Vascular System InjuriesNCT03631056
Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) for Vascular System Injuries
A study testing Acellular Tissue Engineered Vessel (ATEV) / Human Acellular Vessel (HAV) in people with Vascular System Injuries, run by Humacyte, Inc..
Trial summary
Individual patient expanded access requests may be considered for patients who have no other treatment options and are not eligible for an ATEV clinical study Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular System Injuries
- What is being tested?
- Acellular Tissue Engineered Vessel (ATEV) / Human Acellular Vessel (HAV)
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 Any age
- Child, Adult, Older adult
Who may be able to join
- -
Who cannot join
- -
About this study
Individual patient expanded access requests may be considered for patients who have no other treatment options and are not eligible for an ATEV clinical study
Read the detailed description
Procedure for Requesting Expanded Access:
The treating physician requesting expanded access must contact Humacyte directly with the basis for the request. Please include your contact information so that Humacyte may follow up with you directly.
General Criteria:
We will evaluate and respond to each expanded-access request that we receive on a case-by-case basis. Humacyte will consider the nature of the request, the patient's health, the available medical and scientific information about the investigational product, the balance of risk and potential benefit to the patient, the availability of investigational product, and the potential regulatory impact.
Anticipated Timing:
If you contact Humacyte as described above, Humacyte anticipates that we will acknowledge receipt within ten (10) business days or less.
- Conditions
- Vascular System Injuries
- Being tested
- Acellular Tissue Engineered Vessel (ATEV) / Human Acellular Vessel (HAV)
- Medical subject headings
- Vascular System Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Tissue Engineered Vessel (ATEV) / Human Acellular Vessel (HAV)Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular System InjuriesStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Humacyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631056
- Sponsor's protocol ID
- CLN-EA-IP
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2018
- Last updated
- 24 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) for Vascular System Injuries
- ClinicalTrials.gov ID
- NCT03631056
- Acronym / sponsor ID
- CLN-EA-IP
- Conditions
- Vascular System Injuries
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Humacyte, Inc.Industry (pharma, biotech, devices)
- First posted
- 15 Aug 2018 (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.
Individual patient expanded access requests may be considered for patients who have no other treatment options and are not eligible for an ATEV clinical study
Detailed description
Procedure for Requesting Expanded Access:
The treating physician requesting expanded access must contact Humacyte directly with the basis for the request. Please include your contact information so that Humacyte may follow up with you directly.
General Criteria:
We will evaluate and respond to each expanded-access request that we receive on a case-by-case basis. Humacyte will consider the nature of the request, the patient's health, the available medical and scientific information about the investigational product, the balance of risk and potential benefit to the patient, the availability of investigational product, and the potential regulatory impact.
Anticipated Timing:
If you contact Humacyte as described above, Humacyte anticipates that we will acknowledge receipt within ten (10) business days or less.
Study design
Who may qualify
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Acellular Tissue Engineered Vessel (ATEV) / Human Acellular Vessel (HAV) | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Acellular Tissue Engineered Vessel (ATEV) / Human Acellular Vessel (HAV) in people with Vascular System Injuries, run by Humacyte, Inc..
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 1 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: status not confirmed, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
Where can I read the original study information?
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 24 Aug 2025.