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Could your own nerve cells help heal severe injuries?

NCT ID NCT03999424

Disease control Sponsor: W. Dalton Dietrich Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tested whether adding a patient's own Schwann cells (nerve-supporting cells) to a nerve graft could safely improve recovery after severe peripheral nerve injury. Five adults with large nerve gaps received the cell-enhanced graft. The main goal was safety, checking for side effects and signs of nerve regrowth.

What this could mean

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

Active substance
autologous human Schwann cells
What this could lead to
If it works, this could point toward a treatment that improves nerve regrowth and function after severe injuries.
What could go wrong
This is a very early Phase 1 safety trial with only 5 people. It is too small to prove effectiveness, and the approach may not work or could cause side effects like pain or nerve changes.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

5 people

The number who actually took part.

Started

Sep 2019

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 65 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: * Persons with severe sciatic nerve injury, brachial plexus injury, and/or major injury at the upper or lower extremity with nerve loss within previous year; * Peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings; * Between the ages of 18 and 65 years at last birthday; Exclusion Criteria: * Persons unable to safely undergo an MRI (may include persons with an implanted device or metallic fragments which may interfere with MRI safety); * Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest (may include amputation or major injury to lower limb, or disease affecting the sural nerve); * Persons with severe peripheral nerve injury gap length \> 10 cm in length; * Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve; * Pregnant women or a positive pregnancy test in those women with reproductive potential prior to transplantation; * Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study; * History of active substance abuse; * Persons allergic to gentamicin; * Persons who test positive for HIV or Hepatitis B or C virus;

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Conditions

The condition(s) this trial relates to.

Peripheral Nerve Injuries traumatic neuropathy

As listed by the trial registrant

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

Peripheral nerve injuries

Contacts and locations

Locations

  • University of Miami

    Miami, Florida, 33136, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.