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RECRUITING
NCT06243211
NA

Spinal Decompression Plus Nerve Graft Implantation Following TSCI

Sponsor: Francis Farhadi

View on ClinicalTrials.gov

Summary

This is a single-blinded (with outcome assessors blinded to treatment allocation), 12-month pilot study to evaluate of the safety, feasibility, and preliminary efficacy of dorsal myelotomy and expansive duraplasty performed either without or with autologous nerve graft implantation after acute traumatic spinal cord injury. Ten participants will be allocated to receive either DMED (n=5) or DMED + ANGI (n=5) based on a block design. Participants and assessors will be blinded to group allocation. Excess sural nerve samples will be collected for banking/analysis (may include proteomic, culturing, genomic, cellular analysis).

Official title: Minimizing Secondary Injury in Patient With SCI Using Expansive Duroplasty

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-04-19

Completion Date

2026-12-31

Last Updated

2025-12-10

Healthy Volunteers

No

Interventions

PROCEDURE

DMED

Decompression of spinal cord with stabilization - posterior approach.

PROCEDURE

ANGI

Implantation of nerve tissue following decompression ans stabilization.

Locations (1)

University of Kentucky - Chandler Medical Center

Lexington, Kentucky, United States