Expanded Access - Autologous Human Schwann Cells in Peripheral Nerve Repair

Peripheral Nerve Injuries Clinical Trial

Official title:

Expanded Access - The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT04465929
• Other study ID #: 20190453-EAP
• Status: No longer available

Study information

• Verified date: July 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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).

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Female
• Age group: 16 Years to 16 Years

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Peripheral Nerve Injuries

Intervention

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

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
W. Dalton Dietrich

Country where clinical trial is conducted

United States,