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Expanded Access - Autologous Human Schwann Cells in Peripheral Nerve Repair

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ClinicalTrials.gov Identifier: NCT04465929
Expanded Access Status : No longer available
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
W. Dalton Dietrich, University of Miami

Study Description
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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).

Condition or disease Intervention/treatment
Peripheral Nerve Injuries Biological: Autologous Human Schwann Cells

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: Expanded Access - The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Biological: Autologous Human Schwann Cells
    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
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 16 Years   (Child)
Sexes Eligible for Study:   Female
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465929


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
W. Dalton Dietrich
Investigators
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Principal Investigator: Allan D. Levi, MD, PhD University of Miami
More Information
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Responsible Party: W. Dalton Dietrich, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04465929    
Other Study ID Numbers: 20190453-EAP
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Peripheral Nerve Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries