Status:
UNKNOWN
Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Spinal Cord Injury
Lead Sponsor:
Chaitanya Hospital, Pune
Conditions:
Spinal Cord Injury.
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
This Study is a single arm,Phase I/II , single centre trial to check active comparing the safety and efficacy of Bone marrow derived autologous cell(100 million per dose) trial to be conducted for 36 ...
Detailed Description
A spinal cord injury (SCI) refers to any injury to the spinal cord that is caused by trauma instead of disease.\[1\] Depending on where the spinal cord and nerve roots are damaged, the symptoms can va...
Eligibility Criteria
Inclusion
- Patient should suffer from Spinal cord injury.
- willingness to undergo bone marrow derived autologous cell therapy.
- patient those provide fully Informed consent form for the study.
- Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
- traumatic Injury of spinal cord with complete or partial damage by MRI and Spinal cord injury level should be below C4
Exclusion
- Patient with pre- existing or current systemic disease such as Lung, liver,(exception:history of uncomplicated hepatitis A)gastrointestinal,cardiac , immunodeficiency(HIV)
- History of life threatening allergic or immune - mediated reaction.
- haemodynamically unstable patients.
- patient suffer from peripheral muscular dystrophy.
- lactating and pregnant woman
- alcohol drug abuse /dependence
- positive test result for hepatitis A and Hepatitis B OR C
- Major-traumatic brain injury and patient with psychiatric illness .
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01833975
Start Date
September 1 2014
End Date
September 1 2016
Last Update
September 17 2014
Active Locations (1)
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1
Chaitanya Hospital
Pune, Maharashtra, India, 411009