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

This study has been completed.
Sponsor:
Collaborator:
Department of Biotechnology-DBT India
Information provided by (Responsible Party):
Manipal Acunova Ltd.
ClinicalTrials.gov Identifier:
NCT01501773
First received: December 26, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Acute Stroke
Biological: Autologous bone marrow stem cell
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke

Further study details as provided by Manipal Acunova Ltd.:

Primary Outcome Measures:
  • Barthel index score [ Time Frame: six month post randomization ] [ Designated as safety issue: Yes ]
    The primary efficacy outcome is difference between the two groups in the modified Barthel index score at six month post randomization.


Secondary Outcome Measures:
  • NIHSS score and functional status [ Time Frame: 3, 6 and 12 months post randomization ] [ Designated as safety issue: Yes ]
    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


Enrollment: 120
Study Start Date: October 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: Control

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501773

Locations
India
All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Army Hospital (R & R Hospital)
New Delhi, Delhi, India
Post Graduate Institute of Medical Education and Research
Chandigarh, Haryana, India, 160012
Armed Forces Medical College
Pune, Maharastra, India, 411040
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, UttarPradesh, India, 226014
Sponsors and Collaborators
Manipal Acunova Ltd.
Department of Biotechnology-DBT 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
  More Information

No publications provided by Manipal Acunova Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Manipal Acunova Ltd.
ClinicalTrials.gov Identifier: NCT01501773     History of Changes
Other Study ID Numbers: INVEST
Study First Received: December 26, 2011
Last Updated: December 26, 2011
Health Authority: India: Indian Council of Medical Research

Keywords provided by Manipal Acunova Ltd.:
Acute ischemic stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on October 01, 2014