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Autologous Human Schwann Cells in Peripheral Nerve Repair

Primary Purpose

Peripheral Nerve Injuries

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
autologous human Schwann cells
Sponsored by
W. Dalton Dietrich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Peripheral Nerve Injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous human Schwann cells

Arm Description

All participants will receive autologous human Schwann cells harvested from their own sural nerve.

Outcomes

Primary Outcome Measures

Number of participants with reported adverse events (AEs)
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.
Number of participants with reported cell product culture test failure
Using sterility testing, the number of participants with reported cell product culture test failure will be evaluated.
Change in muscle strength scale grade of affected limb muscles
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.
Sensory recovery scale grade of affected dermatomes
Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.
Change in pain scores
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.
Change in pain characteristics (location, intensity, and description)
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.
Number of participants with reported tumorigenesis or unexpected changes in nerve structure
Tumorigenesis and/or unexpected changes in the nerve structure will be determined by evaluation of magnetic resonance imaging (MRI).

Secondary Outcome Measures

Change in muscle strength scale grade of affected limb muscles
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.
Sensory recovery scale grade of affected dermatomes
Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.
Change in pain scores
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.
Change in pain characteristics (location, intensity, and description)
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.
Nerve-graft continuity
Ultrasound will be used to assess nerve-graft continuity.

Full Information

First Posted
June 24, 2019
Last Updated
October 18, 2023
Sponsor
W. Dalton Dietrich
Collaborators
The Miami Project to Cure Paralysis
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1. Study Identification

Unique Protocol Identification Number
NCT03999424
Brief Title
Autologous Human Schwann Cells in Peripheral Nerve Repair
Official Title
The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 24, 2019 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
W. Dalton Dietrich
Collaborators
The Miami Project to Cure Paralysis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nerve Injuries

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous human Schwann cells
Arm Type
Experimental
Arm Description
All participants will receive autologous human Schwann cells harvested from their own sural nerve.
Intervention Type
Biological
Intervention Name(s)
autologous human Schwann cells
Intervention Description
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 Outcome Measure Information:
Title
Number of participants with reported adverse events (AEs)
Description
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.
Time Frame
12 months post-transplantation
Title
Number of participants with reported cell product culture test failure
Description
Using sterility testing, the number of participants with reported cell product culture test failure will be evaluated.
Time Frame
12 months post-transplantation
Title
Change in muscle strength scale grade of affected limb muscles
Description
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.
Time Frame
from baseline to 12 months post-transplantation
Title
Sensory recovery scale grade of affected dermatomes
Description
Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.
Time Frame
from baseline to 12 months post-transplantation
Title
Change in pain scores
Description
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.
Time Frame
from baseline to 12 months post-transplantation
Title
Change in pain characteristics (location, intensity, and description)
Description
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.
Time Frame
from baseline to 12 months post-transplantation
Title
Number of participants with reported tumorigenesis or unexpected changes in nerve structure
Description
Tumorigenesis and/or unexpected changes in the nerve structure will be determined by evaluation of magnetic resonance imaging (MRI).
Time Frame
2 years post-transplantation
Secondary Outcome Measure Information:
Title
Change in muscle strength scale grade of affected limb muscles
Description
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.
Time Frame
from baseline to 5 years
Title
Sensory recovery scale grade of affected dermatomes
Description
Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.
Time Frame
from baseline to 5 years
Title
Change in pain scores
Description
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.
Time Frame
from baseline to 5 years post-transplantation
Title
Change in pain characteristics (location, intensity, and description)
Description
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.
Time Frame
from baseline to 5 months post-transplantation
Title
Nerve-graft continuity
Description
Ultrasound will be used to assess nerve-graft continuity.
Time Frame
2 weeks post-transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Levi, MD, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Autologous Human Schwann Cells in Peripheral Nerve Repair

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