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

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.

Study Overview

• Status: No longer available
• Conditions: Sciatic Nerve Injury
• Intervention / Treatment: 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 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.

• Study Type: Expanded Access

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Single patient with severe sciatic nerve injury enrolled under emergency request

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: W. Dalton Dietrich
• Collaborators: The Miami Project to Cure Paralysis
• Investigators: Principal Investigator: W. Dalton Dietrich, MD, University of Miami

Study record dates

Study Major Dates

• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: July 15, 2015
• First Submitted That Met QC Criteria: July 26, 2015
• First Posted (Estimate): July 28, 2015

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nerve Injuries
• Other Study ID Numbers: 20150501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No