Recruiting

DMED & ANGI

Sponsor:

Francis Farhadi

Code:

NCT06243211

Conditions

Spinal Cord Injuries

Acute Traumatic Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

DMED

ANGI

Study Details

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).

Conditions

Spinal Cord Injuries

Acute Traumatic Spinal Cord Injury

Study ID

NCT06243211

Start date

Apr 19, 2024

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: DMED

Dorsal myelotomy and expansive duraplasty (DMED) only.

active comparator: DMED + ANGI

Dorsal myelotomy and expansive duraplasty (DMED) and supplemental autologous nerve graft implantation (ANGI).

Interventions

DMED

Decompression of spinal cord with stabilization - posterior approach.

ANGI

Implantation of nerve tissue following decompression ans stabilization.

Primary outcome measure

  • SCIM- Spinal Cord Independence Measures vIII [ Time Frame: Day 84 through day 364 ]
  • AIS (2019) [ Time Frame: Screening through day 364 ]

Central Contacts and Locations

Central contacts

Francis H Farhadi, MD, PhD

859-323-5661francis.farhadi@uky.edu

Harshit Arora, PhD

859-323-4533harshit.arora@uky.edu

Locations

University of Kentucky - Chandler Medical Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Francis Farhadi, MD, PhD

859-323-5661francis.farhadi@uky.edu

Principal Investigator:

Francis Farhadi, MD, PhD

More Information

Sponsor

Francis Farhadi

Last update posted

Dec 10, 2025

Last verified

Dec, 2025

Keywords

  • Decompression
  • Dorsal
  • Duraplasty
  • Myelotomy
  • Nerve Graft

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Francis Farhadi on 2025-12-10.