Peripheral Nerve InjuriesPhase 1NCT03999424
Autologous Human Schwann Cells in Peripheral Nerve Repair
A Phase 1 study testing autologous human Schwann cells in people with Peripheral Nerve Injuries, run by W. Dalton Dietrich at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) augmentation of nerve autograft repair in participants with severe peripheral nerve injury (PNI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Nerve Injuries
- What is being tested?
- autologous human Schwann cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2019to 4 Dec 2025
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- History of active substance abuse;
- Persons allergic to gentamicin;
- Persons who test positive for HIV or Hepatitis B or C virus;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)
The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) augmentation of nerve autograft repair in participants with severe peripheral nerve injury (PNI). For humans with acute severe PNI, the hypothesis is that augmentation of nerve autograft repair with ahSCs can potentially enhance axonal regeneration and myelin repair and thus improve functional recovery.
- Conditions
- Peripheral Nerve Injuries
- Being tested
- autologous human Schwann cells
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous human Schwann cellsBiological
Schwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix
| Study group | Role | What they receive |
|---|---|---|
| Autologous human Schwann cells | Experimental | All participants will receive autologous human Schwann cells harvested from their own sural nerve. Receives: Biological: autologous human Schwann cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with reported adverse events (AEs)
The number of participants with reported AEs will be evaluated to assess safety. Using CTCAE v4.0 grading scale, all AEs that are Grade 3 or higher with treating physician's attribution of probable or definite relation to intervention will be included.
Measured: 12 months post-transplantation
Number of participants with reported cell product culture test failure
Using sterility testing, the number of participants with reported cell product culture test failure will be evaluated.
Measured: 12 months post-transplantation
Change in muscle strength scale grade of affected limb muscles
The Medical Research Council (MRC) scale for muscle strength grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.
Measured: from baseline to 12 months post-transplantation
Sensory recovery scale grade of affected dermatomes
Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.
Measured: from baseline to 12 months post-transplantation
Change in pain scores
The Douleur Neuropathique 4 (DN4) questionnaire estimates the probability of neuropathic pain, based on 10 items. Seven items related to pain quality are based on an interview and 3 items are based on clinical examination.
Measured: from baseline to 12 months post-transplantation
Change in pain characteristics (location, intensity, and description)
Assessed by a pain diagram which identifies areas of pain with descriptors. An intensity scale from 0 (no pain) to 10 (most intense pain imaginable) is used to rate the overall intensity of pain at the time of assessment.
Measured: from baseline to 12 months post-transplantation
Number of participants with reported tumorigenesis or unexpected changes in nerve structure
Tumorigenesis and/or unexpected changes in the nerve structure will be determined by evaluation of magnetic resonance imaging (MRI).
Measured: 2 years post-transplantation
Secondary outcomes (5)
Change in muscle strength scale grade of affected limb muscles
The Medical Research Council (MRC) scale for muscle strength grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.
Measured: from baseline to 5 years
Sensory recovery scale grade of affected dermatomes
Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.
Measured: from baseline to 5 years
Change in pain scores
The Douleur Neuropathique 4 (DN4) questionnaire estimates the probability of neuropathic pain, based on 10 items. Seven items related to pain quality are based on an interview and 3 items are based on clinical examination.
Measured: from baseline to 5 years post-transplantation
Change in pain characteristics (location, intensity, and description)
Assessed by a pain diagram which identifies areas of pain with descriptors. An intensity scale from 0 (no pain) to 10 (most intense pain imaginable) is used to rate the overall intensity of pain at the time of assessment.
Measured: from baseline to 5 months post-transplantation
Nerve-graft continuity
Ultrasound will be used to assess nerve-graft continuity.
Measured: 2 weeks post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start24 Sep 2019
- Primary completion4 Dec 2025
- Study completion4 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- W. Dalton Dietrich
- Sponsor type
- University, hospital or other
- Collaborators
- The Miami Project to Cure Paralysis
- Responsible party
- Sponsor-investigator, W. Dalton Dietrich, University of Miami
- Investigators
- Allan Levi, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999424
- Sponsor's protocol ID
- 20190453
- Status last verified
- Dec 2025
- First submitted
- 24 Jun 2019
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)
- ClinicalTrials.gov ID
- NCT03999424
- Acronym / sponsor ID
- 20190453
- Conditions
- Peripheral Nerve Injuries
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- W. Dalton DietrichUniversity, hospital or other
- Collaborators
- The Miami Project to Cure Paralysis
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 4 Dec 2025 (actual)
- First posted
- 26 Jun 2019 (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.
The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) augmentation of nerve autograft repair in participants with severe peripheral nerve injury (PNI). For humans with acute severe PNI, the hypothesis is that augmentation of nerve autograft repair with ahSCs can potentially enhance axonal regeneration and myelin repair and thus improve functional recovery.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous human Schwann cells | Experimental | Biological: autologous human Schwann cellsAll participants will receive autologous human Schwann cells harvested from their own sural nerve. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
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 |
|---|---|---|
| autologous human Schwann cellsSchwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix | Biological | Autologous human Schwann cells |
Primary outcome
Number of participants with reported adverse events (AEs)
Time frame: 12 months post-transplantation
The number of participants with reported AEs will be evaluated to assess safety. Using CTCAE v4.0 grading scale, all AEs that are Grade 3 or higher with treating physician's attribution of probable or definite relation to intervention will be included.
Number of participants with reported cell product culture test failure
Time frame: 12 months post-transplantation
Using sterility testing, the number of participants with reported cell product culture test failure will be evaluated.
Change in muscle strength scale grade of affected limb muscles
Time frame: from baseline to 12 months post-transplantation
The Medical Research Council (MRC) scale for muscle strength grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.
Sensory recovery scale grade of affected dermatomes
Time frame: from baseline to 12 months post-transplantation
Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.
Change in pain scores
Time frame: from baseline to 12 months post-transplantation
The Douleur Neuropathique 4 (DN4) questionnaire estimates the probability of neuropathic pain, based on 10 items. Seven items related to pain quality are based on an interview and 3 items are based on clinical examination.
Change in pain characteristics (location, intensity, and description)
Time frame: from baseline to 12 months post-transplantation
Assessed by a pain diagram which identifies areas of pain with descriptors. An intensity scale from 0 (no pain) to 10 (most intense pain imaginable) is used to rate the overall intensity of pain at the time of assessment.
Number of participants with reported tumorigenesis or unexpected changes in nerve structure
Time frame: 2 years post-transplantation
Tumorigenesis and/or unexpected changes in the nerve structure will be determined by evaluation of magnetic resonance imaging (MRI).
5 secondary outcomes
Change in muscle strength scale grade of affected limb muscles
Time frame: from baseline to 5 years
Sensory recovery scale grade of affected dermatomes
Time frame: from baseline to 5 years
Change in pain scores
Time frame: from baseline to 5 years post-transplantation
Change in pain characteristics (location, intensity, and description)
Time frame: from baseline to 5 months post-transplantation
Nerve-graft continuity
Time frame: 2 weeks post-transplantation
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 12 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Allan Levi, MD, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing autologous human Schwann cells in people with Peripheral Nerve Injuries, run by W. Dalton Dietrich at 1 site in United States.
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 9 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 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of participants with reported adverse events (AEs) (time frame: 12 months post-transplantation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 12 Dec 2025.