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

Primary Purpose

Peripheral Nerve Injury

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Autologous Human Schwann Cell
Sponsored by
W. Dalton Dietrich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Peripheral Nerve Injury

Eligibility Criteria

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

Inclusion 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

Exclusion Criteria:

  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

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous Human Schwann Cell (ahSC) Group

Arm Description

Participants in this group will undergo a sural nerve biopsy followed by ahSC transplant

Outcomes

Primary Outcome Measures

Incidence of Treatment-related Adverse Events (AEs)
Safety will be reported as the incidence of treatment-related AEs as assessed by treating physician

Secondary Outcome Measures

Motor Recovery as assessed using the MRC Grading Scale
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
Sensory recovery as assessed by Pin-Prick Evaluation
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
Sensory recovery as assessed by the 2-Point Discrimination Evaluation
2-Point Discrimination Evaluation scoring ranges from 2-20mm with a higher score indicating worse function

Full Information

First Posted
September 13, 2022
Last Updated
May 6, 2023
Sponsor
W. Dalton Dietrich
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT05541250
Brief Title
Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)
Official Title
Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
September 29, 2026 (Anticipated)
Study Completion Date
September 29, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
W. Dalton Dietrich
Collaborators
United States Department of Defense

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 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous Human Schwann Cell (ahSC) Group
Arm Type
Experimental
Arm Description
Participants in this group will undergo a sural nerve biopsy followed by ahSC transplant
Intervention Type
Biological
Intervention Name(s)
Autologous Human Schwann Cell
Intervention Description
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 Outcome Measure Information:
Title
Incidence of Treatment-related Adverse Events (AEs)
Description
Safety will be reported as the incidence of treatment-related AEs as assessed by treating physician
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Motor Recovery as assessed using the MRC Grading Scale
Description
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
Time Frame
Up to 2 years
Title
Sensory recovery as assessed by Pin-Prick Evaluation
Description
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
Time Frame
Up to 2 years
Title
Sensory recovery as assessed by the 2-Point Discrimination Evaluation
Description
2-Point Discrimination Evaluation scoring ranges from 2-20mm with a higher score indicating worse function
Time Frame
Up to 2 years

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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George Jimsheleishvilli, MD
Phone
(305) 2434781
Email
gxj150@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W. Dalton Dietrich, MD
Organizational Affiliation
University of Miami
Official's Role
Study Chair
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Jimsheleishvilli, MD
Phone
305-243-4781
Email
gxj150@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Allan Levi, MD
First Name & Middle Initial & Last Name & Degree
S. Shelby Burks, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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