Expanded Access for Single Patient Treatment of Autologous Human Schwann Cells (ahSC) for Peripheral Nerve Repair
1 other identifier
expanded_access
N/A
1 country
1
Brief Summary
The primary purpose of this research study is to determine the safety of injecting ones own Schwann cells as a supplement along with nerve autograft (eg sural nerve) a few weeks after a severe injury to the sciatic nerve has occurred.
Trial Health
Trial Health Score
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2015
CompletedFirst Posted
Study publicly available on registry
June 25, 2015
CompletedMarch 5, 2019
March 1, 2019
June 21, 2015
March 4, 2019
Conditions
Interventions
Schwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix (Duragen).
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- W. Dalton Dietrichlead
- The Miami Project to Cure Paralysiscollaborator
Study Sites (1)
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Allan Levi, MD, PhD
University of Miami
Study Design
- Study Type
- expanded access
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Neurosurgery
Study Record Dates
First Submitted
June 21, 2015
First Posted
June 25, 2015
Last Updated
March 5, 2019
Record last verified: 2019-03