Spinal Decompression Plus Nerve Graft Implantation Following TSCI

Description

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

Spinal Cord Injuries, Acute Traumatic Spinal Cord Injury

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Study Overview

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Study Details

Study overview

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).

Evaluation 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

Spinal Decompression Plus Nerve Graft Implantation Following TSCI

Condition
Spinal Cord Injuries
Intervention / Treatment

-

Contacts and Locations

Lexington

University of Kentucky - Chandler Medical Center, Lexington, Kentucky, United States, 40536

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age: = 18 years and = 80 years
  • 2. Written informed consent by patient or legal authorized representative
  • 3. No other life-threatening injury
  • 4. No evidence of sepsis
  • 5. Acute cervical or thoracic SCI with ASIA Impairment Scale grade A or B on admission
  • 6. Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12
  • 7. The ability to undergo surgical intervention including study procedures through a posterior approach within 48 hours of injury
  • 1. Unconsciousness or other mental impairment that prevents neurological assessment within the first 48 hours
  • 2. Acute SCI with ASIA Impairment Scale grade C, D or E
  • 3. Spinal cord decompression and spinal stabilization can be safely performed through an anterior-only approach (i.e. posterior approach is not required)
  • 4. Currently involved in another non-observational SCI research study or receiving another investigational drug
  • 5. Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation (at discretion of the principal investigator)
  • 6. Unable to commit to the follow-up schedule
  • 7. 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
  • 8. Any condition likely to result in the patient's death within the next 12 months
  • 9. Prisoner
  • 10. Subjects who in the opinion of the investigator are not suitable for inclusion in the study (reason to be documented).
  • 11. Pregnancy

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

H. Francis Farhadi,

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

Study Record Dates

2026-12-31