Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)

Description

The primary purpose of this research study is to evaluate the safety and possible harms of injecting one's own Schwann cells along with nerve auto-graft after a severe injury to a major nerve has occurred.

Conditions

Peripheral Nerve Injury

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Study Overview

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Study Details

Study overview

The primary purpose of this research study is to evaluate the safety and possible harms of injecting one's own Schwann cells along with nerve auto-graft after a severe injury to a major nerve has occurred.

Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)

Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)

Condition
Peripheral Nerve Injury
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami, Miami, Florida, United States, 33136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year;
  • 2. Between the ages of 18 and 65 at last birthday
  • 1. Persons unable to safely undergo an MRI;
  • 2. Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;
  • 3. Persons with severe peripheral nerve injury gap length \> 10 cm;
  • 4. Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve;
  • 5. Pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment;
  • 6. Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
  • 7. History of active substance abuse;
  • 8. Persons allergic to gentamicin;
  • 9. Persons who test positive for HIV or Hepatitis B or C virus.
  • 10. Persons unable to provide consent independently due to cognitive impairment

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

W. Dalton Dietrich,

W. Dalton Dietrich, MD, STUDY_CHAIR, University of Miami

Study Record Dates

2026-09-29