Stem Cell Therapy For Acute Ischemic Stroke Patients (InVeST)

April 21, 2015 updated by: Kameshwar Prasad, All India Institute of Medical Sciences, New Delhi

Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke: A Multi-Institutional Project

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160 012
        • Postgraduate Institute of Medical Education & Research
    • Delhi
      • Delhi Cantonment, Delhi, India, 110010
        • Army Hospital (Referral and Research Centre),
      • New Delhi, Delhi, India, 110029
        • All India Institute of Medical Sciences
    • Maharashtra
      • Pune, Maharashtra, India, 411040
        • Armed Forces Medical College
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226014
        • Sanjay Gandhi Postgraduate Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • Stem cell arm
No Intervention: Control
Control: conventional management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional ability to perform activities of daily living on Modified Barthel Index Score
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Neurological deficit on NIHSS score
Time Frame: 6 months and 1 year
6 months and 1 year
Measurement of disability on Modified Rankin Scale
Time Frame: 3 months, 6 months and one year
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
6 months and one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Collaborators

Postgraduate Institute of Medical Education and Research
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Ministry of Science and Technology, India
Army Hospital Research and Referral, New Delhi
Armed Forces Medical College, Pune

Investigators

  • Principal Investigator: Kameshwar Prasad, MBBS, MD, All India Institute of Medical Sciences, New Delhi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 24, 2015

Study Record Updates

Last Update Posted (Estimate)

April 24, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BT/pr6815/MED/14/880/2005AIIMS
  • REFCTRI000046, 19.04.2008 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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