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Clinical Trial for Severe Peripheral Nerve Injury

Clinical Trial for Severe Peripheral Nerve Injury

Purpose

The primary purpose of this research study is 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 Criteria

 

  • 18 to 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

Exclusion Criteria

 

  • 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

Duration

5 Years

 

Enrollment Open Until

10 participants are enrolled.

 

Principal Investigator/Contact