Stem cells therapy for patients with acute ischemic stroke.

Phase 2

Completed

Registration Number: CTRI/2008/091/000046

Lead Sponsor: Department of Biotechnology Ministry of Science and Technology Government of India New Delhi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

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

11. HIV positive.

12. Patient is a part of any other trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference between the two groups in the Modified Barthel index scoreTimepoint: At 180 (-7 to + 28 days) days post-randomisation

Secondary Outcome Measures

Name	Time	Method
Functional statusTimepoint: At 180 (-7 to +28 Days) Days and 365 (-7 to +28 Days) Days post-randomization;Modified Rankin scaleTimepoint: At 180 (-7 to + 28 Days) Days and 365 (-7 to +28 Days) Days post-randomisation;NIHSS scoreTimepoint: At 180 (-7 to + 28 Days) Days and 365 (-7 to +28 Days) Days post-randomisation