Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 169 for:    stem cell stroke

Stem Cell Therapy For Acute Ischemic Stroke Patients (InVeST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 7, 2015
First Posted Date  ICMJE April 24, 2015
Last Update Posted Date April 24, 2015
Study Start Date  ICMJE January 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2015)
Functional ability to perform activities of daily living on Modified Barthel Index Score [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cell Therapy For Acute Ischemic Stroke Patients
Official Title  ICMJE Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke: A Multi-Institutional Project
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Middle Cerebral Artery Infarction
  • Anterior Cerebral Artery Infarction
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Bone marrow derived stem cells (BMSCs)
    BMSCs 30-500 million plus conventional management
    Intervention: Other: BMSCs
  • No Intervention: Control
    Control: conventional management
Publications * Prasad K, Sharma A, Garg A, Mohanty S, Bhatnagar S, Johri S, Singh KK, Nair V, Sarkar RS, Gorthi SP, Hassan KM, Prabhakar S, Marwaha N, Khandelwal N, Misra UK, Kalita J, Nityanand S; InveST Study Group. Intravenous autologous bone marrow mononuclear stem cell therapy for ischemic stroke: a multicentric, randomized trial. Stroke. 2014 Dec;45(12):3618-24. doi: 10.1161/STROKEAHA.114.007028. Epub 2014 Nov 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2015)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02425670
Other Study ID Numbers  ICMJE BT/pr6815/MED/14/880/2005AIIMS
REFCTRI000046, 19.04.2008 ( Other Identifier: WHO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kameshwar Prasad, All India Institute of Medical Sciences, New Delhi
Study Sponsor  ICMJE All India Institute of Medical Sciences, New Delhi
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Kameshwar Prasad, MBBS, MD All India Institute of Medical Sciences, New Delhi
PRS Account All India Institute of Medical Sciences, New Delhi
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP