Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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This phase of the study will have two arms developed through random allocation: one arm for intravenous autologous bone marrow derived stem cell/mononuclear cells(BMMC arm); and second control arm. Patients with acute ischaemic stroke between 7-30 days after onset with moderae severity in sable condition will be entered into the study after informed consent. Both arms will receive standard treatment but BMMC arm will,in addition,have bone marrow aspiration and receive autologous 30-500 million bone marrow mononuclear cells intravenously on the day of randomisation and all patients will be followed at DaY 7 ± days, Day 90(-7 days to +14 days), Day 180(-7 days to +28 days)and Day 365 (-7 days to + 28 days). A number of safety and efficacy variables will be measured. This phase 2 study will aim to determine dose response gradient of stem cell therapy and to explore if results have a favourable risk to benefit ratio to justify a phase 3 study. This will be the first human trial to determine and compare favourable and unfavourable effects of bone marrow mononuclear cells(mainly CD34) in acute ischamic stroke and also the first multi-centric study with potential to achieve a reasonable sample size in a relatively short time.

Official Title
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Phase II Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke

Conditions
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Acute Stroke

Intervention / Treatment
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* Biological: Autologous bone marrow stem cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sudden onset of focal neurologic deficit or impairment of consciousness. CT or MRI scan of head showing no haematoma and relevant lesions within the MCA and ACA territory. Age between 30 -70 years (after amendment 18 -70 years). >7 to </=30 days passed since the onset of the qualifying event. Glasgow Coma Scale score of >8 at the time of randomization, in aphasic Eye and Motor score of >6. Modified Barthel Index score of 50 or less at the time of randomization. NHISS score of 7 or more points and inability to walk unaided or raise upper limb by 90 degree. 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: - Lacunar syndrome Intubation Posterior circulation stroke Co morbidity likely to limit survival to less than 3 years eg. Hepatic or renal failure. Inaccessibility for follow up. Allergy to local anaesthetic. Unwillingness to provide written informed consent. Symptom of acute myocardial infarction or acute involvement of any other organ. Pregnancy 10. HIV positive 11. Patient is a part of any other trial in last 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous bone marrow stem cell<br> | Biological: Autologous bone marrow stem cell<br>* Autologous bone marrow stem cell have bone marrow aspiration and receive 30-500 million bone marrow mononuclear cells intravenously on the day of randomization.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute ischemic stroke