioGenCell have marked a milestone with the opening of a Phase II cell-therapy based clinical trial site for Chronic Limb-Threatening Ischemia (CLTI) in the United States, following Yale University New Haven Hospital, John Hopkins University, and UCSF. This initiative aims to significantly reduce the number of amputations for patients dealing with severe CLTI.

NEW YORK, Sept. 5, 2023 /PRNewswire/ -- BioGenCell, a leader in personalized cell therapy solutions and Westchester Medical Center, the academic affiliate of Touro University/New York Medical College have announced the launch of BioGenCell's fourth Phase II clinical trial site in the United States. The trial targets a considerable reduction in the need for amputation in patients with chronic limb-threatening ischemia (CLTI, also known as CLI). Westchester Medical Center, the flagship hospital in the Westchester Medical Center Health Network (WMCHealth) joins an ambitious, global, placebo-controlled trial aimed at delivering life-altering positive outcomes for patients.

The outlook for CLI patients is bleak: within a year of diagnosis, approximately 20% will not survive the disease while 30% of patients will undergo amputation. Alarmingly, nearly 70% of these amputees pass away within five years following the amputation.

BioGenCell's cutting-edge yet low-risk technology leverages the immune, stem, and progenitor cells found in the patient's own blood taken in a simple blood draw. When reinjected into the affected limb, these "trained" cells induce the formation of new, healthy blood vessels, restoring blood flow and potentially averting limb amputation or even death and significantly improving patient quality of life. BioGenCell's earlier clinical trial showed a promising long-term amputation-free survival rate.

"We are delighted to be collaborating in this trial with WMCHealth, an important hospital system in the New York metropolitan area," said Dr. Yael Porat, BioGenCell co-founder and CEO. "We hope to be able to help long-suffering individuals with CLI."

According to Igor Laskowski, MD, Westchester Medical Center's Section Chief of Vascular Surgery and the trial's principal investigator: "There is an imperative need for effective therapies. We are a center for research here at Westchester Medical Center, and we hope BioGenCell's Phase II study – and the many other studies underway at our hospital - will improve the prognosis for patients impacted by this and other incapacitating diseases."

Adds Dr. Salomon Amar, vice president for Research for Touro University and NYMC: "We are impressed with BioGenCell's results to date and are happy that our teaching hospital, Westchester Medical Center, is taking part in this important trial. It is especially gratifying for Touro to be collaborating with an Israeli company."

Those suffering from CLTI, and interested physicians, are invited to visit www.biogencelltrial.com or contact the Study Coordinator (details) for more information on participating in the clinical trial.

About BioGenCell
BioGenCell, based at Laniado Hospital in Netanya, Israel, is dedicated to improving the lives of patients suffering from degenerative microvascular diseases. BioGenCell aims to extend its reach to address a wider range of vascular and other diseases in the future. For more information, please visit https://www.biogencell.net.

About Westchester Medical Center Health Network

The Westchester Medical Center Health Network (WMCHealth) is a 1,700-bed healthcare system headquartered in Valhalla, New York, with nine hospitals on seven campuses spanning 6,200 square miles of the Hudson Valley. WMCHealth employs more than 13,000 people and has nearly 3,000 attending physicians. The Network has Level I (adult and pediatric), Level II and Level III trauma centers, the region's only acute care children's hospital, an academic medical center, several community hospitals, dozens of specialized institutes and centers, Comprehensive and Primary Stroke Centers, skilled nursing, assisted living facilities, home-care services and one of the largest mental health systems in New York State. Today, WMCHealth is the pre-eminent provider of integrated health care in the Hudson Valley. For more information about WMCHealth, visit WMCHealth.org or follow WMCHealth on Facebook.com/WMCHealth or Instagram.com/WMCHealth.

SOURCE BioGenCell