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Clinical Trials/NCT02480777
NCT02480777No Longer AvailableNot Applicable

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

W. Dalton Dietrich1 site in 1 countryStarted: June 25, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
No Longer Available
Sponsor
Locations
1

Study Overview

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.

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.

Study Design

Study Type
Expanded Access

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Investigators

Sponsor
W. Dalton Dietrich
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

W. Dalton Dietrich

Professor of Neurosurgery

University of Miami

Study Sites (1)

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