Expanded Access - Autologous Human Schwann Cells in Peripheral Nerve Repair

NO_LONGER_AVAILABLE

Conditions studied: Peripheral Nerve Injuries

In brief

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).

Key facts

Study ID

NCT04465929

Run by

W. Dalton Dietrich

Last updated by the study team

2020-07-10

Who can join

Age: 16 and older, up to 16. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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