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Expanded Access for Single Patient Treatment of Autologous Human Schwann Cells (ahSC) for Peripheral Nerve Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02480777
Expanded Access Status : No longer available
First Posted : June 25, 2015
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
The Miami Project to Cure Paralysis
Information provided by (Responsible Party):
W. Dalton Dietrich, University of Miami

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.

Condition or disease Intervention/treatment
Sciatic Nerve Injury Biological: Autologous Human Schwann cells

Detailed Description:
The secondary purpose of this research project is to evaluate whether transplanted Schwann cells can enhance recovery of sensory and motor function. Emergency expanded access for a single patient was granted, as the patient was an ideal candidate for sural nerve repair augmented by autologous Schwann cells which could be harvested either from a relatively small segment of sensory nerve or as in this case from local debridement of injured nerve at the epicenter of the nerve injury. The cells were expanded using cell culture techniques and placed along with the sural nerve grafts wrapped by an FDA approved collagen matrix (Duragen). This study is being conducted at the Jackson Memorial and the University of Miami health systems. As a research subject the patient will be in this study for a total of 5 years from the date receiving Schwann cell transplant augmentation of sural nerve autografts.

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Study Type : Expanded Access
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access for Single Patient Treatment of Autologous Human Schwann Cells (ahSC) for Peripheral Nerve Repair

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: Autologous Human Schwann cells
    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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria
- single patient with severe sciatic nerve injury enrolled under emergency request

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480777


Locations
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United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
W. Dalton Dietrich
The Miami Project to Cure Paralysis
Investigators
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Principal Investigator: Allan Levi, MD, PhD University of Miami

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Responsible Party: W. Dalton Dietrich, Professor of Neurosurgery, University of Miami
ClinicalTrials.gov Identifier: NCT02480777    
Other Study ID Numbers: 20130722
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019