CLINICAL TRIALS AND RESEARCH STUDIES CRITERIA FOR PERIPHERAL NERVE INJURY

If you would like to be considered for these or future Miami Project trials or studies, please see our Register for a Research Program section, send us a message, or call The Miami Project Education Office at 305-243-7108.

TRIAL

This is open only to people with severe injury to a peripheral nerve (in leg or arm) and is NOT open to people with a spinal cord injury

The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts after Severe Peripheral Nerve Injury

Purpose: To evaluate the safety of injecting one’s own Schwann cells along with nerve autograft (eg. sural nerve – the sural nerve is a sensory nerve in the leg) after a severe injury to a major nerve has occurred. The secondary purpose of this research project is to evaluate whether transplanted Schwann cells can enhance recovery of sensory and motor function.

Criteria (Inclusion): 18 – 65 years old; severe sciatic nerve injury; brachial plexus injury; and/or major injury of the arm or leg with nerve loss within the previous year.

Criteria (Exclusion): Unable to safely have an MRI, injury to legs that prevents the study doctor from being able to remove part of the sural nerve if needed; severe nerve injury with a gap length greater than 10 mm; history of radiation or cancer in the area of your nerve injury, which includes primary tumors of the nerve; currently pregnant or test positive for pregnancy upon enrollment; disease that the study doctor believes will interfere with participant’s safety or compliance in relation to the study procedures; history of active substance abuse; allergy to gentamicin; positive for HIV or Hepatitis B or C virus.

Study Start Date: September 24, 2019

Estimated Completion Date: September 1, 2029

Status: Enrolling

Principal Investigators: Allan D. Levi, M.D., Ph.D.

WebsiteClinicalTrials.gov

If you would like to be considered for these or future Miami Project trials or studies, please register now!