Spinal Decompression Plus Nerve Graft Implantation Following TSCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFrancis Farhadi
About this trial
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
Qualifiers
Age: = 18 years and = 80 years
Written informed consent by patient or legal authorized representative
No other life-threatening injury
No evidence of sepsis
Disqualifiers
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
Trial design
Treatments tested in this trial
- DMED
- ANGI
Treatment groups
10 Participants
are divided into 2 treatment groupsSponsors and collaborators
Francis Farhadi
Lead sponsor
University of Kentucky
Sponsor institution
Spinal Cord and Brain Injury Research Center (SCOBIRC)
Collaborator
Source ClinicalTrials.gov