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NCT03999424 · ClinicalTrials.gov registry record · Phase 1
Autologous Human Schwann Cells in Peripheral Nerve Repair
A Phase 1 study, sponsored by W. Dalton Dietrich.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT03999424: Completed Phase 1 study, sponsored by W. Dalton Dietrich.
NCT03999424 is a Phase 1 study that has completed, run by W. Dalton Dietrich. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03999424, a Phase 1 study, has completed, sponsored by W. Dalton Dietrich.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study 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). 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.
Primary Outcome
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.
Interventions
- BIOLOGICAL autologous human Schwann cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-09-24 |
| Est. Completion | 2025-12-04 |
| Phase | Phase 1 |
What the finished NCT03999424 record still lists
NCT03999424 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which autologous human Schwann cells is the first listed.
NCT03999424 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03999424 about?
NCT03999424 is a clinical study titled "Autologous Human Schwann Cells in Peripheral Nerve Repair". 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 p...
What is the current status of trial NCT03999424?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2019-09-24. Estimated completion is 2025-12-04.
What interventions are being tested in trial NCT03999424?
The interventions under investigation include: autologous human Schwann cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT03999424?
This trial is sponsored by W. Dalton Dietrich, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03999424's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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