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

NCT05873959 | Completed FDA Drug

• 1 other identifier: CLN-PRO-V017
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 3

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.

Conditions

Trauma; Trauma Injury; Trauma, Multiple; Trauma Blunt

Keywords

extremities; arterial replacement; arterial reconstruction

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of the HAV

  To determine the rate of adverse events after impanation

  up to 12 months

• Primary patency of the HAV after implantation

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

  30 days

Secondary Outcomes (4)

• Frequency of Adverse Events of Special Interest (AESIs)

  up to 12 months

• HAV durability

  up to 12 months

• Rate of affected limb salvage/amputation after implantation

  up to 12 months

• Patency of the HAV after implantation

  up to 12 months

Interventions

HAV implantation BIOLOGICAL

HAVs already implanted under humanitarian aid program to repair or reconstruct arteries following an extremity life- or limb-threatening traumatic injury.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with vascular trauma in the extremities who required arterial replacement or reconstruction and in whom the HAVs have been already implanted on a humanitarian basis between June 2022 and May 2023.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Humacyte, Inc.: lead

Study Sites (3)

Municipal Non-Profit Enterprise ""City Clinical Hospital #16" of the Dnipro City Council"

Dnipro, Ukraine

Location

Medical Center LLC "CLINIC VERUM EXPERT"

Kyiv, Ukraine

Location

Communal non-profit enterprise "Vinnytsia Regional Clinical Hospital named after E. Pirogov" of the Vinnytsia Regional Council, center of cardiovascular surgery

Vinnytsia, Ukraine

Location

Related Publications (2)

• Sokolov O, Shaprynskyi V, Skupyy O, Stanko O, Yurets S, Yurkova Y, Niklason LE. Use of bioengineered human acellular vessels to treat traumatic injuries in the Ukraine-Russia conflict. Lancet Reg Health Eur. 2023 May 6;29:100650. doi: 10.1016/j.lanepe.2023.100650. eCollection 2023 Jun. No abstract available.

  PMID: 37213923 BACKGROUND

• Moore EE, Curi M, Namias N, Kundi R, Lum YW, Fox CJ, Rajani RR, Rasmussen TE, Sokolov O, Niklason LE, Khondker Z, Parikh SJ; CLN-PRO-V005 Investigators and the CLN-PRO-V017 Investigators. Bioengineered Human Arteries for the Repair of Vascular Injuries. JAMA Surg. 2025 Feb 1;160(2):181-189. doi: 10.1001/jamasurg.2024.4893.

  PMID: 39565635 RESULT

Related Links

• Lancet Regional Health Europe

MeSH Terms

Conditions

Wounds and Injuries; Accidental Injuries; Multiple Trauma; Wounds, Nonpenetrating

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 24, 2023
• Study Start: May 1, 2023
• Primary Completion: May 26, 2023
• Study Completion: January 15, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

UA (3)