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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Bone marrow derived stem cells (BMSCs)
BMSCs 30-500 million plus conventional management
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
- Functional ability to perform activities of daily living on Modified Barthel Index Score [ Time Frame: 6 months ]
- Neurological deficit on NIHSS score [ Time Frame: 6 months and 1 year ]
- Measurement of disability on Modified Rankin Scale [ Time Frame: 3 months, 6 months and one year ]
- 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 ]
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
|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|
|Principal Investigator:||Kameshwar Prasad, MBBS, MD||All India Institute of Medical Sciences, New Delhi|