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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functional ability to perform activities of daily living on Modified Barthel Index Score
. 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
. Lacunar syndrome
. Intubation
. Posterior Circulation Stroke
. Co-morbidity likely to limit survival to less than three years e.g. malignant diseases, hepatic or renal failure
. Pre-stroke disability leading to dependence on others for activities of daily living,
. Inaccessibility for follow-up
. Allergy to local anaesthetic
. Unwillingness to provide written informed consent by self or assent by next of kin.