Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)
Recruiting
Phase 1
Interventional Study
Peripheral Nerve Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 30 (estimated)
- Sponsor
- W. Dalton Dietrich · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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…
Contacts