Human Acellular Vessel
– A Controlled Comparison
of Efficacy and Safety Study
ATTENTION CLINICIAN: The purpose of this website is to alert you that this patient is enrolled in the HAV-ACCESS Phase III AV Access Clinical Trial.
PRIOR TO INTERVENTION: We request that you read Intervention Guidelines and refer to the appropriate Medical Monitor phone number listed below if you have questions regarding interventions to this arteriovenous (AV) access.
This patient’s vascular access may be either an autologous arteriovenous fistula (AVF), or the Human Acellular Vessel (HAV).
Be advised, balloon for angioplasty or thrombectomy SHOULD NOT EXCEED 6MM in diameter within the HAV as disruption or tearing of HAV may occur.
ESRD patients who are currently receiving hemodialysis with a catheter (e.g. Permcath™) and who are suitable candidates for placement of a dialysis graft or creation of a dialysis fistula
Approximately 20 Sites in the United States
At least 240 patients
Approximately 12 months
EXPECTED START DATE:
FOLLOW UP PERIOD:
Up to 5 years
Medical Monitor by Region
The HAV-ACCESS Phase III clinical trial will compare the HAV with a current standard of care AVF when used for hemodialysis access in the above study population. Below you can review Intervention Guidelines, or below you can review cannulation guidelines or if you would like to learn more about the Humacyte technology, the HAV-ACCESS clinical trial, or Phase II clinical trial results.
1. We recommend needle cannulation access of the study implant in accordance with the National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines as outlined in CLINICAL PRACTICE GUIDELINES FOR VASCULAR ACCESS, Section I, Guideline 3. http://www2.kidney.org/professionals/kdoqi/guideline_uphd_pd_va/va_guide3.htm
2. For purposes of this clinical trial, the study implant will require 4 weeks of tissue incorporation time prior to cannulation and use for hemodialysis. The surgical clinician must evaluate the patient prior to use to ensure there are no contraindications for cannulation.
3. Great care must be exercised when accessing the study implant so as to not inadvertently puncture through both the anterior and posterior wall of the study implant, which may result in injury or hematoma. This is best accomplished by inserting the needle at a shallow angle (i.e., 25° or less).
4. Techniques and procedures applicable to accessing a native fistula should be practiced. We recommend the use of a 17 gauge needle for access, and a flow rate of 200-250 ml/min during the first week of use. After an initial week of successful use, the dialysis unit may step up to a 16 gauge needle and increase the flow rate to 300-350 ml/min. Assuming no issues with study implant use after the second week, the dialysis unit may increase to use of a 15 gauge needle and, at the nephrologists’ discretion, flow rates above 350 ml/min thereafter.
5. Hemostasis can be achieved with light pressure from a single digit over the puncture site on the access (which may not exactly correspond with the skin puncture site), typically in under 10 minutes.
6. It is essential to properly rotate needle sites in a “rope ladder” technique. Puncture sites must be adequately separated to allow the skin and tissue over the study implant to properly heal between needle punctures. Multiple punctures in the same area may lead to disruption of the study implant material or formation of a perigraft hematoma or pseudoaneurysm.
7. We do not recommend the use of the “button hole” technique for patients in this clinical trial.
Official Title of the Clinical Trial:
A Phase 3 Study to Compare the Efficacy and Safety of Humacyte’s Human Acellular Vessel with that of an Autologous Arteriovenous Fistula in Subjects with End‑Stage Renal Disease
Subjects with end-stage renal disease (ESRD) who are currently receiving hemodialysis with a catheter (e.g. Permcath™) and who are suitable candidates for placement of a dialysis graft or creation of a dialysis fistula will be considered for participation in this prospective, multicenter, randomized, comparative study. Subjects will be implanted with either a HAV or will have an AVF created in the forearm or upper arm using standard vascular surgical techniques. The 1:1 randomization will occur in the operating room, but prior to skin incision, and will be stratiﬁed by upper arm or forearm placement based on the Investigator’s determination of where the Study Access (SA) should be located. All subjects will be required to take daily aspirin (81-325 mg) unless they are already taking another antiplatelet agent. Subjects who are known to be aspirin-sensitive should take another antiplatelet agent at the discretion of the Investigator.
Each subject will be followed by study speciﬁc visits until the patient completes 2 years (24 months) of follow-up after implantation (irrespective of patency status). After 2 years, subjects with a HAV (irrespective of patency) and subjects with a patent AVF will be followed (while the study access remains patent) for up to 5 years (60 months) post-implantation at routine study visits. The expected duration of the clinical investigation is about 75 months (initiation of enrollment through completion of data collection).
The HUMACYTE HAV is a tissue-engineered blood vessel that is being investigated as a surgical option for vascular access. The HAV is a sterile, vascular tube, composed of human connective tissue and proteins. This complex connective tissue has similarities to human vascular tissue but HAV is non-living. To date, the HAV has been implanted in over 250 patients worldwide in various clinical trials.
To read more about the Humacyte HAV, click here.
The following clinical data were adapted from the Humacyte Phase II AV access clinical trial results as reported by Lawson, et al. The Lancet, May 2016.
Two, single arm Phase II clinical trials were conducted in adults in the US and Poland to evaluate the safety and efficacy of the novel bioengineered HAV when implanted into the arms of patients with ESRD who were deemed not suitable for fistula creation to create a vascular access for dialysis.
Primary endpoints were safety (freedom from immune response/infection, aneurysm, or mechanical failure, incidence of adverse events). Efficacy was assessed by primary, primary assisted and secondary patencies at 6 months. Secondary endpoints included patency and intervention rates at 12, 18 and 24 months, and changes in panel reactive antibodies (PRA) following HAV implantation. During the course of the trial, 60 HAVs were implanted into the arms of 60 patients at 6 centers across the US and Poland with planned 24 months of follow up. All patients in this report were followed for at least 1 year, or had a censoring event.
Conclusion: The results of the Phase II clinical trials provide evidence of the potential safety and effectiveness of the bioengineered HAV when used for hemodialysis access as well as evidence of HAV repopulation with host vascular cells, but warrant further study in randomized controlled clinical trials.
NUMBER OF PATIENTS IMPLANTED
PATENCY - NUMBER (%)
6 MONTHS36 (63%)
12 MONTHS15 (28%)
PRIMARY ASSISTED PATENCY
6 MONTHS41 (73%)
12 MONTHS20 (38%)
6 MONTHS54 (97%)
12 MONTHS 46 (89%)
INTERVENTIONS (PER PATIENT YEAR)
HAV INFECTION, NUMBER (%PPY)