Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease

Humacyte

Status and phase

Completed

Phase 1

Conditions

End-stage Renal Disease

Kidney Failure, Chronic

Treatments

Biological: HAVG

Study type

Interventional

Funder types

Industry

Identifiers

NCT01840956

CLN-PRO-V003

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG.

The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the creation of vascular access for dialysis.

Full description

The HAVG is a sterile, non-pyrogenic, acellular tubular graft composed of human collagens and other natural extra-cellular matrix proteins. Upon implantation, it is anticipated (based on pre-clinical studies) that the collagen-based matrix comprising the graft will be infiltrated with host cells and re-modeled by the host. This will result in a vascular structure more similar to the histological composition of the native vascular tissue that may improve graft longevity and be less likely to become infected.

Enrollment

20 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with ESRD who are not, or who are no longer candidates for creation of an autologous AV fistula and therefore need placement of an AV graft in the upper extremity to start or maintain hemodialysis therapy
Age 18 to 80 years old, inclusive
Suitable anatomy for implantation of straight forearm grafts or curved upper arm grafts (arterial anastomosis to radial or brachial artery, venous anastomosis to either brachial cephalic or very central basilica vein)
Hemoglobin ≥8 g/dL and platelet count ≥100,000 cells/mm3 prior to Day 1
Other hematological and biochemical parameters within a range consistent with ESRD and acceptable for the administration of general anesthesia prior to Day 1
Adequate liver function, defined as serum bilirubin ≤1.5 mg/dL; GGT, AST, ALT, and alkaline phosphatase ≤2x upper limit of normal or international normalized ratio (INR) ≤1.5 prior to Day 1.
Able to communicate meaningfully with investigative staff, competent to give written informed consent, and able to comply with entire study procedures
Able and willing to give informed consent
Life expectancy of at least 1 year

Exclusion criteria

History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within 6 months of study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
Uncontrolled or poorly controlled diabetes; hospitalization for poor glucose control within the previous 6 months is an absolute exclusion criterion
History or evidence of severe peripheral vascular disease in the upper limbs
Known or suspected central vein obstruction on the side of planned graft implantation
Stroke within 6 months of study entry (Day 1)
Candidate for renal transplantation
Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
Treatment with vitamin K-antagonists, factor Xa inhibitors, or direct thrombin inhibitors within the month prior to study entry (Day 1)
Female patients who are pregnant, intending to become pregnant, nursing or intending to nurse during the study
Female patients of child bearing potential (not surgically sterile or at least 2 years post menopause) who do not use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly), eg, implants, injectables, combined oral contraceptives in combination with a barrier method, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner
History of cancer with active disease or treatment within the previous year
Immunodeficiency including AIDS / HIV
Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events (thromboses of previous dialysis accesses do not count)
Bleeding diathesis
Active clinically significant autoimmune disease
History of heparin-induced thrombocytopenia
Previous PTFE graft in the operative limb unless the HAVG can be placed more proximally than the previous failed graft
More than 1 failed PTFE graft in the operative limb
Active local or systemic infection (WBC > 15,000 cells/mm3)
Patients receiving a forearm graft with which crosses the elbow
Patients receiving an upper arm graft with arterial anastomosis to the axillary artery or venous anastomosis to the axillary vein unless low in the axilla and accessible for ultrasound monitoring and compression
Patients receiving a lower extremity AV access
Known serious allergy to aspirin
Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the HAVG
Previous enrollment in this study
Employees of the sponsor or patients who are employees or relatives of the investigator