Emergent Expanded Access for ahSC Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury.

Sciatic Nerve Injury Clinical Trial

Official title:

Emergent Expanded Access to Use Autologous Human Schwann Cell Augmentation of Nerve Autograft Repair in a Single Patient With Severe Peripheral Nerve Injury

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02510079
• Other study ID #: 20150501
• Status: No longer available

Study information

• Verified date: November 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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 from a relatively small segment of sensory nerve. 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Female
• Age group: 18 Years to 65 Years
• Eligibility: Single patient with severe sciatic nerve injury enrolled under emergency request

Related Conditions & MeSH terms

• Peripheral Nerve Injuries
• Sciatic Nerve Injury
• Wounds and Injuries

Intervention

Biological:
• Autologous human Schwann cells
Schwann cells harvested from the sural nerve will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix (Duragen).

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
W. Dalton Dietrich	The Miami Project to Cure Paralysis

Country where clinical trial is conducted

United States,