- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04465929
Expanded Access - Autologous Human Schwann Cells in Peripheral Nerve Repair
July 7, 2020 updated by: W. Dalton Dietrich
Expanded Access - The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)
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).
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 16 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Allan D. Levi, MD, PhD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
June 25, 2020
First Submitted That Met QC Criteria
July 7, 2020
First Posted (Actual)
July 10, 2020
Study Record Updates
Last Update Posted (Actual)
July 10, 2020
Last Update Submitted That Met QC Criteria
July 7, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20190453-EAP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Nerve Injuries
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Silk Biomaterials srlUnknownPeripheral Nerve Injury Digital Nerve HandSwitzerland
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University Hospital, Basel, SwitzerlandCompletedPeripheral Nerve Injury Digital Nerve Hand LeftSwitzerland
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Major Extremity Trauma Research ConsortiumActive, not recruitingPeripheral Nerve Injury(Ies)United States
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University of Sao PauloConselho Nacional de Desenvolvimento Científico e TecnológicoCompletedMedian Nerve Disease | Ulnar Nerve Disease | Peripheral Nerve DiseaseBrazil
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BG Trauma Center TuebingenCompletedPeripheral Nerve Injury Upper Limb
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Brooke Army Medical CenterWalter Reed National Military Medical Center; Curtis National Hand Center at... and other collaboratorsUnknown
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Washington University School of MedicineNational Institute of Neurological Disorders and Stroke (NINDS)RecruitingHealthy | Peripheral Nerve Injury Upper LimbUnited States
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Lund University HospitalRecruitingNerve Injury | Peripheral Nerve InjuriesSweden
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Checkpoint Surgical Inc.Congressionally Directed Medical Research ProgramsRecruitingNerve Injury | Peripheral Nerve Injuries | Nerve Palsy | Peripheral Nerve Injury Upper LimbUnited States
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Kocaeli UniversityCompletedPeripheral Nerve Injury, Virtual Reality, RehabilitationTurkey
Clinical Trials on Autologous Human Schwann Cells
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W. Dalton DietrichThe Miami Project to Cure ParalysisCompletedSpinal Cord Injury | ParaplegiaUnited States
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W. Dalton DietrichThe Miami Project to Cure ParalysisActive, not recruiting
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W. Dalton DietrichThe Miami Project to Cure ParalysisCompletedSpinal Cord Injury | Tetraplegia | Quadriplegia | ParaplegiaUnited States
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W. Dalton DietrichThe Miami Project to Cure ParalysisNo longer availableSciatic Nerve InjuryUnited States
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W. Dalton DietrichThe Miami Project to Cure ParalysisNo longer availableSciatic Nerve InjuryUnited States
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W. Dalton DietrichUnited States Department of DefenseRecruitingPeripheral Nerve InjuryUnited States
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FUJIFILM Toyama Chemical Co., Ltd.Active, not recruiting
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Aryn KnightM.D. Anderson Cancer Center; The University of Texas Health Science Center,... and other collaboratorsWithdrawn
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University of MiamiThe Emmes Company, LLCCompletedStem Cell Transplantation | Ventricular Dysfunction, LeftUnited States
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TrichoScience Innovations, Inc.PRA Health Sciences; Pharmalog Institut für klinische Forschung GmbH (PHARMALOG... and other collaboratorsCompletedAndrogenetic AlopeciaGeorgia