Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Autologous Human Schwann Cell · 1 trial · 1 indication
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...
Autologous Human Schwann Cell is an investigational cell therapy being studied for the treatment of Peripheral Nerve Injury. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy.
Autologous Human Schwann Cell is being developed by United Therapeutics Corporation, a publicly traded company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting a Phase 1 clinical trial to evaluate the therapy in patients with severe peripheral nerve injury.
Autologous Human Schwann Cell is in Phase 1 clinical development. It is an investigational therapy, not yet approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is actively recruiting participants in the United States to assess the safety and efficacy of the treatment.
Autologous Human Schwann Cell is being evaluated in a single Phase 1 clinical trial with the identifier NCT05541250. This study, titled 'Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI),' is currently recruiting 30 participants in the United States.
Yes, Autologous Human Schwann Cell is also referred to as ahSC, which is an abbreviation used in clinical trial documentation. The ongoing Phase 1 study NCT05541250 uses the term 'ahSC' in its title, confirming that both names refer to the same investigational cell therapy for peripheral nerve injury.