Emergent Expanded Access for ahSC Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury.
Emergent Expanded Access to Use Autologous Human Schwann Cell Augmentation of Nerve Autograft Repair in a Single Patient With Severe Peripheral Nerve Injury
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 to augment sural nerve autografts after a severe, non-lacerating injury to the sciatic nerve has occurred.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2015
CompletedFirst Posted
Study publicly available on registry
July 28, 2015
CompletedNovember 16, 2021
November 1, 2021
July 15, 2015
November 15, 2021
Conditions
Interventions
Schwann cells harvested from the sural nerve 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
Miami, Florida, 33136, United States
Study Officials
- PRINCIPAL INVESTIGATOR
W. Dalton Dietrich, MD
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
July 15, 2015
First Posted
July 28, 2015
Last Updated
November 16, 2021
Record last verified: 2021-11