Spine
Conditions
Interventions
This is a prospective, randomized, controlled, parallel-group, open-label clinical trial without masking, involving 80 adult patients with neurological sequelae secondary to acute or chronic spinal co
Sponsors
Instituto Educacional Jaguary LTDA
Instituto do Osso e da Cartilagem - IOC
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants of both sexes; participants aged 18 years or older; patients with neurological sequelae secondary to traumatic spinal cord injury, clinically diagnosed through specialized neurological examination and/or classified according to Magnetic Resonance Imaging (MRI), as well as neurological injury confirmed by electroneuromyography and/or somatosensory and motor evoked potentials; patients presenting sensory or motor sequelae associated with bladder dysfunction
Exclusion criteria
Exclusion criteria: Patients with neurological deficits of any origin other than traumatic spinal cord injury (cervical, thoracic, or lumbosacral); patients with neurodegenerative diseases that may act as confounding factors in the study data analysis; patients with uncontrolled systemic diseases, such as diabetes, rheumatoid arthritis, hematological disorders, active metabolic diseases, and cardiovascular diseases; patients with active infections, either systemic or at the application site; patients with autoimmune diseases such as juvenile rheumatoid arthritis, scleroderma, among others, or those using immunosuppressive therapy; patients with hemoglobin levels below 11 mg/dL and platelet count below 150,000/mm³; patients with a confirmed history of Guillain-Barré Syndrome, Tay-Sachs disease, Spielmeyer-Vogt-Sjögren-Batten disease (Spielmeyer-Bielschowsky disease), or other infectious, contagious, or inflammatory diseases known to cause central or peripheral neurological alterations; patients with recent (less than 4 weeks) signs, symptoms, or risk factors suggestive of or related to Guillain-Barré Syndrome, such as weakness or tingling sensations (paresthesia), symmetric muscle weakness usually beginning in the lower limbs, absent or reduced deep tendon reflexes in weakened limbs and/or face (facial paralysis), difficulty breathing, difficulty speaking, difficulty swallowing, or difficulty chewing; patients with a recent history of vaccination (less than 6 weeks) against infectious viral diseases; patients with a confirmed history of infection within (less than 4 weeks), or current suspected infection, caused by viruses such as influenza, Zika virus, cytomegalovirus, Epstein-Barr virus, and severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2); patients with recent (less than 6 weeks) administration of vaccines against viral diseases, such as tetanus, influenza, and corona virus disease 2019 (COVID-19); patients with a history of allergy to gangliosides or any excipients in the ganglioside formulation; patients with confirmed diarrhea within (less than 4 weeks), or recent diarrhea suspected to be associated with an infectious disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate improvement in motor and sensory neurological function in patients with neurological sequelae secondary to spinal cord injury undergoing the proposed treatments, using the American Spinal Injury Association (ASIA) Impairment Scale at baseline and at 3, 6, and 12 months after treatment. Changes in motor and sensory scores over time will be assessed, with a positive outcome defined as an increase in ASIA scores compared with baseline, as well as progression in functional classification across ASIA grades A, B, C, and D.;To evaluate improvement in bladder function in patients with neurogenic bladder secondary to spinal cord injury undergoing the proposed treatments, using the Neurogenic Bladder Symptom Score (NBSS) questionnaire at baseline and at 3, 6, and 12 months after treatment. Reductions in total and domain-specific NBSS scores (incontinence, storage/voiding, and consequences) will be assessed, with a positive outcome defined as a decrease in total score compared with baseline, as well as improvement in urinary quality of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate pain reduction in patients with neurological sequelae secondary to spinal cord injury undergoing the proposed treatments, using the Visual Analog Scale (VAS) at baseline and at 3, 6, and 12 months after treatment. Reductions in pain scores over time will be assessed, with a positive outcome defined as a minimum decrease of 2 points on the VAS compared with baseline, as well as differences between treatment groups.;To evaluate improvement in functional capacity and reduction in disability in patients undergoing the proposed treatments, using the Oswestry Disability Index (ODI) questionnaire at baseline and at 3, 6, and 12 months after treatment. Reductions in questionnaire scores will be assessed, with a positive outcome defined as a minimum decrease of 15 to 20 points compared with baseline.;To evaluate reduction in muscle spasticity in patients with neurological sequelae secondary to spinal cord injury undergoing the proposed treatments, using the Modified Ashworth Scale at baseline and at 3, 6, and 12 months after treatment. Reductions in spasticity grade over time will be assessed, with a positive outcome defined as a minimum decrease of 1 point on the scale compared with baseline.;To evaluate improvement in quality of life in patients undergoing the proposed treatments, using the Short Form 36 (SF-36) questionnaire at baseline and at 3, 6, and 12 months after treatment. Increases in total and domain-specific SF-36 scores will be assessed, with a positive outcome defined as progressive improvement in scores compared with baseline.;To evaluate peripheral neurological function in patients undergoing the proposed treatments, using electroneuromyography at baseline and at 6 and 12 months after treatment. Changes in neurophysiological parameters, including nerve conduction velocity, muscle recruitment, and spontaneous activity, will be assessed by comparison with baseline values.;To evaluate the safety of the proposed interventions throughout the follow-up | — |
Countries
BR
Contacts
Public ContactJosé Fabio Lana
Orthoregen - Ensino e Pesquisa Em Medicina Regenerativa do Aparelho Locomotor LTDA
Outcome results
None listed