Actively Recruiting
Spinal Decompression Plus Nerve Graft Implantation Following TSCI
Led by Francis Farhadi · Updated on 2025-12-10
10
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
Sponsors
F
Francis Farhadi
Lead Sponsor
S
Spinal Cord and Brain Injury Research Center (SCOBIRC)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Spinal Decompression Plus Nerve Graft Implantation Following TSCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Written informed consent from patient or legal representative
- No other life-threatening injuries
- No signs of sepsis
- Acute cervical or thoracic spinal cord injury with ASIA Impairment Scale grade A or B at admission
- Non-penetrating spinal cord injury at neurologic levels C2 to C8 or T1 to T12
- Able to undergo posterior surgical intervention including study procedures within 48 hours of injury
You will not qualify if you...
- Unconsciousness or mental impairment preventing neurological assessment within 48 hours
- Acute spinal cord injury with ASIA Impairment Scale grade C, D, or E
- Spinal decompression and stabilization can be done safely through an anterior-only approach
- Participation in another non-observational spinal cord injury study or receiving investigational drugs
- Other illnesses or mental disorders that prevent accurate medical or neurological evaluation
- Unable to commit to follow-up schedule
- Recent regular substance abuse interfering with study participation
- Any condition likely to cause death within 12 months
- Prisoner status
- Investigator's judgment deeming participant unsuitable for the study
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Kentucky - Chandler Medical Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
Research Team
F
Francis H Farhadi, MD, PhD
CONTACT
H
Harshit Arora, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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