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Spinal Decompression Plus Nerve Graft Implantation Following TSCI

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv6
  2. Study Status, Eligibilityv5
  3. Lead sponsor: H. Francis Farhadi to Francis Farhadiv4
  4. Start date changed from estimate of Mar 1, 2024 to Apr 19, 2024v3
  5. Lead sponsor: University of Kentucky to H. Francis Farhadi
    • Start date: Jan 31, 2024 to Mar 1, 2024
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06243211
Lead Sponsor Francis Farhadi
Collaborators: Spinal Cord and Brain Injury Research Center (SCOBIRC)
Conditions
(from sponsor)		 Spinal Cord Injuries, Acute Traumatic Spinal Cord Injury
Related terms Spinal Cord Injuries
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov