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A Study of Allogeneic Mesenchymal Bone Marrow Cells in Subjects With Ischemic Stroke

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: NCT01297413
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : December 3, 2018
Sponsor:
Collaborators:
University of California, San Diego
Mercy Gilbert Medical Center at AZ
Chandler Regional Medical Center at Chandler AZ
UCI Medical Center
Information provided by (Responsible Party):
Stemedica Cell Technologies, Inc.

Tracking Information
First Submitted Date  ICMJE February 10, 2011
First Posted Date  ICMJE February 16, 2011
Last Update Posted Date December 3, 2018
Study Start Date  ICMJE February 2011
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2011)
The primary endpoint will be the safety of treatment with aMBMC during the twelve-month study period. [ Time Frame: 12 month ]
The primary endpoint will be the safety of treatment with aMBMC during the twelve-month study period as determined by the incidence and severity of adverse events, clinically-significant changes on clinical laboratory tests, vital signs, physical and neurologic examinations.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01297413 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2011)
  • National Institutes of Health Stroke Scale Score. [ Time Frame: 12 months ]
    The change from the baseline in National Institutes of Health Stroke Scale score will be calculated at 1, 3, 6, 9, 12 months post-treatment, as available:
  • Mini Mental Status Exam score. [ Time Frame: 12 month ]
    The change from the baseline in Mini Mental Status Exam score will be calculated at 1, 3, 6, 9, 12 months post-treatment, as available.
  • Barthel Index Score. [ Time Frame: 12 month ]
    The change from the baseline in Barthel Index score at 1, 3, 6, 9, 12 months post-treatment, as available.
  • The Geriatric Depression Scale Score. [ Time Frame: 12 month ]
    The change from baseline in the Geriatric Depression Scale score at 1, 3, 6, 9, 12 months post-treatment, as available.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2011)
  • National Institutes of Health Stroke Scale. [ Time Frame: 12 months ]
    The change from the baseline in National Institutes of Health Stroke Scale score will be calculated at 1, 3, 6, 9, 12 months post-treatment, as available:
  • Mini Mental Status Exam score. [ Time Frame: 12 month ]
    The change from the baseline in Mini Mental Status Exam score will be calculated at 1, 3, 6, 9, 12 months post-treatment, as available.
  • Barthel Index. [ Time Frame: 12 month ]
    The change from the baseline in Barthel Index score at 1, 3, 6, 9, 12 months post-treatment, as available.
  • The Geriatric Depression Scale [ Time Frame: 12 month ]
    The change from baseline in the Geriatric Depression Scale score at 1, 3, 6, 9, 12 months post-treatment, as available.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Allogeneic Mesenchymal Bone Marrow Cells in Subjects With Ischemic Stroke
Official Title  ICMJE A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Ischemic Stroke
Brief Summary The purpose of this study is to assess the safety and tolerability of allogeneic adult mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke.
Detailed Description

Stroke remains a major global healthcare problem. Recent data compiled by the American Heart Association (AHA) for 2008 show that the annual incidence of new or recurrent stroke in the United States is about 780,000, with approximately 600,000 of these strokes being first attacks. Among adults age 20 and older, the estimated prevalence of stroke in 2005 was 5.8 million in the United States, resulting in >150,000 deaths annually, with 4.8 million stroke survivors alive today. Stroke ranks as the country's third leading cause of death, behind only cancer and heart disease. The only approved treatments of acute ischemic stroke involve restoring blood flow to the affected region by using thrombolytics or mechanical devices that physically remove clots. However, the use of thrombolytics is limited due to the therapeutic window of < 3-6 hours post onset of stroke symptoms such that only a small fraction of stroke patients receive this therapy. Following the completion of a stroke, there is little therapy to offer patients to promote recovery other than physical, occupational, and speech therapy.

Allogeneic mesenchymal stem cells have been used in a number of clinical trials for different indications demonstrated the safety of allogeneic mesenchymal stem cell treatment. In addition to their ability to differentiate into multiple different cell types that would be contributory to the recovery and repair of the brain by replacing destroyed cells, mesenchymal stem cells also secrete angiogenins, cytokines and trophic factors that can support and stimulate multiple other cell types. The cascade of cellular events following the release of these cytokines and trophic factors would also potentially lead to beneficial effects by restoring blood supply, by rescuing cells at risk, and by stimulating the remaining cell populations to repair and propagate new cells and synaptic connections.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Stroke
Intervention  ICMJE Biological: Allogeneic adult mesenchymal bone marrow stem cells
Patients will receive intravenously one dose of 0.5-1.5 million cells per kg of allogeneic adult mesenchymal bone marrow stem cells
Study Arms  ICMJE Experimental: Stem cells
All subjects will receive allogeneic adult mesenchymal bone marrow stem cells
Intervention: Biological: Allogeneic adult mesenchymal bone marrow stem cells
Publications * Not Provided

*   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: December 21, 2015)
38
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2011)
35
Actual Study Completion Date  ICMJE November 15, 2018
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of ischemic stroke for longer than 6 months
  • Brain CT/MRI scan at initial diagnosis and at enrollment consistent with ischemic stroke
  • No substantial improvement in neurologic or functional deficits for the 2 months prior to enrollment
  • NIHSS score between 6-20
  • Life expectancy greater than 12 months
  • Prior to treatment patient received standard medical care for the secondary prevention of ischemic stroke
  • Adequate organ function as defined by the following criteria:

Exclusion Criteria:

  • History of uncontrolled seizure disorder
  • History of cancer within the past 5 years.
  • History of cerebral neoplasm
  • Positive for hepatitis B, C or HIV
  • Myocardial infarction withing six months of study entry
  • Findings on baseline CT suggestive of subarachnoid or intracerebral hemorrhage within past 12 months.
  • Allergies to Bovine or Porcine products
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01297413
Other Study ID Numbers  ICMJE STEM 101-M
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stemedica Cell Technologies, Inc.
Study Sponsor  ICMJE Stemedica Cell Technologies, Inc.
Collaborators  ICMJE
  • University of California, San Diego
  • Mercy Gilbert Medical Center at AZ
  • Chandler Regional Medical Center at Chandler AZ
  • UCI Medical Center
Investigators  ICMJE
Study Director: Lev Verkh, PhD Stemedica Cell Technologies, Inc.
PRS Account Stemedica Cell Technologies, Inc.
Verification Date November 2018

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