Spinal Cord Injuries
Conditions
Interventions
This was an open label, single-arm clinical trial (although its original design was of a randomized, controlled, single-blind, two-arm study). Experimental group: 10 individuals diagnosed with complet
D12.776.395
Sponsors
Secretaria Municipal de Saúde do Rio de Janeiro
Universidade Federal do Rio de Janeiro
Comissão Nacional de Ética em Pesquisa
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Individuals of both sexes aged 18 to 60 years; patients bearing acute spinal cord injury up to 72 hours classified as complete (AIS A); location of the lesion between C4 and T12; indication for spinal decompression or fixation surgery
Exclusion criteria
Exclusion criteria: Presence of severe traumatic brain injury; lack of indication for spinal surgery; need for permanent mechanical respiratory support; polytrauma; prior diagnosis of neurological diseases such as Alzheimer’s disease, Amyotrophic Lateral Sclerosis, or sequelae of Stroke; alcohol and/or drug abuse or dependence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: Treatment with polylaminin in patients with complete spinal cord injury in the acute phase is expected not to cause medical complications beyond those anticipated for this condition, nor to result in clinical/neurological deterioration. This will be verified through clinical and neurological examinations and comparison with data reported in the medical literature for patients not treated with any drug. ;Observed Outcome 1: The medical complications observed were qualitatively similar to those previously reported in the medical literature, with 100% of participants experiencing at least one complication during hospitalization, compared to 84% reported in the literature. The fact that the sample in the present study was defined as a convenience sample prevents quantitative analyses from being conducted. No cases of neurological deterioration were observed during the 1-year follow-up period. ;Expected Outcome 2: The treatment with polylaminin is expected not to cause alterations in hematological or biochemical parameters indicative of liver and kidney toxicity. This will be verified through blood tests conducted before and at 2 and 10 days after the intervention, based on the absence of moderate elevations (more than 2.5 times) compared to reference values. ;Observed Outcome 2: Only mild deviations (up to 2.5 times the reference values) in hematological and biochemical parameters were found. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Outcome 3: The treatment with polylaminin is expected to promote the conversion of the ASIA Injury Scale (AIS) grade from A to C or D, meaning recovery of motor control verified through neurological AIS examination within the 1-year period of the follow-up.;Observed outcome 3: Among the 8 patients treated with polylaminin, 6 (75%) showed conversion of the AIS grade to C (5) or D (1), suggesting a higher conversion rate than reported in the literature for untreated patients (up to 15%). | — |
Countries
Brazil
Contacts
Public ContactTatiana Coelho-Sampaio
Universidade Federal do Rio de Janeiro
Outcome results
None listed