An Observational Study to Evaluate the Safety and Efficacy of Humacyte's HAV for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma

• Sponsor: Humacyte, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05873959
• Collaborator: (none)
• Enrollment: 20
• Anticipated Duration (Months): 4

Study Details

Study Description

Brief Summary

Humacyte provided HAVs as humanitarian aid to Ukraine. This retrospective observational study is designed to collect data from patients in whom the HAVs have already been implanted on a humanitarian basis between June 2022 and May 2023.

Condition or Disease	Intervention/Treatment	Phase
Trauma; Trauma Injury; Trauma, Multiple; Trauma Blunt	Biological: HAV implantation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: An Observational Multicenter Study to Evaluate the Safety and Efficacy of Humacyte's Human Acellular Vessel in a Real World Setting for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability of the HAV [up to 12 months]

   To determine the rate of adverse events after impanation

2. Primary patency of the HAV after implantation [30 days]

   To determine the rate of HAV primary patency at 30 days after implantation

Secondary Outcome Measures

1. Frequency of Adverse Events of Special Interest (AESIs) [up to 12 months]

   To determine the rate of Adverse Events of Special Interest (AESIs), such as: thrombosis, clinically significant aneurysm or pseudoaneurysm formation, HAV spontaneous rupture, infection of the HAV conduit, and HAV abandonment.

2. HAV durability [up to 12 months]

   To determine the time frame when the HAV has not been removed, replaced, or ligated.

3. Rate of affected limb salvage/amputation after implantation [up to 12 months]

   To determine the rate of affected limb salvage/amputation after HAV implantation

4. Patency of the HAV after implantation [up to 12 months]

   To determine the rate of HAV patency (primary, primary assisted, and secondary) after implantation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with an HAV implanted to repair or reconstruct an arterial vessel following life- or limb-threatening traumatic vascular injury of an extremity.

• Aged 18 to 85 years old, inclusive.

• Patient or legal representative is able, willing, and competent to give informed consent.

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Humacyte, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Use of bioengineered human acellular vessels to treat traumatic injuries in the Ukraine-Russia conflict.

Publications

None provided.

• Responsible Party: Humacyte, Inc.
• ClinicalTrials.gov Identifier: NCT05873959
• Other Study ID Numbers: CLN-PRO-V017
• First Posted: May 24, 2023
• Last Update Posted: May 25, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Humacyte, Inc.: extremities; arterial replacement; arterial reconstruction
• Additional relevant MeSH terms: Wounds and Injuries; Multiple Trauma

Study Results

No Results Posted as of May 25, 2023