Status:
COMPLETED
Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke
Lead Sponsor:
Manipal Acunova Ltd.
Collaborating Sponsors:
Ministry of Science and Technology, India
Conditions:
Acute Stroke
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
A multi-centric initiative to study safety,feasibility and efficacy of using intravenous autologous bone marrow mononuclear cells(BMMC) in patients with acute ischemic stroke.This phase of study is vi...
Detailed Description
This phase of the study will have two arms developed through random allocation: one arm for intravenous autologous bone marrow derived stem cell/mononuclear cells(BMMC arm); and second control arm. Pa...
Eligibility Criteria
Inclusion
- Sudden onset of focal neurologic deficit or impairment of consciousness.
- CT or MRI scan of head showing no haematoma and relevant lesions within the MCA and ACA territory.
- Age between 30 -70 years (after amendment 18 -70 years).
- \>7 to \</=30 days passed since the onset of the qualifying event.
- Glasgow Coma Scale score of \>8 at the time of randomization, in aphasic Eye and Motor score of \>6.
- Modified Barthel Index score of 50 or less at the time of randomization.
- NHISS score of 7 or more points and inability to walk unaided or raise upper limb by 90 degree.
- Patient is stable. ( normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar \< 200 mg% and normal urea/electrolytes for at least 48 hours.)
Exclusion
- Lacunar syndrome
- Intubation
- Posterior circulation stroke
- Co morbidity likely to limit survival to less than 3 years eg. Hepatic or renal failure.
- Inaccessibility for follow up.
- Allergy to local anaesthetic.
- Unwillingness to provide written informed consent.
- Symptom of acute myocardial infarction or acute involvement of any other organ.
- Pregnancy 10. HIV positive 11. Patient is a part of any other trial in last 6 months.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01501773
Start Date
October 1 2008
End Date
October 1 2011
Last Update
December 29 2011
Active Locations (5)
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1
Post Graduate Institute of Medical Education and Research
Chandīgarh, Haryana, India, 160012
2
Armed Forces Medical College
Pune, Maharashtra, India, 411040
3
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029
4
Army Hospital (R & R Hospital)
New Delhi, National Capital Territory of Delhi, India