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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
DMED
Procedure/SurgeryDecompression of spinal cord with stabilization - posterior approach.
ANGI
Procedure/SurgeryImplantation of nerve tissue following decompression ans stabilization.
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: DMEDActive comparator 1 intervention
Group B: DMED + ANGIActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
SCIM- Spinal Cord Independence Measures vIII
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).
Time frame
Day 84 through day 3642
AIS (2019)
American Spinal Injury Association International standards for neurological classification of spinal cord injury Assessment
Time frame
Screening through day 364Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Francis Farhadi
Lead sponsor
University of Kentucky
Sponsor institution
Spinal Cord and Brain Injury Research Center (SCOBIRC)
Collaborator
Source ClinicalTrials.gov