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Lab-Grown vessel could save Teens' limbs after severe injury

NCT ID NCT07762313

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial tests whether a lab-grown blood vessel called SYMVESS can safely repair damaged arteries in the arms or legs of adolescents when their own veins aren't suitable. The study enrolls teens up to age 17 with severe arterial injuries that threaten limb loss. Participants receive the vessel implant and are monitored for a year to check how well it stays open, prevents infection, and avoids amputation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Acellular Tissue Engineered Vessel (Symvess), a lab-grown blood vessel made from human cells that is implanted to replace a damaged artery.
What this could lead to
If successful, this could provide a safe, ready-made option for repairing severe limb artery injuries in adolescents, potentially reducing amputations and improving recovery.
What could go wrong
This is a small early-stage trial, and the vessel may fail to stay open, become infected, or cause side effects. Long-term safety and effectiveness are not yet established.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients 17 years of age or younger who have reached adult sexual maturity (i.e., Tanner Sexual Maturity Rating Stage 5) as determined by the Investigator a. For purposes of this study, Tanner Stage 5 is defined for both males and females as having pubic hair that extends beyond the inguinal crease onto the thigh 2. Patients with extremity arterial injury requiring urgent revascularization to avoid imminent limb loss 3. Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6mm SYMVESS per the judgment of the treating surgeon, taking into account vasoconstriction and situational inflow and outflow considerations 4. Autologous vein graft is either not feasible, in the judgment of the treating surgeon (e.g. because of lack of availability of suitable conduit) or is not desirable because of the urgency of revascularization 5. Patient and parent/legal representative are able to communicate meaningfully with investigative staff and able to comply with study procedures and visits. 6. Patient is able and willing to provide informed assent and parent (or legal representative) is able and willing to provide informed consent prior to treatment with SYMVESS 7. Life expectancy of at least 1 year based on clinical assessment by the Investigator Exclusion Criteria: 1. Limb at high risk of amputation despite vascular reconstruction evidenced by Mangled Extremity Severity Score (MESS) of ≥ 7 2. Injury Severity Score (ISS) \>60 3. Known pregnant females 4. Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries 5. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SYMVESS 6. Previous exposure to SYMVESS 7. Known participation in any investigational study within the last 30 days 8. Employees of the sponsor or patients who are employees or relatives of the Investigator

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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