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Completed

NCT Number: NCT03999424

Autologous Human Schwann Cells in Peripheral Nerve Repair

The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) augmentation of nerve autograft repair in participants with severe peripheral nerve injury (PNI). For humans with acute severe PNI, the hypothesis is that augmentation of nerve autograft repair with ahSCs can potentially enhance axonal regeneration and myelin repair and thus improve functional recovery.

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Key information

Conditions

Peripheral Nerve Injuries Nervous System Diseases Neuromuscular Diseases 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

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 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;
  • Between the ages of 18 and 65 years at last birthday;

Exclusion criteria

  • 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 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;

Treatment and study plan

autologous human Schwann cells

Biological

Schwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix

Primary outcomes

  1. Number of participants with reported adverse events (AEs)

    Time frame: 12 months post-transplantation

    The number of participants with reported AEs will be evaluated to assess safety. Using CTCAE v4.0 grading scale, all AEs that are Grade 3 or higher with treating physician's attribution of probable or definite relation to intervention will be included.

  2. Number of participants with reported cell product culture test failure

    Time frame: 12 months post-transplantation

    Using sterility testing, the number of participants with reported cell product culture test failure will be evaluated.

  3. Change in muscle strength scale grade of affected limb muscles

    Time frame: from baseline to 12 months post-transplantation

    The Medical Research Council (MRC) scale for muscle strength grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.

  4. Sensory recovery scale grade of affected dermatomes

    Time frame: from baseline to 12 months post-transplantation

    Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.

  5. Change in pain scores

    Time frame: from baseline to 12 months post-transplantation

    The Douleur Neuropathique 4 (DN4) questionnaire estimates the probability of neuropathic pain, based on 10 items. Seven items related to pain quality are based on an interview and 3 items are based on clinical examination.

  6. Change in pain characteristics (location, intensity, and description)

    Time frame: from baseline to 12 months post-transplantation

    Assessed by a pain diagram which identifies areas of pain with descriptors. An intensity scale from 0 (no pain) to 10 (most intense pain imaginable) is used to rate the overall intensity of pain at the time of assessment.

  7. Number of participants with reported tumorigenesis or unexpected changes in nerve structure

    Time frame: 2 years post-transplantation

    Tumorigenesis and/or unexpected changes in the nerve structure will be determined by evaluation of magnetic resonance imaging (MRI).

Secondary outcomes

  1. Change in muscle strength scale grade of affected limb muscles

    Time frame: from baseline to 5 years

    The Medical Research Council (MRC) scale for muscle strength grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.

  2. Sensory recovery scale grade of affected dermatomes

    Time frame: from baseline to 5 years

    Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.

  3. Change in pain scores

    Time frame: from baseline to 5 years post-transplantation

    The Douleur Neuropathique 4 (DN4) questionnaire estimates the probability of neuropathic pain, based on 10 items. Seven items related to pain quality are based on an interview and 3 items are based on clinical examination.

  4. Change in pain characteristics (location, intensity, and description)

    Time frame: from baseline to 5 months post-transplantation

    Assessed by a pain diagram which identifies areas of pain with descriptors. An intensity scale from 0 (no pain) to 10 (most intense pain imaginable) is used to rate the overall intensity of pain at the time of assessment.

  5. Nerve-graft continuity

    Time frame: 2 weeks post-transplantation

    Ultrasound will be used to assess nerve-graft continuity.

Sponsors and collaborators

Lead sponsor

W. Dalton Dietrich

Other

Collaborators

  • The Miami Project to Cure Paralysis

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2019
Registry last updated
Dec 12, 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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