CTRI/2008/091/000046
Completed
Phase 2
Intravenous autologous bone marrow derived stem cells therapy for patients with acute ischemic stroke: A multi-institutional project.
Department of Biotechnology Ministry of Science and Technology Government of India New Delhi0 sites120 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Department of Biotechnology Ministry of Science and Technology Government of India New Delhi
- Enrollment
- 120
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Sudden onset of focal neurologic deficit or impairment of consciousness,
- •2\. Computerized tomographic or MRI scan of the head showing no haematoma, and relevant lesions within the MCA and ACA territory.
- •3\. Age between 18 and 70 years
- •4\. Seven days or more but less than 30 days has passed since the onset of the qualifying event,
- •5\. Glasgow Coma Scale score of above 8 at the time of randomization (Appendix 15\), in aphasic Eye and Motor score of more than 6,
- •6\. Modified Barthel index score of 50 or less at the time of randomization (Appendix 8\).
- •7\. NIHSS score of 7 or more points and inability to walk unaided or raise upper limb by 900 (Appendix 17\)
- •8\. Patient is stable: A patient will be defined as stable when he has normal respiration, is afebrile, has BP less than mean arterial pressure of 125mm Hg (but no hypotension defined as systolic BP \<90mmHg), has fasting venous blood sugar level less than 200mg% 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 three years e.g. malignant diseases, hepatic or renal failure
- •5\. Pre\-stroke disability leading to dependence on others for activities of daily living,
- •6\. Inaccessibility for follow\-up
- •7\. Allergy to local anaesthetic
- •8\. Unwillingness to provide written informed consent by self or assent by next of kin.
- •9\. Symptom of Acute myocardial infarction or acute involvement of any other organ.
- •10\. Pregnancy
Outcomes
Primary Outcomes
Not specified
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