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Expanded Access - Autologous Human Schwann Cells in Peripheral Nerve Repair

Primary Purpose

Peripheral Nerve Injuries

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Autologous Human Schwann Cells
Sponsored by
W. Dalton Dietrich
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Peripheral Nerve Injuries

Eligibility Criteria

16 Years - 16 Years (Child)Female

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;

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

Sites / Locations

  • University of Miami

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 25, 2020
Last Updated
July 7, 2020
Sponsor
W. Dalton Dietrich
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1. Study Identification

Unique Protocol Identification Number
NCT04465929
Brief Title
Expanded Access - Autologous Human Schwann Cells in Peripheral Nerve Repair
Official Title
Expanded Access - The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)
Study Type
Expanded Access

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
W. Dalton Dietrich

4. Oversight

5. Study Description

Brief Summary
Emergency expanded access for a single patient was granted to receive autologous human Schwann cell (ahSC) augmentation of nerve autograft repair after severe peripheral nerve injury (PNI).

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

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
16 Years
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; 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan D. 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

Learn more about this trial

Expanded Access - Autologous Human Schwann Cells in Peripheral Nerve Repair

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