- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02480777
Expanded Access for Single Patient Treatment of Autologous Human Schwann Cells (ahSC) for Peripheral Nerve Repair
March 4, 2019 updated by: W. Dalton Dietrich
The primary purpose of this research study is to determine the safety of injecting ones own Schwann cells as a supplement along with nerve autograft (eg sural nerve) a few weeks after a severe injury to the sciatic nerve has occurred.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Detailed Description
The secondary purpose of this research project is to evaluate whether transplanted Schwann cells can enhance recovery of sensory and motor function.
Emergency expanded access for a single patient was granted, as the patient was an ideal candidate for sural nerve repair augmented by autologous Schwann cells which could be harvested either from a relatively small segment of sensory nerve or as in this case from local debridement of injured nerve at the epicenter of the nerve injury.
The cells were expanded using cell culture techniques and placed along with the sural nerve grafts wrapped by an FDA approved collagen matrix (Duragen).
This study is being conducted at the Jackson Memorial and the University of Miami health systems.
As a research subject the patient will be in this study for a total of 5 years from the date receiving Schwann cell transplant augmentation of sural nerve autografts.
Study Type
Expanded Access
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 Miller School of Medicine
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
- single patient with severe sciatic nerve injury enrolled under emergency request
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
Collaborators
Investigators
- Principal Investigator: Allan 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 21, 2015
First Submitted That Met QC Criteria
June 24, 2015
First Posted (Estimate)
June 25, 2015
Study Record Updates
Last Update Posted (Actual)
March 5, 2019
Last Update Submitted That Met QC Criteria
March 4, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 20130722
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 Sciatic Nerve Injury
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W. Dalton DietrichThe Miami Project to Cure ParalysisNo longer availableSciatic Nerve InjuryUnited States
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Peking Union Medical College HospitalUnknownThe Difference in Duration of Sciatic Nerve Block Between Diabetic and Non-diabetic Patients (DSNBD)Sciatic Nerve BlockChina
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Asan Medical CenterCompleted
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Ain Shams UniversityCompletedSciatic Nerve Block
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Mogilev Regional Clinical HospitalCompletedUltrasonography | Sciatic Nerve | Nerve Block | EfficiencyBelarus
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Universidad de MurciaCompletedSciatic Nerve | Flexibility | Hamstring MusclesSpain
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University of California, San DiegoFerrosan Medical Devices, Roskilde, DenmarkCompletedRegional Anesthesia | Sciatic Nerve BlockUnited States
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ASST Gaetano Pini-CTOCompletedUS-guided Sciatic Nerve BlockItaly
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Mogilev Regional Clinical HospitalCompletedUltrasonography | Sciatic Nerve | Nerve Block | Efficiency | Minimum Effective DoseBelarus
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 DietrichNo longer availablePeripheral Nerve InjuriesUnited States
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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 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