Human Acellular Vessel for Vascular Trauma

Not currently recruiting at 33 trial locations

Overseen By Mark Tulchinskiy, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Humacyte, Inc.

Must be taking: Antiplatelets

Disqualifiers: Pregnancy, Severe injuries, Amputation risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 36 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the Human Acellular Vessel (HAV) for individuals with serious blood vessel injuries in their limbs or torso, excluding the heart. Researchers aim to determine if HAV can replace or repair damaged arteries using standard surgical methods. Suitable candidates have a life-threatening arterial injury in their limb or torso requiring surgery and cannot use their own vein for the procedure. As a combined Phase 2 and Phase 3 trial, this study evaluates the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking medical advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants must be able to undergo long-term antiplatelet therapy (medication to prevent blood clots) after their injuries are treated.

What prior data suggests that the Human Acellular Vessel (HAV) is safe for vascular trauma patients?

Research has shown that the Human Acellular Vessel (HAV) has been used safely in earlier studies. In one study, 17 patients with serious injuries, including battlefield wounds, received the HAV. The results showed that the HAV was well-tolerated, with no severe side effects reported. This suggests that the HAV can be a safe option for people needing blood vessel repair after trauma. The success in these cases provides a good basis for its use in new patients facing similar surgeries. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for vascular trauma, which often involves autologous vein grafts or synthetic grafts, the Human Acellular Vessel (HAV) offers a novel approach. This treatment uses bioengineered blood vessels derived from human cells, which are then decellularized to reduce the risk of rejection and infection. Researchers are excited because HAVs can be readily available and don't rely on the patient's own veins, potentially speeding up treatment and improving outcomes in emergency situations. This method could revolutionize how life-threatening vascular injuries are treated by offering a more reliable and immediate solution.

What evidence suggests that the Human Acellular Vessel (HAV) is effective for vascular trauma?

Research has shown that the Human Acellular Vessel (HAV), which participants in this trial will receive, could effectively repair damaged blood vessels. Studies have found that HAV maintains better blood flow, with more open and unblocked vessels compared to traditional synthetic grafts. In earlier trials, HAV resulted in fewer amputations and infections. Specifically, patients who received HAV for bypass surgeries experienced significant improvements. Overall, the evidence suggests that HAV could be a reliable option for repairing blood vessel injuries. ^{1 3 4 6 7}

Who Is on the Research Team?

Shamik Parikh, MD

Principal Investigator

Humacyte, Inc.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with severe vascular injuries below the neck needing reconstructive surgery. Participants must be able to understand and follow study procedures, or have a witness who can attest to their ability if unconscious. They should not be at high risk of limb amputation, pregnant, recently in another study, employees of the sponsor or related to the investigator, nor have conditions preventing long-term antiplatelet therapy.

Inclusion Criteria

I can understand and follow the study's requirements.

The damaged blood vessel is no longer than 38cm and matches the size of the 6mm Human Acellular Vessel, as determined by the treating surgeon.

I or my relative can and agree to give informed consent.

Exclusion Criteria

Employees of the sponsor or patients who are employees or relatives of the investigator

My limb might be amputated despite attempts to save it due to severe injury.

Your injury severity score is very high.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are implanted with a Humacyte Human Acellular Vessel (HAV) as an interposition vessel or bypass using standard vascular surgical techniques

Up to 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at standard of care visits, and physical exams and ultrasounds at month 24 and month 36

36 months

What Are the Treatments Tested in This Trial?

Interventions

• Human Acellular Vessel (HAV)

Trial Overview The trial studies how well a Human Acellular Vessel (HAV) works as a replacement or bypass for damaged blood vessels in two groups: one with torso injuries and one with limb injuries. All participants will receive HAV implants using standard surgical techniques without comparison to other treatments.

How Is the Trial Designed?

Group I: Human Acellular Vessel (HAV) Experimental Treatment 1 Intervention

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 Human Acellular Vessel (HAV) as an interposition vessel or bypass using standard vascular surgical techniques.

Who Is Running the Clinical Trial?

Humacyte, Inc.

Lead Sponsor

Trials

11

Recruited

960+

Atlantic Research Group

Collaborator

Trials

9

Recruited

600+

U.S. Army Medical Research and Development Command

Collaborator

Trials

296

Recruited

249,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9976461/

Six-year outcomes of a phase II study of human-tissue ... The human acellular vessel (HAV) was evaluated for surgical bypass in a phase II study. The primary results at 24 months after implantation have been reported.

2. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2826564

Bioengineered Human Arteries for the Repair of Vascular ... This study of 2 nonrandomized clinical trials evaluates the performance of the acellular tissue engineered vessel in the repair of arterial ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03005418

NCT03005418 | Humacyte Human Acellular Vessel (HAV) ... This study evaluates the use of the Human Acellular Vessel (HAV) in adults with vascular trauma below the neck who are undergoing vascular reconstructive ...

4. mayoclinicproceedings.org mayoclinicproceedings.org/article/S0025-6196(23)00200-8/fulltext

Outcomes of Arterial Bypass With the Human Acellular ... To report outcomes of the human acellular vessel (HAV) implanted for limb salvage through the Food and Drug Administration (FDA) Expanded Access Program.

5. evtoday.com evtoday.com/news/humacyte-presents-clinical-results-of-human-acellular-vessel-for-vascular-trauma

Humacyte Presents Clinical Results of Human Acellular ... The results showed the HAV had higher rates of patency as well as lower rates of amputation and infection compared to historic synthetic graft benchmarks.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40984142/

Evaluating the Safety and Efficacy of Humacyte Acellular ... Retrospective data were collected for efficacy and safety outcomes in 17 of these patients, of whom 14 suffered battlefield injuries including ...

7. jvascsurg.org jvascsurg.org/article/S0741-5214(24)00925-X/fulltext

Current outcomes following upper and lower extremity ... We aim to evaluate the factors associated with limb salvage and mortality after extremity arterial trauma, especially with respect to the type of conduit used ...