Humacyte Acellular Tissue Engineered Vessel (ATEV) in Patients With Vascular Trauma

A Phase 2/3 Study for the Evaluation of Safety and Efficacy of Humacyte's ATEV for Vascular Replacement or Reconstruction in Patients With Life or Limb-threatening Vascular Trauma

This study evaluates the use of the Acellular Tissue Engineered Vessel (ATEV) in adults with vascular trauma below the neck who are undergoing vascular reconstructive surgery. There will be an extremity cohort and an torso cohort. All subjects will be implanted with an ATEV as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.

Study Overview

• Status: Completed
• Conditions: Trauma; Vascular System Injury
• Intervention / Treatment: Biological: Acellular Tissue Engineered Vessel (ATEV)

Detailed Description

This is a prospective, multicenter, multi cohort, non-randomized phase 2/3 study in adult patients with life or limb threatening vascular trauma which requires surgical repair.

There will be an extremity cohort and a torso cohort. The extremity cohort will include patients who require repair of a vessel contained to the upper or lower extremity. The torso cohort includes patients who require repair of vessels within the thorax (excluding the heart), abdomen, and retroperitoneum. Subjects will be implanted with an ATEV as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.

The active study duration for each study participant will be 36 months from implantation or until ATEV failure/ removal/ death, if earlier. Follow up after month 12 will involve the capture of information on assessments performed at "standard of care" routine clinic visits or by telephone follow up with the patient or his/her physician with physical exam and ultrasound at month 24 and month 36.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Israel
  • Beersheba, Israel, 8410101
    • Soroka Medical Center - Vascular Surgery Department
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
• United States
  • California
    • La Jolla, California, United States, 92037
      • Jacob Medical Center at UC San Diego
    • Los Angeles, California, United States, 90033
      • Keck Hospital of University of Southern California (USC)
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Cener
    • Orange, California, United States, 92868
      • UCI Medical Center
    • Sacramento, California, United States, 95817
      • University California, Davis
    • San Diego, California, United States, 92103
      • University of California San Diego (UCSD) Medical Center
  • Colorado
    • Denver, Colorado, United States, 80204
      • Ernest E Moore Shock Trauma Center at Denver Health
  • Florida
    • Jacksonville, Florida, United States, 32209
      • UF Health Jacksonville
    • Miami, Florida, United States, 33136
      • Ryder Trauma Center
    • Miami, Florida, United States, 33136
      • Jackson South Medical Center
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center
    • Baltimore, Maryland, United States, 21201
      • R Adams Cowley Baltimore Shock Trauma
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Saint Louis University (SLU)
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
    • Newark, New Jersey, United States, 07103
      • Rutgers New Jersey Medical School
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Hospital
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest School of Medicine
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78701
      • The University of Texas - Dell Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, which requires replacement or reconstruction
• Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6 mm Acellular Tissue Engineered Vessel (ATEV) per the judgment of the treating surgeon taking into account vasoconstriction and situational inflow and outflow considerations.

• Autologous vein graft is either not feasible in the judgment of the treating surgeon (e.g. because of lack of availability of suitable conduit, presence of severe venous insufficiency) or is not desirable because of the urgency of revascularization

  • Able to communicate meaningfully with investigative staff, and able to comply with entire study procedures. If the patient is unconscious, then information from a reliable witness indicates that the patient would normally be able to comply with study procedures
  • Patient or relative is able, willing and competent to give informed consent
• Life expectancy of at least 1 year

Exclusion Criteria:

• Mangled Extremity Severity Score (MESS) of ≥ 7
• Limb at high risk of amputation despite vascular reconstruction (e.g., because of crush injury)
• Catastrophic injuries that make survival unlikely (e.g. Abbreviated Injury Scale (AIS) > 5 or Injury Severity Score (ISS) >60)
• ATEV may not be used for coronary artery repair
• Known pregnant women
• Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries
• Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the ATEV
• Previous exposure to ATEV
• Known participation in any investigational study within the last 30 days
• Employees of the sponsor or patients who are employees or relatives of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Acellular Tissue Engineered Vessel (ATEV); 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.

Biological: Acellular Tissue Engineered Vessel (ATEV); The investigational medicinal product (IMP) - the Acellular Tissue Engineered Vessel (ATEV) is a sterile acellular tubular graft composed of human collagen types I and III and other extracellular matrix proteins, including fibronectin and vitronectin which can be used for arterial bypass or reconstruction in patients with life or limb threatening vascular trauma. The vessel is 6 mm in diameter and approximately 42 cm in length. The product is supplied on a silicone mandrel immersed in sterile phosphate buffered saline in a sealed and labeled plastic container. The ATEV is implanted using standard vascular surgical techniques similar to placement of predicate peripheral vascular prostheses.; Other Names: Human Acellular Vessel (HAV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group	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.	30 days from time of implantation
Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the Extremity Community-Acquired Trauma Subgroup	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.	30 days from time implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group	Rate of secondary patency at the specified milestone post-implantation, evaluated across the entire overall study population who received the Human Acellular Vessel (HAV). Secondary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the evaluation milestone, including vessels that became occluded but were successfully restored to patency via intervening endovascular or surgical re-intervention (e.g., thrombectomy, thrombolysis, or patch angioplasty).	30 days from time of implantation
HAV Infection Free Rate at Day 30 in the All HAV Group	The percentage of participants who remained entirely free from a confirmed, adjudicated infection of the implanted Human Acellular Vessel (HAV) conduit through the specified follow-up milestone, evaluated across the entire overall study population. An infection event is defined by clinical signs coupled with microbiologic confirmation from wound/perigraft cultures, or an independent clinical adjudication confirming a graft-specific infectious complication requiring targeted antibiotic therapy, surgical debridement, or explantation.	30 days from time of implantation
Limb Salvage Rate at Day 30 in the All HAV Group	Rate of successful limb salvage at the specified milestone post-implantation, evaluated across the entire overall study population who received the Human Acellular Vessel (HAV). Limb salvage is defined as the preservation of the treated upper or lower extremity without the requirement for a major secondary amputation (defined as an amputation performed at or proximal to the wrist or ankle joints) during the follow-up window.	30 Days from time of implantation
Survival Rate at Day 30 in the All HAV Group	Survival at the specified milestone post-implantation, evaluated across the entire overall study population who received the Human Acellular Vessel (HAV). Under While-on-Treatment analysis all cases without any evidence of death are imputed as having survived.	30 Days from time of implantation
Kaplan-Meier Estimates of Long-term Primary Patency in the All HAV Group	Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV primary patency through the 12-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	12 months from time of implantation
Kaplan-Meier Estimates of Long-term Secondary Patency in the All HAV Group	Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 12-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	12 months from time of implantation
Kaplan-Meier Estimate of Long-term Infection-free HAV Rates in the All HAV Group	Time-to-event analysis estimating the long-term cumulative probabilities of Infection-fee HAV rates through the 12-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	12 months from time of implantation
Kaplan-Meier Estimate of Long-term Limb Salvage Rates in the All HAV Group	Time-to-event analysis estimating the long-term cumulative probabilities of limb salvage through the 12-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	12 months from time of implantation
Kaplan-Meier Estimate of Long-term Patient Survival in the All HAV Group	Time-to-event analysis estimating the long-term cumulative probabilities of patient survival through the 12-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	12 months from implantation
Kaplan-Meier Estimate of Long-term Primary Patency Rates in the All HAV Group	Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV primary patency through the 36-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	36 months from time of implantation
Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the All HAV Group	Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 36-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	36 months from time of implantation
Kaplan-Meier Estimate of Long-term Infection-free HAV Rates in the All HAV Group	Time-to-event analysis estimating the long-term cumulative probabilities of infection-free HAV rates through the 36-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	36 months from time of implantation
Kaplan-Meier Estimate of Long-term Limb Salvage Rates in the All HAV Group	Time-to-event analysis estimating the long-term cumulative probabilities of limb salvage through the 36-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	36 months from time of implantation
Kaplan-Meier Estimate of Long-term Patient Survival in the All HAV Group	Time-to-event analysis estimating the long-term cumulative probabilities of patient survival through the 36-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	36 months from implantation
HAV Interventions Required to Maintain/Restore Patency in the All HAV Group	Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.	30 days from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the All HAV Group	Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.	12 months from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the All HAV Group	Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.	36 months from time of implantation
Secondary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the Extremity Community-Acquired Trauma Subgroup	Rate of secondary patency at 30 days post-implantation, evaluated within the sub-cohort of participants presenting with non-iatrogenic, community-acquired extremity vascular trauma. Secondary 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, including vessels that became occluded but were successfully restored to patency via intervening endovascular or surgical re-intervention (e.g., thrombectomy, thrombolysis, or patch angioplasty).	30 days from time of implantation
HAV Infection-free Rates at Day 30 in the Extremity Community-Acquired Trauma Subgroup	The percentage of participants who remained entirely free from a confirmed, adjudicated infection of the implanted Human Acellular Vessel (HAV) conduit through the follow-up period. An infection event is defined by clinical signs (e.g., localized purulence, exposed graft, erythema) coupled with microbiologic confirmation from wound/perigraft cultures, or an independent clinical adjudication confirming a graft-specific infectious complication requiring targeted antibiotic therapy, surgical debridement, or explantation. Participants who did not experience an adjudicated graft infection are considered infection-free.	30 days from time of implantation
Limb Salvage Rate at Day 30 in the Extremity Community-Acquired Trauma Subgroup	Rate of successful limb salvage at 30 days post-implantation, evaluated within the sub-cohort of participants presenting with non-iatrogenic, community-acquired extremity vascular trauma. Limb salvage is defined as the preservation of the treated upper or lower extremity without the requirement for a major secondary amputation (defined as an amputation performed at or proximal to the wrist or ankle joints) during the 30-day follow-up window.	30 Days from time of implantation
Survival Rate at Day 30 in the Extremity Community-Acquired Trauma Subgroup	Survival at 30 days post-implantation, evaluated within the sub-cohort of participants presenting with non-iatrogenic, community-acquired extremity vascular trauma. Under While-on-Treatment analysis all cases without any evidence of death are imputed as having survived.	30 Days from time of implantation
Kaplan-Meier Estimates of Long-term Primary Patency in the Extremity Community-Acquired Trauma Subgroup	Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV primary patency through the 12-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	12 months from time of implantation
Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the Extremity Community Acquired Injury Trauma Subgroup	Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 12-month follow-up period, evaluated across the Extremity Community Acquired Injury Trauma Subgroup. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	12 months from time of implantation
Kaplan-Meier Estimates of Infection-free HAV Rates in the Extremity Community-Acquired Trauma Subgroup	Time-to-event analysis estimating the long-term cumulative probabilities of Infection-free HAV rates through the 12-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	12 months from time of implantation
Kaplan-Meier Estimates of Limb Salvage Rates in the Extremity Community-Acquired Trauma Subgroup	Time-to-event analysis estimating the long-term cumulative probabilities of limb salvage rates through the 12-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	12 months from time of implantation
Kaplan-Meier Estimates of Patient Survival in the Extremity Community-Acquired Trauma Subgroup	Time-to-event analysis estimating the long-term cumulative probabilities of patient survival through the 12-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	12 months from time of implantation
Kaplan-Meier Estimates of Long-term Primary Patency in the Extremity Community-Acquired Trauma Subgroup	Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV primary patency through the 36-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	36 months from time of implantation
Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the Extremity Community Acquired Injury Trauma Subgroup	Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 36-month follow-up period, evaluated across the Extremity Community Acquired Injury Trauma Subgroup. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	36 months from time of implantation
Kaplan-Meier Estimates of Infection-free HAV Rates in the Extremity Community-Acquired Trauma Subgroup	Time-to-event analysis estimating the long-term cumulative probabilities of Infection-free HAV rates through the 36-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	36 months from time of implantation
Kaplan-Meier Estimates of Limb Salvage Rates in the Extremity Community-Acquired Trauma Subgroup	Time-to-event analysis estimating the long-term cumulative probabilities of limb salvage rates through the 36-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	36 months from time of implantation
Kaplan-Meier Estimates of Patient Survival in the Extremity Community-Acquired Trauma Subgroup	Time-to-event analysis estimating the long-term cumulative probabilities of patient survival through the 36-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.	36 months from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup	Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.	30 days from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup	Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.	12 months from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup	Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.	36 months from time of implantation

Collaborators and Investigators

• Sponsor: Humacyte, Inc.
• Collaborators: U.S. Army Medical Research and Development Command; Atlantic Research Group
• Investigators: Study Director: Shamik Parikh, MD, Humacyte, Inc.

Publications and helpful links

General Publications

• Lum Y, Moore EE, Kundi R, Morrison J, Shores JT, Niklason LE, Parikh S. Bioengineered human blood vessels to treat hospital-acquired vascular complications. J Vasc Surg Cases Innov Tech. 2025 Sep 8;11(6):101976. doi: 10.1016/j.jvscit.2025.101976. eCollection 2025 Dec.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): September 19, 2023
• Study Completion (Actual): May 15, 2026

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: December 23, 2016
• First Posted (Estimated): December 29, 2016

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Vascular System Injuries
• Other Study ID Numbers: CLN-PRO-V005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No