Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Acellular Tissue Engineered Vessel (ATEV), Acellular Tissue Engineered Vessel, HAVG, HAV, Human Acellular Vessel (HAV), Human Acellular Vessel, Acellular Tissue Engineered Vessel (Symvess), ATEV
Symvess · 8 trials · 13 indications
Adverse Events including serious, events of special interest, and death will be assessed in the overall study population
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining ATEV patency through the 12-month follow-up period, evaluated across the entire overall study population.
Time-to-event analysis estimating the long-term cumulative probabilities of amputation-free ATEV rate through the 12-month follow-up period, evaluated across the entire overall study population.
Time-to-event analysis estimating the long-term cumulative probabilities of Infection-free ATEV rates through the 12-month follow-up period, evaluated across the entire overall study population.
To determine the number of days free from indwelling catheter (catheter-free days) since randomization to 365 days (Month 12), or until SA abandonment, whichever occurs first.
To determine the rate of infections, related to any HD access over the period from SA creation (Day 1) until 12 months (365 days) after SA placement, without regard to SA abandonment.
Co-primary endpoint #1: Proportion of subjects with functional patency at 6 months post study access (SA) creation The definition of "functional patency" is: Dialysis with "2 needles for ≥75% of dialysis sessions over a continuous 4-week period and either: (1) 4 consecutive sessions during the 4-week period in which 2 needles are used and the mean dialysis machine blood pump speed is ≥300 mL/min, or (2) a measured spKt/Vurea is ≥ 1.4 or urea reduction ratio \>70% during any session in which 2 needles are used within the 4-week period. SpKt/Vurea is calculated from pre and post-treatment serum urea nitrogen concentrations, body weight, and dialysis session duration." The functional patency ascertainment period will take place between the 1st day of Week 21 (Day 140) and the last day of Week 26 (Day 181) after AVF creation or HAV placement. The endpoint is met when the functional patency criteria are satisfied within any consecutive 4 week period within this ascertainment period.
Co-primary endpoint #2: Proportion of subjects with secondary patency of SA at 12 months post SA creation. The SA maintains secondary patency until it is abandoned, irrespective of interventions to maintain or restore patency. Abandonment is defined as AVF or HAV that can no longer be used for 2-needle, prescribed dialysis as it may be unable to provide adequate flows and/or is deemed unsafe for the subject, and the associated problem cannot be corrected by any intervention, including medical, surgical, or radiological interventions or rest.
1. Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002). 2. "Abandonment" defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned).
Frequency and severity of AEs of each patient will be documented
Assess changes in the PRA response (number of participants) over the 2 months after graft implantation
Frequency and severity of all adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI) of each patient will be documented.
Rate of primary patency at the specified milestone post-implantation, evaluated across the entire overall study population who received the Human Acellular Vessel (HAV). Primary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the evaluation milestone, without requiring any intervening surgical or endovascular interventions to maintain or re-establish flow.
Rate of primary patency at 30 days post-implantation, evaluated strictly within the sub-cohort of participants presenting with non-iatrogenic, community-acquired extremity vascular trauma. Primary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the 30-day evaluation milestone, without requiring any intervening surgical or endovascular interventions to maintain or re-establish flow.
Primary patency = patent ("open" to blood flow) without any interventions; Primary-assisted patency = patent without an intervention to clear a thrombus; Secondary patency = patent with or without interventions
The incidence of aneurysm formation, anastomotic bleeding or rupture, graft infection and irritation/inflammation/infection at the implantation site will be assessed by Doppler ultrasound and tabulated.
Determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAVG by Doppler ultrasound.
Frequency and severity of AEs of each patient will be documented.
Graft interventions of each patient will be documented.
| Arm | Type | Description |
|---|---|---|
| Symvess | EXPERIMENTAL | - |
| ATEV treatment arm | EXPERIMENTAL | ATEV will be implanted as an arterio-venous (AV) access into the forearm or upper arm |
| AVF treatment arm | ACTIVE_COMPARATOR | AVF creation procedure (1-stage AVF or 2-stage AVF) as an arterio-venous (AV) access into the forearm or upper arm |
| Human Acellular Vessel (HAV) | EXPERIMENTAL | The HAV is a tissue-engineered vascular conduit (6mm diameter) for hemodialysis access in patients with end-stage renal disease. It will be surgically implanted in the forearm or upper arm on Study Day 0. |
| Arteriovenous fistula (AVF) | ACTIVE_COMPARATOR | The comparator is an autologous arteriovenous fistula created in the forearm or upper arm on Study Day 0. |
| ePTFE | ACTIVE_COMPARATOR | One of two commercially available comparators (Bard Impra® and Gore PROPATEN®) |
| HAV | EXPERIMENTAL | The HAV is a tissue-engineered vascular conduit (6mm diameter) for hemodialysis access in patients with end-stage renal disease. HAV for this study will be manufactured using the commercial manufacturing system.It will be implanted in the forearm or upper arm using standard vascular surgical techniques. All subjects will be required to start taking daily aspirin (75 or 325 mg) on Day 1 after surgical implantation of HAV unless they are already taking another antiplatelet agent. If low molecular weight heparin (LMWH) is administered post-operatively, aspirin or other antiplatelet agents should be initiated after stopping LMWH. Subjects who are known to be aspirin-sensitive should take another antiplatelet agent at the discretion of the Principal Investigator. |
| Acellular Tissue Engineered Vessel (ATEV) | EXPERIMENTAL | Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, will be implanted with the Humacyte ATEV as an interposition vessel or bypass using standard vascular surgical techniques. |
| HAV Treatment | EXPERIMENTAL | Human Acellular Vessel (HAV) |
| HAVG | EXPERIMENTAL | Surgical placement of HAVG |
| Name | Type | Description |
|---|---|---|
| Acellular Tissue Engineered Vessel (Symvess) | BIOLOGICAL | ATEV |
| Acellular Tissue Engineered Vessel (ATEV) | BIOLOGICAL | ATEV implantation |
| AVF | OTHER | AVF creation procedure |
| Human Acellular Vessel (HAV) | BIOLOGICAL | Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access. |
| Arteriovenous fistula (AVF) | PROCEDURE | Surgical creation of an autologous arteriovenous fistula and subsequent use of the implanted vascular conduit for hemodialysis vascular access. |
| Hemodialysis | OTHER | Procedure that filters a person's blood when their kidneys are no longer functioning properly |
| ePTFE graft | DEVICE | One of two commercially available comparators (Bard Impra® and Gore PROPATEN®) |
| HAV | BIOLOGICAL | Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access. |
| HAVG | BIOLOGICAL | HAVG is implanted into patients' arm. |
Inclusion Criteria: 1. Patients 17 years of age or younger who have reached adult sexual maturity (i.e., Tanner Sexual Maturity Rating Stage 5) as determined by the Investigator a. For purposes of this study, Tanner Stage 5 is defined for both males and females as having pubic hair that extends...
Symvess is a bioengineered human acellular vessel developed by Humacyte, Inc. (ticker HUMA) as a vascular conduit. It is being studied for use in hemodialysis vascular access in end-stage renal disease and renal failure, for peripheral artery disease, and for extremity arterial injury in vascular trauma. It is an investigational product in Phase 3 development.
In end-stage renal disease, Symvess is being studied as a vascular access conduit for patients requiring hemodialysis. Clinical trials have compared it with arteriovenous fistulas in dialysis patients, including a Phase 3 study in female patients and a completed Phase 3 comparison with fistulas as hemodialysis conduits.
Symvess is developed by Humacyte, Inc., which trades under the ticker HUMA. Humacyte is the sponsor of the clinical trials evaluating the human acellular vessel across hemodialysis access, peripheral artery disease, and vascular trauma indications.
Symvess is in Phase 3 clinical development and is investigational. Its clinical program includes Phase 3 trials in hemodialysis vascular access and vascular trauma, plus a completed Phase 2 study in patients needing vascular access for dialysis. It has not been established as approved for these uses in the information available.
Symvess trials include NCT07762313, an open-label Phase 3 study of Symvess as a vascular conduit in adolescents with extremity arterial injury, and NCT05908084, a Phase 3 comparison of the ATEV with arteriovenous fistula in female end-stage renal disease patients on hemodialysis. Completed studies include NCT04135417 and NCT03183245.
Yes. Symvess is also known as the Human Acellular Vessel (HAV), the Human Acellular Vessel (HAV), and the Acellular Tissue Engineered Vessel (ATEV). These names refer to the same Humacyte product, so searches for HAV, ATEV, or Acellular Tissue Engineered Vessel lead to Symvess.