NCT06243211 Spinal Decompression Plus Nerve Graft Implantation Following TSCI
| NCT ID | NCT06243211 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Francis Farhadi |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-04-19 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-04-19 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: * Age: = 18 years and = 80 years * Written informed consent by patient or legal authorized representative * No other life-threatening injury * No evidence of sepsis * Acute cervical or thoracic SCI with ASIA Impairment Scale grade A or B on admission * Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12 * The ability to undergo surgical intervention including study procedures through a posterior approach within 48 hours of injury Exclusion Criteria: * Unconsciousness or other mental impairment that prevents neurological assessment within the first 48 hours * Acute SCI with ASIA Impairment Scale grade C, D or E * Spinal cord decompression and spinal stabilization can be safely performed through an anterior-only approach (i.e. posterior approach is not required) * Currently involved in another non-observational SCI research study or receiving another investigational drug * Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation (at discretion of the principal investigator) * Unable to commit to the follow-up schedule * A recent history of regular substance abuse (illicit drugs, alcohol), which in the opinion of the investigator would interfere with the subject's participation in the study * Any condition likely to result in the patient's death within the next 12 months * Prisoner * Subjects who in the opinion of the investigator are not suitable for inclusion in the study (reason to be documented). * Pregnancy
Contact & Investigator
Francis H Farhadi, MD, PhD
PRINCIPAL INVESTIGATOR
University of Kentucky Neurosurgery
Frequently Asked Questions
Who can join the NCT06243211 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06243211 currently recruiting?
Yes, NCT06243211 is actively recruiting participants. Contact the research team at francis.farhadi@uky.edu for enrollment information.
Where is the NCT06243211 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT06243211 clinical trial?
NCT06243211 is sponsored by Francis Farhadi. The principal investigator is Francis H Farhadi, MD, PhD at University of Kentucky Neurosurgery. The trial plans to enroll 10 participants.