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To study safety and efficacy of biomaterials in helping recovery of participants after spinal cord injury who are not able to walk

Safety and efficacy of biological scaffolds in patients with spinal cord injury - NIL

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091977
Enrollment
12
Registered
2025-07-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G952- Other and unspecified cord compression

Interventions

Intervention1: biodegradable scaffold, exosomes, autologous bone marrow concentrate: Biodegradable scaffold implanted at the injury site, Exosomes isolated from human adipose mesenchymal stem cells (1

Sponsors

Dr Sanjay Yadav
Lead Sponsor
Institute of Medical Sciences Banaras Hindu University
Collaborator
Prof Ashok Kumar
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Acute spinal cord injury within 1 week having ASIA score A morbidity

Exclusion criteria

Exclusion criteria: Previous spinal surgeries, associated multisystem injuries, inability to comply with follow-up, no associated comorbidities

Design outcomes

Primary

MeasureTime frame
Improvement in the American Spinal Injury Association (ASIA) score, Functional independence measure (FIM) scoresTimepoint: 3, 6, 12 months and then yearly for 2 years.

Secondary

MeasureTime frame
Quality of life assessed by the EQ-5D scale, SCIM spinal cord independence measure, functional (10MWT, 6MWT, TUG, WISCI2)Timepoint: 1 month, 3 months, 6 months, 12 months, 2 years

Countries

India

Contacts

Public ContactProf Chooramani Gopal

Indian Institute of Technology Kanpur

ashokkum@iitk.ac.in9936491834

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026