Acute Stroke Clinical Trial
Official title:
Phase II Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke
Verified date | December 2011 |
Source | Manipal Acunova Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Indian Council of Medical Research |
Study type | Interventional |
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 visualised as phase 2 study and will aim to determine dose response gradient of stem cell therapy and to explore if there is favorable risk to benefit ratio for autologous stem cell therapy in patient with acute ischamic stroke.
Status | Completed |
Enrollment | 120 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Sudden onset of focal neurologic deficit or impairment of consciousness. 2. CT or MRI scan of head showing no haematoma and relevant lesions within the MCA and ACA territory. 3. Age between 30 -70 years (after amendment 18 -70 years). 4. >7 to </=30 days passed since the onset of the qualifying event. 5. Glasgow Coma Scale score of >8 at the time of randomization, in aphasic Eye and Motor score of >6. 6. Modified Barthel Index score of 50 or less at the time of randomization. 7. NHISS score of 7 or more points and inability to walk unaided or raise upper limb by 90 degree. 8. 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 Criteria: - 1. Lacunar syndrome 2. Intubation 3. Posterior circulation stroke 4. Co morbidity likely to limit survival to less than 3 years eg. Hepatic or renal failure. 5. Inaccessibility for follow up. 6. Allergy to local anaesthetic. 7. Unwillingness to provide written informed consent. 8. Symptom of acute myocardial infarction or acute involvement of any other organ. 9. Pregnancy 10. HIV positive 11. Patient is a part of any other trial in last 6 months. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Post Graduate Institute of Medical Education and Research | Chandigarh | Haryana |
India | Sanjay Gandhi Postgraduate Institute of Medical Sciences | Lucknow | UttarPradesh |
India | All India Institute of Medical Sciences | New Delhi | Delhi |
India | Army Hospital (R & R Hospital) | New Delhi | Delhi |
India | Armed Forces Medical College | Pune | Maharastra |
Lead Sponsor | Collaborator |
---|---|
Manipal Acunova Ltd. | Ministry of Science and Technology, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Barthel index score | The primary efficacy outcome is difference between the two groups in the modified Barthel index score at six month post randomization. | six month post randomization | Yes |
Secondary | NIHSS score and functional status | NIHSS score at 6 months and one year post randomization. And degree of handicap as measured by Modified Ranking scale administered at 3, 6 and 12 months post randomization and functional status at 6 months and 12 months post randomization |
3, 6 and 12 months post randomization | Yes |
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