NCT05873959

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Humacyte, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	HAV implantation	HAVs already implanted under humanitarian aid program to repair or reconstruct arteries following an extremity life- or limb-threatening traumatic injury.

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-05-26
• Completion: 2024-01-15
• First posted: 2023-05-24
• Last updated: 2024-11-25

Locations

3 sites across 1 country: Ukraine

Regulatory

• FDA-regulated drug study