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

December 26, 2011 updated by: Manipal Acunova Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

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
    • Delhi
      • New Delhi, Delhi, India, 110029
        • All India Institute of Medical Sciences
      • New Delhi, Delhi, India
        • Army Hospital (R & R Hospital)
    • Haryana
      • Chandigarh, Haryana, India, 160012
        • Post Graduate Institute of Medical education and Research
    • Maharastra
      • Pune, Maharastra, India, 411040
        • Armed Forces Medical College
    • UttarPradesh
      • Lucknow, UttarPradesh, 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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Sudden onset of focal neurologic deficit or impairment of consciousness.
  2. CT or MRI scan of head showing no haematoma and relevant lesions within the MCA and ACA territory.
  3. Age between 30 -70 years (after amendment 18 -70 years).
  4. >7 to </=30 days passed since the onset of the qualifying event.
  5. Glasgow Coma Scale score of >8 at the time of randomization, in aphasic Eye and Motor score of >6.
  6. Modified Barthel Index score of 50 or less at the time of randomization.
  7. NHISS score of 7 or more points and inability to walk unaided or raise upper limb by 90 degree.
  8. 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: -

  1. Lacunar syndrome
  2. Intubation
  3. Posterior circulation stroke
  4. Co morbidity likely to limit survival to less than 3 years eg. Hepatic or renal failure.
  5. Inaccessibility for follow up.
  6. Allergy to local anaesthetic.
  7. Unwillingness to provide written informed consent.
  8. Symptom of acute myocardial infarction or acute involvement of any other organ.
  9. Pregnancy 10. HIV positive 11. Patient is a part of any other trial in last 6 months.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Autologous bone marrow stem cell
Biological: Autologous bone marrow stem cell
Autologous bone marrow stem cell have bone marrow aspiration and receive 30-500 million bone marrow mononuclear cells intravenously on the day of randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel index score
Time Frame: six month post randomization
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
Time Frame: 3, 6 and 12 months post randomization
  1. NIHSS score at 6 months and one year post randomization.
  2. 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

Collaborators and Investigators

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

Sponsor

Manipal Acunova Ltd.

Collaborators

Ministry of Science and Technology, India

Investigators

  • Principal Investigator: Dr. Kameshwar Prasad, MBBS, MD, All India Institute of Medical Sciences, New Delhi
  • Principal Investigator: Dr. Usha Kant Misra, MBBS, MD, DM, Sanjay Gandhi Postgraduate Institute of Medical Sciences
  • Principal Investigator: Dr. R.S Sarkar, Armed Forces Medical College
  • Principal Investigator: Dr. Sudesh Kumar Prabhakar, MBBS, MD, DM, Post Graduate Institute of Medical education and Research
  • Principal Investigator: Dr. Sharat Joshi, MBBS,MD, DM, Army R & R Hospital

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

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

October 1, 2008

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

December 26, 2011

First Submitted That Met QC Criteria

December 26, 2011

First Posted (ESTIMATE)

December 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 29, 2011

Last Update Submitted That Met QC Criteria

December 26, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INVEST

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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