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Stem Cell Therapy For Acute Ischemic Stroke Patients (InVeST)

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ClinicalTrials.gov Identifier: NCT02425670
Recruitment Status : Completed
First Posted : April 24, 2015
Last Update Posted : April 24, 2015
Sponsor:
Collaborators:
Ministry of Science and Technology, India
Army Hospital Research and Referral, New Delhi
Armed Forces Medical College, Pune
Postgraduate Institute of Medical Education and Research
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Information provided by (Responsible Party):
Kameshwar Prasad, All India Institute of Medical Sciences, New Delhi

Brief 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.


Condition or disease Intervention/treatment Phase
Middle Cerebral Artery Infarction Anterior Cerebral Artery Infarction Other: BMSCs Phase 2

Detailed Description:

Background: Stroke accounts for significant disability and there is need for novel treatment modality which can improve the functional outcome. In this randomized clinical trial, investigators proposed to examine stem cell therapy as a potential therapeutic modality. Stem cells in animal stroke models have shown reduction in infarct size and improvement in neurological function. Only one human clinical trial with intravenous autologous marrow stromal cell therapy of five patients has shown some benefit. The primary objective of this phase II study was to explore if there is favourable risk to benefit ratio for autologous bone marrow derived mononuclear stem cell therapy (BMSCs) in patients with acute ischemic stroke to justify a larger phase III trial.

Methods & Design: The study recruited 120 men and women aged 18-70 years presenting with acute ischemic stroke (7-29 days) and a NIHSS score of ≥ 7 and BI ≤ 50. Following baseline assessment (MRI Brain, Whole Body PET scan, EEG brain, CT scan Brain and clinical examination including National Institute of Health Stroke Scale (NIHSS), Barthel Index (BI), modified Rankin Scale (mRS), Glasgow Come Scale (GCS), participants were randomly allocated to two groups: conventional management alone (control group); or conventional management and autologous intravenous BMSCs transplantation (experimental group). Bone marrow was aspirated under local anaesthesia and the isolated BMSCs cells injected intravenously within 4 hours. The patients were monitored with hemogram & renal/liver function tests, CT scan brain at 36 hrs and clinical examination for a week. The patients were followed up to one year with periodic MRI brain at 3 months, 6 months, EEG & PET scan at 6 months and 1 year. The primary efficacy outcomes were difference between the two groups in the Modified Barthel index score and modified Rankin Scale score at six-month post-randomisation. The secondary efficacy outcomes are: NIHSS score at six-months and 1 year post-randomisation; and the modified Rankin scale score at 3 months and one year post-randomization, and functional status measured by barthel index (in binary scale <60 or >60 ) at six months and one year post-randomization. Dose response analysis were done by comparing outcomes in patients receiving various doses of bone marrow mononuclear cells.

Discussion: This phase 2 study was aimed to explore if there is a favourable risk-to-benefit ratio for stem cell therapy in patients with acute ischemic stroke. Investigators also planned to examine whether there is justification for phase III trial of autologous bone marrow derived mononuclear stem cell therapy for acute ischemic stroke.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke: A Multi-Institutional Project
Study Start Date : January 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: Bone marrow derived stem cells (BMSCs)
BMSCs 30-500 million plus conventional management
Other: BMSCs
30-500 million Autologous BMSCs will be given intravenously to patients with acute ischemic stroke (onset from 7 to less than 30 days).
Other Name: Stem cell arm

No Intervention: Control
Control: conventional management



Primary Outcome Measures :
  1. Functional ability to perform activities of daily living on Modified Barthel Index Score [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Neurological deficit on NIHSS score [ Time Frame: 6 months and 1 year ]
  2. Measurement of disability on Modified Rankin Scale [ Time Frame: 3 months, 6 months and one year ]
  3. Functional ability to perform activities of daily living on Modified Barthel Index (Functional status) on binary scale as independent (Barthel index > 60) or dead or dependent (Barthel Index <60) [ Time Frame: 6 months and one year ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients will be judged eligible if they have all of the following:

  1. Sudden onset of focal neurologic deficit or impairment of consciousness,
  2. 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.
  3. Age between 18 and 75 years
  4. Seven days or more but less than 30 days since the onset of the qualifying event,
  5. Glasgow Coma Scale score of above 8 at the time of randomization, in aphasic Eye and Motor score of more than 6,
  6. Modified Barthel index score of 50 or less at the time of randomization.
  7. NIHSS score of 7 or more points and inability to walk unaided or raise upper limb by 90 °
  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:

Patients meeting the inclusion criteria will be considered ineligible for the study if they have any one of the following:

  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. Human immunodeficiency virus (HIV)/hepatitis C virus (HCV)/HbsAg positive.
  12. Patient is a part of any other trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425670


Locations
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India
Army Hospital (Referral and Research Centre),
Delhi Cantonment, Delhi, India, 110010
All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Armed Forces Medical College
Pune, Maharashtra, India, 411040
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India, 226014
Postgraduate Institute of Medical Education & Research
Chandigarh, India, 160 012
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Ministry of Science and Technology, India
Army Hospital Research and Referral, New Delhi
Armed Forces Medical College, Pune
Postgraduate Institute of Medical Education and Research
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Investigators
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Principal Investigator: Kameshwar Prasad, MBBS, MD All India Institute of Medical Sciences, New Delhi

Additional Information:
Publications of Results:
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Responsible Party: Kameshwar Prasad, Professor and Head, Department of Neurology, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT02425670     History of Changes
Other Study ID Numbers: BT/pr6815/MED/14/880/2005AIIMS
REFCTRI000046, 19.04.2008 ( Other Identifier: WHO )
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015
Keywords provided by Kameshwar Prasad, All India Institute of Medical Sciences, New Delhi:
Brain attack
stroke
Ischemic stroke
stem cell therapy
Additional relevant MeSH terms:
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Stroke
Infarction, Middle Cerebral Artery
Infarction, Anterior Cerebral Artery
Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebral Arterial Diseases
Intracranial Arterial Diseases