A Pilot Study for Evaluation of the Safety and Efficacy of Humacyte's Human Acellular Vascular Graft for Use as a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- HAVG safety & tolerability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with end stage renal disease (ESRD) who are not, or who are no longer, candidates for creation of an autogenous AV fistula and therefore need placement of an AV graft in the upper extremity to start or maintain hemodialysis therapy
- •Patients between 18 and 75 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 ≥8g/dL and platelet count ≥100,000/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 INR ≤ 1.5 prior to Day
- •Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures
- •Able and willing to give informed consent
- •Life expectancy of at least 1 year
排除标准
- •History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months of study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
- •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 six (6) months of study entry (Day 1)
- •Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
- •Treatment with vitamin K-antagonists or direct thrombin inhibitors within the previous month to study entry (Day 1)
- •All patients (including both female patients of childbearing potential and male patients with childbearing potential partners) who do not use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly), e.g. implants, injectables, combined oral contraceptives in combination with a barrier method, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner
- •Active diagnosis of cancer within the previous year
- •Immunodeficiency including AIDS / HIV
- •Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events
- •Bleeding diathesis
- •Active autoimmune disease
- •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/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
- •Patients receiving a lower extremity AV access
- •Known serious allergy to aspirin or penicillin
- •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
- •PRA > 20% (first 10 patients only)
结局指标
主要结局
HAVG safety & tolerability
时间窗: At each visit within first 6 months after HAVG implantation.
The incidence of aneurysm formation, anastomotic bleeding or rupture, graft infection and irritation/inflammation/infection at the implantation site will be tabulated by visit and overall.
HAVG patency rate
时间窗: At 6 months after HAVG implantation.
Determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAVG.
次要结局
- Patency maintenance/restoration(At each visit except screening.)
- PRA response(At screening, day 15, 29, 57 and week 12, 26)
- IgG antibodies(At screening, day 15, 29, 57 and week 12, 26)
- HAVG patency rates(At 12, 18, 24 months after HAVG implantation.)