Expanded Access - Autologous Human Schwann Cells in Peripheral Nerve Repair

NCT04465929 | Unknown

• 1 other identifier: 20190453-EAP
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Emergency expanded access for a single patient was granted to receive autologous human Schwann cell (ahSC) augmentation of nerve autograft repair after severe peripheral nerve injury (PNI).

Conditions

Peripheral Nerve Injuries

Interventions

Autologous Human Schwann Cells BIOLOGICAL

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

Eligibility Criteria

• Age: 16 Years - 16 Years
• Sex: female
• Age Groups: Child (0-17)

You may qualify if:

• Persons with severe sciatic nerve injury, brachial plexus injury, and/or major injury at the upper or lower extremity with nerve loss within previous year;
• Peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings;

You may not qualify if:

• Persons unable to safely undergo an MRI (may include persons with an implanted device or metallic fragments which may interfere with MRI safety);
• Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest (may include amputation or major injury to lower limb, or disease affecting the sural nerve);
• Persons with severe peripheral nerve injury gap length \> 10 cm in length;
• Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve;
• Pregnant women or a positive pregnancy test in those women with reproductive potential prior to transplantation;
• Presence of disease that might interfere with participant

Sponsors & Collaborators

• W. Dalton Dietrich: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Allan D. Levi, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 10, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Locations

US (1)