Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05541250 | Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI) | PHASE1 | RECRUITING | 30 | — | — | May 4, 2023 | Sep 29, 2026 | Sep 2, 2025 | 1 | United States |
Safety will be reported as the incidence of treatment-related AEs as assessed by treating physician
| Arm | Type | Description |
|---|---|---|
| Autologous Human Schwann Cell (ahSC) Group | EXPERIMENTAL | Participants in this group will undergo a sural nerve biopsy followed by ahSC transplant |
| Name | Type | Description |
|---|---|---|
| Autologous Human Schwann Cell | BIOLOGICAL | 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. |
Inclusion Criteria: 1. Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year; 2. Between the ages of 18 and 65 at last birthday Exclusion Criteria: 1. Persons unable to safely undergo an MRI; 2. Persons wit...