Peripheral Nerve InjuryPhase 1NCT05541250
Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)
A Phase 1 study testing Autologous Human Schwann Cell in people with Peripheral Nerve Injury, run by W. Dalton Dietrich at 1 site in United States.
Trial summary
The primary purpose of this research study is to evaluate the safety and possible harms of injecting one's own Schwann cells along with nerve auto-graft after a severe injury to a major nerve has occurred. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Nerve Injury
- What is being tested?
- Autologous Human Schwann Cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2023to 29 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 nerve injury at the upper or lower extremity within previous year;
- Between the ages of 18 and 65 at last birthday
Who cannot join
- Persons unable to safely undergo an MRI;
- Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;
- Persons with severe peripheral nerve injury gap length > 10 cm;
- 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 enrollment;
- 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.
- Persons unable to provide consent independently due to cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
George Jimsheleishvilli, MD, (305) 2434781, gxj150@med.miami.edu
Allan Levi, MD
About this study
The primary purpose of this research study is to evaluate the safety and possible harms of injecting one's own Schwann cells along with nerve auto-graft after a severe injury to a major nerve has occurred.
- Conditions
- Peripheral Nerve Injury
- Being tested
- Autologous Human Schwann Cell
- 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 CellBiological
A one-time dose of 1000 μl* or 80 to 100 million ahSC prepared from segments of the sural nerve from the leg recovered from the participant.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Human Schwann Cell (ahSC) Group | Experimental | Participants in this group will undergo a sural nerve biopsy followed by ahSC transplant Receives: Biological: Autologous Human Schwann Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-related Adverse Events (AEs)
Safety will be reported as the incidence of treatment-related AEs as assessed by treating physician
Measured: Up to 2 years
Secondary outcomes (3)
Motor Recovery as assessed using the MRC Grading Scale
Motor recovery will be assessed using the Medical Research Council (MRC) Grading Scales. MRC Grading Scale scores ranges from 0-5 with a higher score indicating better function
Measured: Up to 2 years
Sensory recovery as assessed by Pin-Prick Evaluation
Pin prick evaluation will be assessed using the Semmes Weinstein Monofilament Evaluation. Semmes Weinstein Monofilament evaluation has a total score ranging from 0-5 with a higher score indicating better function
Measured: Up to 2 years
Sensory recovery as assessed by the 2-Point Discrimination Evaluation
2-Point Discrimination Evaluation scoring ranges from 2-20mm with a higher score indicating worse function
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start4 May 2023
- Primary completion29 Sep 2027 (estimated)
- Study completion29 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuryStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- W. Dalton Dietrich
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, W. Dalton Dietrich, University of Miami
- Investigators
- W. Dalton Dietrich, MD, Study chair, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541250
- Sponsor's protocol ID
- 20220447
- Other IDs
- OR210075
- Status last verified
- Aug 2026
- First submitted
- 13 Sep 2022
- Last updated
- 29 Sep 2026
- 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)
- ClinicalTrials.gov ID
- NCT05541250
- Acronym / sponsor ID
- 20220447
- Conditions
- Peripheral Nerve Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- W. Dalton DietrichUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 4 May 2023 (actual)
- Primary completion
- 29 Sep 2027 (estimated)
- Study completion
- 29 Sep 2027 (estimated)
- First posted
- 15 Sep 2022 (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 primary purpose of this research study is to evaluate the safety and possible harms of injecting one's own Schwann cells along with nerve auto-graft after a severe injury to a major nerve has occurred.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Human Schwann Cell (ahSC) Group | Experimental | Biological: Autologous Human Schwann CellParticipants in this group will undergo a sural nerve biopsy followed by ahSC transplant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year;
- Between the ages of 18 and 65 at last birthday
Key exclusion criteria (10 listed)
- Persons unable to safely undergo an MRI;
- Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;
- Persons with severe peripheral nerve injury gap length > 10 cm;
- 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 enrollment;
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 CellA one-time dose of 1000 μl* or 80 to 100 million ahSC prepared from segments of the sural nerve from the leg recovered from the participant. | Biological | Autologous Human Schwann Cell (ahSC) Group |
Primary outcome
Incidence of Treatment-related Adverse Events (AEs)
Time frame: Up to 2 years
Safety will be reported as the incidence of treatment-related AEs as assessed by treating physician
3 secondary outcomes
Motor Recovery as assessed using the MRC Grading Scale
Time frame: Up to 2 years
Sensory recovery as assessed by Pin-Prick Evaluation
Time frame: Up to 2 years
Sensory recovery as assessed by the 2-Point Discrimination Evaluation
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- 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.
W. Dalton Dietrich, MD study chair
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 Cell in people with Peripheral Nerve Injury, 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 2 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact George Jimsheleishvilli, MD ((305) 2434781, gxj150@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-related Adverse Events (AEs) (time frame: Up to 2 years). 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 29 Sep 2026.