CompletedPhase 2

Stem Cell Therapy For Acute Ischemic Stroke Patients

India120 participantsStarted 2009-01

Plain-language summary

The purpose of this study is to determine whether patients with subacute ischemic stroke will benefit from infusion of patient's own bone marrow derived stem cells. Primary Hypothesis: Intravenous injection of bone marrow mononuclear cells at a dose of 30 to 500 million in patients with subacute ischemic stroke results in reduction of infarct volume and improvement of neurological function compared to those without the injection. Secondary Hypothesis: Patients receiving more than 100 million Bone marrow derived stem cells (BMSC) will have better outcome than those receiving fewer dosages of cells.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Sudden onset of focal neurologic deficit or impairment of consciousness,
✓. Computerized tomographic or MRI scan of the head showing no primary haematoma, and relevant lesions within the Middle Cerebral Artery (MCA) and anterior cerebral artery (ACA) territory. Hemorrhagic changes in infarct are acceptable.
✓. Age between 18 and 75 years
✓. Seven days or more but less than 30 days since the onset of the qualifying event,
✓. Glasgow Coma Scale score of above 8 at the time of randomization, in aphasic Eye and Motor score of more than 6,
✓. Modified Barthel index score of 50 or less at the time of randomization.
✓. NIHSS score of 7 or more points and inability to walk unaided or raise upper limb by 90 °
✓. 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

What they're measuring

Functional ability to perform activities of daily living on Modified Barthel Index Score

Timeframe: 6 months

Trial details

NCT IDNCT02425670

SponsorAll India Institute of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-10

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