Safety and efficacy of biological scaffolds in patients with spinal cord injury
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Improvement in the American Spinal Injury Association (ASIA) score, Functional independence measure (FIM) scores
Study Overview
Brief Summary
This study aims to evaluate the safety and efficacy of a biological scaffold in patients with acute spinal cord injury. It is a randomized comparative study involving surgical fixation with or without scaffold treatment. The scaffold is combined with exosomes and autologous bone marrow concentrate to support neural recovery. Participants will be monitored for neurological improvement and quality of life over a 2-year period using standard scoring systems. The research is a multi-institutional collaboration between IMS BHU and IIT Kanpur.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Acute spinal cord injury within 1 week having ASIA score A morbidity.
Exclusion Criteria
- •Previous spinal surgeries, associated multisystem injuries, inability to comply with follow-up, no associated comorbidities.
Outcomes
Primary Outcomes
Improvement in the American Spinal Injury Association (ASIA) score, Functional independence measure (FIM) scores
Time Frame: 3, 6, 12 months and then yearly for 2 years.
Secondary Outcomes
- Quality of life assessed by the EQ-5D scale, SCIM spinal cord independence measure, functional (10MWT, 6MWT, TUG, WISCI2)(1 month, 3 months, 6 months, 12 months, 2 years)
Investigators
Dr Sanjay Yadav
Institute of Medical Sciences, Banaras Hindu University