Status:
COMPLETED
Safety and Efficacy of Autologous Bone Marrow Stem Cells in Treating Spinal Cord Injury
Lead Sponsor:
International Stemcell Services Limited
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
20-55 years
Phase:
PHASE1
PHASE2
Brief Summary
The projected data related to the burden of spinal cord injuries induced limb paralysis in India is quite alarming. This is attributed to the rapid industrialization and economical development in the ...
Eligibility Criteria
Inclusion
- Must be able to give voluntary (patients may not be able to write) consent.
- Must be able to understand study information provided to him.
- Patients with complete spinal cord trans-section: at least post 6 months after spinal cord Injury (in chronic patients), \< 2 weeks in acute category and 2-8 weeks in subacute patients.
- The level of spinal cord injury must be between C4 and T12(neurological level)
- Spinal cord injury categorized in terms of ASIA Impairment scale.
- Age should be between 20-55 years
Exclusion
- Mechanical ventilation due to neurological impairment
- Multiple level trauma
- Undetermined size and location of Spinal Cord injury
- Gunshot or other penetrating trauma to the spinal cord
- Longitudinal dimension of injury by MRI is greater than 3spinal segments
- Associated severe head injury
- More than 9cms long bone fracture
- Women who are pregnant or lactating
- Serious pre-existing medical conditions
- Disease or impairment that precludes adequate neurological examination.
- Should not have co-morbidities like Diabetes, Systemic Hypertension etc.
- Severe co-morbidities/bed sores Tests positive for infectious diseases Deranged Coagulation profile and Hb \< 8mg/dl
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01186679
Start Date
January 1 2008
End Date
August 1 2010
Last Update
August 23 2010
Active Locations (1)
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1
Sita Bhateja Speciality Hospital
Bangalore, Karnataka, India, 560025