TraumaNCT05873959
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 study of Trauma and Trauma Injury, run by Humacyte, Inc. at 3 sites in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Trauma, Trauma Injury, Trauma, Multiple
- What is being tested?
- HAV implantation
- How many people
- 17 participants
- Where
- 3 sitesUkraine
- Study dates
- 1 May 2023to 15 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Employees of the sponsor or patients who are employees or relatives of the investigator.
Trial locations and contacts
3 sites in 1 country.
Ukraine3 sites
Municipal Non-Profit Enterprise ""City Clinical Hospital #16" of the Dnipro City Council"
Dnipro
Medical Center LLC "CLINIC VERUM EXPERT"
Kyiv
Communal non-profit enterprise "Vinnytsia Regional Clinical Hospital named after E. Pirogov" of the Vinnytsia Regional Council, center of cardiovascular surgery
Vinnytsia
About this study
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
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
- Being tested
- HAV implantation
- Keywords
- extremities, arterial replacement, arterial reconstruction
- Medical subject headings
- Wounds and Injuries, Accidental Injuries, Multiple Trauma, Wounds, Nonpenetrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAV implantationBiological
HAVs already implanted under humanitarian aid program to repair or reconstruct arteries following an extremity life- or limb-threatening traumatic injury.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of the HAV
To determine the rate of adverse events after impanation
Measured: up to 12 months
Primary patency of the HAV after implantation
To determine the rate of HAV primary patency at 30 days after implantation
Measured: 30 days
Secondary outcomes (4)
Frequency of Adverse Events of Special Interest (AESIs)
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.
Measured: up to 12 months
HAV durability
To determine the time frame when the HAV has not been removed, replaced, or ligated.
Measured: up to 12 months
Rate of affected limb salvage/amputation after implantation
To determine the rate of affected limb salvage/amputation after HAV implantation
Measured: up to 12 months
Patency of the HAV after implantation
To determine the rate of HAV patency (primary, primary assisted, and secondary) after implantation
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 May 2023
- Primary completion26 May 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humacyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873959
- Sponsor's protocol ID
- CLN-PRO-V017
- Status last verified
- Nov 2024
- First submitted
- 16 May 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
- Expanded access
- Available
Publications
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.
PubMed 37213923Moore 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.
PubMed 39565635
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05873959
- Acronym / sponsor ID
- CLN-PRO-V017
- Conditions
- Trauma, Trauma Injury, Trauma, Multiple, Trauma Blunt
- Keywords
- extremities, arterial replacement, arterial reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Humacyte, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Employees of the sponsor or patients who are employees or relatives of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAV implantationHAVs already implanted under humanitarian aid program to repair or reconstruct arteries following an extremity life- or limb-threatening traumatic injury. | Biological | – |
Primary outcome
Safety and tolerability of the HAV
Time frame: up to 12 months
To determine the rate of adverse events after impanation
Primary patency of the HAV after implantation
Time frame: 30 days
To determine the rate of HAV primary patency at 30 days after implantation
4 secondary outcomes
Frequency of Adverse Events of Special Interest (AESIs)
Time frame: up to 12 months
HAV durability
Time frame: up to 12 months
Rate of affected limb salvage/amputation after implantation
Time frame: up to 12 months
Patency of the HAV after implantation
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Background: PubMed 37213923Sokolov 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.
- Results publication: PubMed 39565635Moore 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.
- Lancet Regional Health EuropeLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Trauma Injury, run by Humacyte, Inc. at 3 sites in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of the HAV (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05873959, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.