Humacyte
Clinical Trials
Humacyte
Clinical Trials
Advancing Medicine, Together
At Humacyte, our commitment to transforming patient care by developing innovative, first-in-class regenerative medicine technologies is at the heart of everything we do. Clinical trials are the cornerstone of our progress, bridging groundbreaking science with real-world impact.
We are deeply grateful for your interest in our trials. By joining us, you become a vital part of the discovery process, helping us turn bold ideas into new therapies for those suffering from injury and disease.
Thank you for considering being part of our mission.
CLINICAL STUDY
A Phase 3 Prospective, Randomized Study to Compare the Efficacy and Safety of the Acelluar Tissue Engineered Vessel (ATEV™) With That of an Autogenous Arteriovenous Fistula (AVF) in Female Patients With End-Stage Renal Disease Requiring Hemodialysis
Status
RECRUITING
Study ID
CLN-PRO-V012
CLINICALTRIALS.GOV ID
NCT05908084
Overview
The goal of this clinical trial is to compare the number of catheter-free days (CFD) and the rate and severity of any dialysis access-related infections between the ATEV and AVF groups over 12 months in female patients with end-stage renal disease (ESRD) needing hemodialysis (HD).
Participation Requirements
Ages Eligible for Study
18 Years and older
Gender Eligible for Study
Female
Accepts Healthy Volunteers
No
Study Details
Medical Condition
End Stage Renal Disease (ESRD), Requiring Hemodialysis
Study Design
Prospective, multicenter, randomized, two-arm
Date
First Submitted April 28, 2023
Study Phase
Phase 3
Study Type
Interventional
Treatment Arms
Patients are receiving ATEV (Formally Known as HAV) or AVF
Eligibility Criteria
INCLUSION CRITERIA
- Female patients with ESRD, currently receiving hemodialysis via dialysis catheter and who are candidates for the creation of an AVF (see Inclusion Criterion #4 below) or implantation of an ATEV for HD access.
- Patients who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least 12 months after Study Access (SA) creation.
- Patients aged ≥ 18 years at Screening.
-
Suitable anatomy for creation of a forearm or upper arm AVF and for implantation of straight, curved, or looped ATEV in either the forearm or upper arm.
NOTE: Suitable anatomy will be determined by both physical examination and ultrasound imaging or vessel imaging modality in addition to consideration of all vascular sites available, prior access failure, future access sites and possibilities to preserve patients’ future alternate accesses. Vessel mapping is the preferred method to assess the vascular anatomy, and will evaluate the following attributes during Screening:
- Vein diameter
- Arterial diameter
- Presence of arterial calcification
- Depth of the intended fistula conduit from the surface of the skin
- Central vein patency
- Previous vascular access location
- The ultimate decision of anatomic suitability belongs to the surgeon and/or the investigator
- Hemoglobin ≥ 7 g/dL and platelet count ≥ 100,000 /mm3.
- Patients must either:
- Be of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile (i.e., total hysterectomy or tubal ligation, or complete bilateral oophorectomy) at least 1 month prior to Screening.
- Or, if of childbearing potential:
- Must have a negative serum pregnancy test at Screening, and
- Must agree to use at least one form of the following birth control methods for the duration of the study:
- Established use of oral, injectable or implanted hormonal methods of contraception.
- Placement of an intrauterine device or intrauterine system at least 5 days prior to Screening.
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- Patient or their legal representative can communicate effectively with investigative staff, is competent and willing to give written informed consent, and able to comply with entire study procedures including all scheduled follow-up visits.
- Life expectancy of at least 1 year confirmed by Charlson Comorbidity Index ≤ 9.
EXCLUSION CRITERIA
- Male sex at birth.
- Planned AVF creation by means other than suture or vascular anastomotic clips (e.g., endovascular surgery or other anastomotic creation devices). Venous outflow from study access cannot be located more distally than the venous outflow of any previous failed access in that extremity.
- Known serious allergy or intolerance to aspirin and alternative antiplatelet therapy.
- Pregnancy, or women intending to become pregnant during the course of the trial.
- Treatment with any investigational drug or device within 60 days or 5 half-lives after taking the last dose (whichever is longer) prior to study entry (Day 1) or ongoing participation in a clinical trial of an investigational product.
- Documented hyper-coagulable state, as defined as either:
- Documented hyper-coagulable state, as defined as either: A biochemical diagnosis (e.g., Factor V Leiden, Protein C deficiency, etc.) - OR -
- A clinical history of thrombophilia as diagnosed by 2 or more spontaneous intravascular thrombotic events (e.g., deep vein thrombosis (DVT), pulmonary embolism (PE), etc.) within the previous 5 years.
- Spontaneous or unexplained bleeding diathesis clinically documented within the last 5 years or a biochemical diagnosis (e.g., von Willebrand’s disease, etc.).
- Cancer actively being treated with a cytotoxic agent.
- Planned or anticipated renal transplant within 6 months after randomization.
- Any other condition that in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SA.
- Previous exposure to ATEV.
- Any of the following within 8 weeks prior to screening: acute coronary syndrome, stroke or congestive heart failure NYHA Stage IV.
- Employees of Humacyte and employees or relatives of an investigator.
This Study Has 32 Locations
Arizona Locations
Scottsdale, Arizona, United States, 85260
Recruiting
Honor Health Scottsdale Shea Medical Center
California Locations
El Centro, California, United States, 92243
Recruiting
El Centro Regional Medical Center
La Jolla, California, United States, 92037
Recruiting
Jacob's Medical Center at UC San Diego Health
Colorado Locations
Denver, Colorado, United States, 80204
Recruiting
Denver Health and Hospital Authority
Connecticut Locations
New Haven, Connecticut, United States, 06519
Recruiting
Yale New Haven Hospital
Florida Locations
Brooksville, Florida, United States, 34613
Recruiting
Access Research Institute
Gainesville, Florida, United States, 32608
Recruiting
University of FL Health Heart and Vascular Hospital
Jacksonville, Florida, United States, 32224
Recruiting
Mayo Clinic Florida
Miami, Florida, United States, 33156
Recruiting
American Access Care of Miami, LLC
Tampa, Florida, United States, 33606
Recruiting
USF Health South Tampa
Georgia Locations
Atlanta, Georgia, United States, 30046
Recruiting
Georgia Nephrology
Atlanta, Georgia, United States, 30303
Recruiting
Grady Memorial Hospital
Indiana Locations
Bloomington, Indiana, United States, 47408
Recruiting
IU Health Bloomington Hospital
Maryland Locations
Baltimore, Maryland, United States, 21287
Recruiting
John Hopkins University School of Medicine
Massachusetts Locations
Boston, Massachusetts, United States, 02115
Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02118
Recruiting
Boston Medical Center
Michigan Locations
Ann Arbor, Michigan, United States, 48109
Recruiting
University of Michigan
New Jersey Locations
Newark, New Jersey, United States, 07103
Recruiting
Rutgers University_Medical
Paterson, New Jersey, United States, 07503
Recruiting
St.Joseph's University Medical Center
Pennington, New Jersey, United States, 08534
Recruiting
Capital Health Medical Center- Hopewell
New York Locations
Flushing, New York, United States, 11355
Recruiting
New York-Presbyterian Queens_The Lang Center for Research & Education
Valhalla, New York, United States, 10595
Recruiting
Ambulatory Care Pavilion Westchester Medical Center
North Carolina Locations
Charlotte, North Carolina, United States, 28207
Recruiting
Surgical Specialists of Charlotte
Durham, North Carolina, United States, 27704
Recruiting
Duke Regional Hospital
Winston-Salem, North Carolina, United States, 27157
Recruiting
Wake Forest University School of Medicine_Atrium Health Wake Forest Baptist
Pennsylvania Locations
Philadelphia, Pennsylvania, United States, 19140
Recruiting
Temple University
Tennessee Locations
Knoxville, Tennessee, United States, 37920
Recruiting
University of Tennessee Medical Center
Texas Locations
Austin, Texas, United States, 78701
Recruiting
Dell Seton Medical Center at The University of Texas at Austin
Lubbock, Texas, United States, 79407
Recruiting
Dr. Ruben Villa__Nephrology
Lubbock, Texas, United States, 79410
Recruiting
Cataract & Surgery Center Lubbock
San Antonio, Texas, United States, 78221
Recruiting
San Antonio Vascular and Endovascular Clinic PLLC
San Antonio, Texas, United States, 78221
Recruiting
The San Antonio Vascular and Endovascular Clinic