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NCT Number: NCT05541250

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

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.

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Key information

Conditions

Peripheral Nerve Injury Nervous System Diseases Neuromuscular Diseases Peripheral Nerve Injuries Peripheral Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Allan Levi, MD

PRINCIPAL_INVESTIGATOR

George Jimsheleishvilli, MD

CONTACT

[email protected]

(305) 2434781

S. Shelby Burks, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year;
  • Between the ages of 18 and 65 at last birthday

Exclusion criteria

  • Persons unable to safely undergo an MRI;
  • Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;
  • Persons with severe peripheral nerve injury gap length > 10 cm;
  • 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 enrollment;
  • Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
  • History of active substance abuse;
  • Persons allergic to gentamicin;
  • Persons who test positive for HIV or Hepatitis B or C virus.
  • Persons unable to provide consent independently due to cognitive impairment

Treatment and study plan

Autologous Human Schwann Cell

Biological

A one-time dose of 1000 μl* or 80 to 100 million ahSC prepared from segments of the sural nerve from the leg recovered from the participant.

Primary outcomes

  1. Incidence of Treatment-related Adverse Events (AEs)

    Time frame: Up to 2 years

    Safety will be reported as the incidence of treatment-related AEs as assessed by treating physician

Secondary outcomes

  1. Motor Recovery as assessed using the MRC Grading Scale

    Time frame: Up to 2 years

    Motor recovery will be assessed using the Medical Research Council (MRC) Grading Scales. MRC Grading Scale scores ranges from 0-5 with a higher score indicating better function

  2. Sensory recovery as assessed by Pin-Prick Evaluation

    Time frame: Up to 2 years

    Pin prick evaluation will be assessed using the Semmes Weinstein Monofilament Evaluation. Semmes Weinstein Monofilament evaluation has a total score ranging from 0-5 with a higher score indicating better function

  3. Sensory recovery as assessed by the 2-Point Discrimination Evaluation

    Time frame: Up to 2 years

    2-Point Discrimination Evaluation scoring ranges from 2-20mm with a higher score indicating worse function

Study contacts

Contact information is provided by the study sponsor or research team.

George Jimsheleishvilli, MD

CONTACT

[email protected]

(305) 2434781

Sponsors and collaborators

Lead sponsor

W. Dalton Dietrich

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2022
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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