RESEARCH TRIANGLE PARK, N.C. -- (BUSINESS WIRE) -- Humacyte, Inc., a pioneer in regenerative medicine, has announced the completion of patient enrollment for two multi-center, investigative studies to assess the safety and efficacy of HumaGraft™, a bioengineered blood vessel.
Arteriovenous Replacement in Europe
To date, 40 patients have enrolled in an investigative, arteriovenous (AV) replacement study in Europe, which is taking place in a total of 3 centers in Poland. The trial is being conducted at medical centers in Clinic of Vascular Surgery and Angiology, Medical University in Lublin; Regional Specialist Hospital and the Clinic of Vascular Surgery, Wroclaw; and Independent Public Central Clinical Hospital, Department of General, Vascular and Transplant Surgery, Warsaw.
Arteriovenous Replacement in the U.S.
In addition, 20 patients have been enrolled in an additional investigative arteriovenous (AV) replacement study in the United States, which is taking place in a total of 3 centers. Study sites include Duke University Medical Center Department of Vascular Surgery, Durham, NC; The Methodist Hospital in Houston, Texas; and Sentara Norfolk General Hospital Vascular Specialists in Norfolk, VA.
About the Studies
Eligible patients for both studies include those who have End Stage Renal Disease (ESRD), are not candidates for an arteriovenous (AV) fistula, and need placement of an arteriovenous graft to provide access for hemodialysis therapy.
HumaGraft™ is intended as an alternative to synthetic AV grafts for the creation of vascular access for dialysis for patients with ESRD. The initial results of these investigative trials are promising. Depending on the ultimate success of the trials, they could lead to new treatments in ESRD.
Potential to Provide Reliable Access for HD Patients
Current standard of care for AV graft access includes synthetic polytetrafluoroethylene (PTFE) grafts, which are subject to a range of complications including clotting, high rates of stenosis (an abnormal narrowing in a blood vessel that can lead to occlusion), and high intervention rates to maintain blood flow. Approximately half of the PTFE grafts that are placed for hemodialysis fail within a year, requiring replacement surgery. Preliminary clinical findings suggest HumaGraftTM may be a better alternative to PTFE and may represent a significant clinical development in vascular tissue engineering. HumaGraftTM is a bioengineered blood vessel that is designed to be available off-the-shelf, with the potential to help reduce or avoid surgical interventions and hospitalizations for patients with ESRD.
Last year at the American Heart Association (AHA) Scientific Sessions, clinical researchers presented data that suggested that HumaGraftTM may be associated with improved rates of functional patency and availability for dialysis, as compared to other alternatives for dialysis access. Low rates of graft failure are also consistent with the preclinical data from animal testing of HumaGraftTM demonstrated little intimal hyperplasia, which is a common cause of failure for current dialysis access products. Preclinical data also indicated that in animals, HumaGraftTM was remodeled to become living tissue in the recipient.
For more information visit: http://www.humacyte.com.
Humacyte, Inc., a privately held company founded in 2004, is a medical research, discovery and development company with clinical and pre-clinical stage investigational products. Humacyte is primarily focused on developing and commercializing a proprietary novel technology based on human tissue-based products for key applications in regenerative medicine and vascular surgery. The company uses its innovative, proprietary platform technology to engineer human, extracellular matrix-based tissues that can be shaped into tubes, sheets, or particulate conformations, with properties similar to native tissues. These are being developed for potential use in many specific applications, with the goal to significantly improve treatment outcomes for many patients, including those with vascular disease and those requiring hemodialysis. The company’s proprietary technologies are designed to create off-the-shelf products that, once approved, can be utilized in any patient. The company web site is www.humacyte.com.