Surgical treatment for spinal cord injuries using nerve grafts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study evaluates the safety, feasibility, and preliminary efficacy of a surgical approach combining dorsal myelotomy and expansive duraplasty with or without autologous nerve graft implantation in patients with acute traumatic spinal cord injuries. The study involves ten participants who will be randomly assigned to one of two treatment groups, with both participants and assessors blinded to the allocation. The goal is to assess the potential benefits of reducing intraspinal pressure and improving clinical outcomes following spinal cord injury. Additionally, nerve samples will be collected for further analysis to understand the underlying mechanisms of recovery.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Kentucky - Chandler Medical Center
  Lexington, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Francis H Farhadi, MD, PhD — University of Kentucky Neurosurgery
• Study coordinator: Francis H Farhadi, MD, PhD
• Email: francis.farhadi@uky.edu
• Phone: 859-323-5661

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.