Humacyte Announces Completion of Enrollment for Studies of Bioengineered Blood Vessel
June 24, 2014
Technology represents potential for significant clinical
development in vascular tissue engineering and potential for reliable
access for ESRD patients
Multi-center studies spanning the United States and Poland
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
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.
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.