Status:
COMPLETED
Autologous Bone Marrow Cell Transplantation in Persons With Acute Spinal Cord Injury- An Indian Pilot Study.
Lead Sponsor:
Indian Spinal Injuries Centre
Collaborating Sponsors:
Indian Council of Medical Research
Conditions:
Acute Spinal Cord Injury
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
Pilot study on 7 subjects in each group (total 21 subjects) to establish the safety and feasibility of autologous bone marrow cell transplantation in case of acute complete spinal cord injury by each ...
Detailed Description
Intervention : Autologous bone marrow cell: Transplantation of the autologous bone marrow cell transplantation through one of the below mentioned techniques: 1. Directly into the injured spinal cord s...
Eligibility Criteria
Inclusion
- Acute spinal cord injury between 10 days and 14 days post injury.
- The subject must have a traumatic spinal cord injury between the spinal segmental levels T1 and T12 (Neurological Level).
- Must have a complete injury (ASIA-A).
Exclusion
- Subject whose medical condition requires mechanical ventilation.
- Subjects with neurological level of injury above T1 and below T12.
- Subjects more than 14 days and less than 10 days post-injury.
- Lower motor neuron injury.
- Subjects with pathological fracture.
- Spinal Injuries in subjects with Ankylosing Spondylitis.
- Subjects with extremes of age: less than 18 years or more than 50 years.
- Subjects with pre-existing severe medical disease which would affect the outcome like severe diabetes, rheumatoid arthritis.
- Subjects with Psychological disorders.
- Female subjects with pregnancy.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT02260713
Start Date
February 1 2011
End Date
November 1 2017
Last Update
March 12 2018
Active Locations (1)
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1
Indian Spinal Injury Center
New Delhi, National Capital Territory of Delhi, India, 110070