Trial record 21 of 329 for:    Expanded Access Studies

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

Expanded access is no longer available for this treatment.
The Miami Project to Cure Paralysis
Information provided by (Responsible Party):
W. Dalton Dietrich, University of Miami Identifier:
First received: June 21, 2015
Last updated: July 26, 2015
Last verified: July 2015
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 Intervention
Sciatic Nerve Injury
Biological: Autologous Human Schwann cells

Study Type: Expanded Access     What is Expanded Access?
Official Title: Expanded Access for Single Patient Treatment of Autologous Human Schwann Cells (ahSC) for Peripheral Nerve Repair

Further study details as provided by University of Miami:

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).
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
- single patient with severe sciatic nerve injury enrolled under emergency request
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02480777

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
Principal Investigator: Allan Levi, MD, PhD University of Miami
  More Information

No publications provided

Responsible Party: W. Dalton Dietrich, Professor of Neurosurgery, University of Miami Identifier: NCT02480777     History of Changes
Other Study ID Numbers: 20130722
Study First Received: June 21, 2015
Last Updated: July 26, 2015
Health Authority: United States: Food and Drug Administration processed this record on November 24, 2015