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HUMANITY Clinical Trial for AV Access

ATTENTION CLINICIAN: The purpose of this website is to alert you that this patient is enrolled in the HUMANITY™ 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.

Be advised, balloon for angioplasty or thrombectomy SHOULD NOT EXCEED 6MM in diameter within the HAV as disruption or tearing of HAV may occur.

This patient’s vascular access may be either standard expanded polytetrafluoroethylene (ePTFE), or the Human Acellular Vessel (HAV).

Humacyte HUMANITY™
Phase III Clinical Trial

STUDY POPULATION:
ESRD patients who are not or are no longer candidates for fistula placement

STUDY SITES:
Approximately 35 Sites in the US, Europe, and Israel

ENROLLMENT:
At least 350 patients

RANDOMIZATION:
1:1 ePTFE : HAV

ENROLLMENT PERIOD:
Approximately 16 months

EXPECTED START DATE:
May 2016

FOLLOW UP PERIOD:
Up to 5 years

SPONSOR:
Humacyte, Inc.

CONTACT:
Medical Monitor by Region
US: 1-800-723-2890
Israel: 1-809-315655
Poland: 00-800-112-4013
Portugal: 800-180-259
UK: 0-800-014-8926
Germany: 0800-183-8461

The Humanity Phase III clinical trial will compare the HAV with the current standard of care dialysis graft, ePTFE when used for hemodialysis access in the above study population. Below you can review Intervention or Cannulations Guidelines, or if you would like to learn more about the Humacyte technology, the HUMANITY™ clinical trial, or Phase II clinical trial results.

Content approved by WIRB 28May2016

Cannulation Guidelines

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.

Content approved by WIRB 28May2016

Clinical Trial Synopsis

An Assessment of Humacyte’s Human Acellular Vessel in Patients Needing Renal Replacement Therapy: A Comparison with ePTFE Grafts as Conduits for Hemodialysis (HUMANITY™).

Patients with end-stage renal disease (kidney failure) who require hemodialysis, but have unsuitable vessels for creation of a dialysis fistula for access will be chosen to participate in this prospective, multicenter, multinational, randomized, comparative study. Patients will be implanted in the forearm or upper arm with either a Humacyte Vessel (HAV) or a dialysis graft, the standard of care. The 1:1 randomization (a 50/50 chance of receiving the HAV or standard graft) will occur during surgery once your surgeon has determined where the study conduit should be placed. All patients will be required to take daily aspirin (75 to 325 mg) unless they are already taking another antiplatelet agent (e.g., Plavix).

Each patient will be followed by study specific visits through 2 years (24 months) of follow up after implantation (whether the vessel or graft is open and functioning or not). After 2 years, only subjects with an open and functioning access will be followed (while the access remains open) for up to 5 years (60 months) post-implantation at routine study visits.

SCHEDULE OF STUDY SPECIFIC VISITS

  • Screening Visit (up to 35 days
    prior to surgery date)
  • Day 0 (Surgery day)
  • Post op Day 7-15
  • 1 month
  • 2 months
  • 3 months
  • 6 months
  • 9 months
  • 1 year
  • 18 months
  • 2 years
  • Visits will continue every
    6 months from month 30 – 60
    as long as the access remains
    open and functional
All visits include:
  • A general physical exam
  • Evaluation of the study access
  • Documentation of:
    • Problems
    • Work done to the study access
    • Perm cath placement
    • Medications
Some visits will include:
  • Ultrasound imaging of the study
    access
  • Lab work

Humacyte Vessel

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 read more about the Humacyte HAV, click here.

Phase II Clinical Trial Results

The following clinical data were adapted from the Humacyte Phase II 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.

US / POLAND
COMBINED

NUMBER OF PATIENTS IMPLANTED

60

PATENCY - NUMBER (%)

PRIMARY PATENCY

6 MONTHS36 (63%)

12 MONTHS15 (28%)

PRIMARY ASSISTED PATENCY

6 MONTHS41 (73%)

12 MONTHS20 (38%)

SECONDARY PATENCY

6 MONTHS54 (97%)

12 MONTHS 46 (89%)

INTERVENTIONS (PER PATIENT YEAR)

1.89

HAV INFECTION, NUMBER (%PPY)

1(1.3%)