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Spinal Decompression and Nerve Graft for Acute Spinal Cord Injury

This pilot study is looking at new ways to treat acute traumatic spinal cord injury (TSCI). Researchers are testing two surgical approaches: Decompression of spinal cord with stabilization (DMED) alone, or DMED combined with Implantation of nerve tissue (ANGI). The goal is to see if these procedures are safe, possible to perform, and if they show early signs of helping people with spinal cord injuries. You might be able to join if you are between 18 and 80 years old, have a specific type of acute spinal cord injury (ASIA Impairment Scale grade A or B), and don't have other serious injuries or infections. The study will measure your independence and neurological function over about a year to see how well the treatments work. This study aims to enroll 10 participants.

Study design
This is a single-blinded pilot study, meaning outcome assessors won't know which treatment you received. Ten participants will be randomly assigned to one of two treatment groups.
What's involved
You would undergo surgical intervention. Your independence and neurological function will be measured at various times from screening up to day 364.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be followed for up to 364 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06243211

Spinal Decompression Plus Nerve Graft Implantation Following TSCI

Recruiting
NAAges 18–80InterventionalTreatment
Francis Farhadi
~10 participants
Updated 2025-12-10 on ClinicalTrials.gov
What's tested:DMEDANGI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
SCIM- Spinal Cord Independence Measures vIII
Measured over Day 84 through day 364
+1 more outcome measured

Conditions

Spinal Cord Injuries
Acute Traumatic Spinal Cord Injury

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • Francis H Farhadi, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Kentucky Neurosurgery

Who to contact

Francis H Farhadi, MD, PhD
[email protected]
859-323-5661
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • SCIM- Spinal Cord Independence Measures vIIIDay 84 through day 364

    The SCIM has been developed to address three specific areas of function in patients with spinal cord injuries (SCI). It looks at self-care (feeding, grooming, bathing, and dressing), respiration and sphincter management, and a patient's mobility abilities (bed and transfers and indoors/outdoors).

  • AIS (2019)Screening through day 364

    American Spinal Injury Association International standards for neurological classification of spinal cord injury Assessment