RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-04

Study Completion:2026-09-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05541250

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

George Jimsheleishvilli, MD

CONTACT

(305) 2434781

gxj150@med.miami.edu

Principal Investigator

W. Dalton Dietrich, MD

STUDY_CHAIR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: W. Dalton Dietrich

W. Dalton Dietrich, MD, STUDY_CHAIR, 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

Study Start Date2023-05-04

Study Completion Date2026-09-29

Study Record Updates

Study Start Date2023-05-04

Study Completion Date2026-09-29

Terms related to this study

Additional Relevant MeSH Terms

Peripheral Nerve Injury