Spinal Decompression Plus Nerve Graft Implantation Following TSCI

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Francis Farhadi
Study ID
NCT06243211
Status
Recruiting
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Conditions

  • Acute Traumatic Spinal Cord Injury
  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • DMED — PROCEDURE
    Decompression of spinal cord with stabilization - posterior approach.
  • ANGI — PROCEDURE
    Implantation of nerve tissue following decompression ans stabilization.

Study Details

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).

Key Dates

Start date
Apr 19, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: DMED
    Dorsal myelotomy and expansive duraplasty (DMED) only.
  • Active Comparator: DMED + ANGI
    Dorsal myelotomy and expansive duraplasty (DMED) and supplemental autologous nerve graft implantation (ANGI).

Primary Outcome Measure

SCIM- Spinal Cord Independence Measures vIII [ Time Frame: Day 84 through day 364 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kentucky - Chandler Medical CenterLexingtonKentucky40536
Francis Farhadi, MD, PhD
[email protected]
859-323-5661
Francis Farhadi, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lexington, KY

By research site
University of Kentucky - Chandler Medical Center· Lexington, KY

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