MedTrace Logo

Spinal Decompression Plus Nerve Graft Implantation Following TSCI

NCT06243211 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-10

No results posted yet for this study

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).

Conditions

  • Spinal Cord Injuries
  • Acute Traumatic Spinal Cord Injury

Interventions

PROCEDURE

DMED

Decompression of spinal cord with stabilization - posterior approach.

PROCEDURE

ANGI

Implantation of nerve tissue following decompression ans stabilization.

Sponsors & Collaborators

  • Spinal Cord and Brain Injury Research Center (SCOBIRC)

    collaborator UNKNOWN

  • Francis Farhadi

    lead OTHER

Principal Investigators

  • Francis H Farhadi, MD, PhD · University of Kentucky Neurosurgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-19
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06243211 on ClinicalTrials.gov