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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Stemedica Cell Technologies, Inc.
Sponsor:
Collaborators:
University of California, San Diego
Mercy Gilbert Medical Center at AZ
Chandler Regional Medical Center at Chandler AZ
Information provided by (Responsible Party):
Stemedica Cell Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01297413
First received: February 10, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Ischemic Stroke
Biological: Allogeneic adult mesenchymal bone marrow stem cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Stemedica Cell Technologies, Inc.:

Primary Outcome Measures:
  • The primary endpoint will be the safety of treatment with aMBMC during the twelve-month study period. [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • National Institutes of Health Stroke Scale Score. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The change from baseline in the Geriatric Depression Scale score at 1, 3, 6, 9, 12 months post-treatment, as available.


Estimated Enrollment: 35
Study Start Date: February 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stem cells
All subjects will receive allogeneic adult mesenchymal bone marrow stem cells
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01297413

Contacts
Contact: Sarah E Holland, RN, MSN, CCRC 858-966-8153
Contact: Ann Campbell, RN, BSN, CCRC 602-214-0886

Locations
United States, Arizona
Mercy Gilbert and Chandler Medical Center Recruiting
Gilbert, Arizona, United States, 85224
Contact: Nabil Dib, MD, MSc, FACC    602-214-0886      
Contact: Ann Campbell, RN, BSN, CCRC    602-214-0886      
Principal Investigator: Nabil Dib, MD, MSc, FACC         
United States, California
University of California San Diego Division of Neurological Surgery Recruiting
San Diego, California, United States, 92123
Contact: Michael L Levy, MD, PhD FACS    858-966-8574      
Contact: Sarah E Holland, RN, MSN, CCRC    858-966-8153      
Principal Investigator: Michael L Levy, MD, PhD FACS         
Sponsors and Collaborators
Stemedica Cell Technologies, Inc.
University of California, San Diego
Mercy Gilbert Medical Center at AZ
Chandler Regional Medical Center at Chandler AZ
Investigators
Study Director: Lev Verkh, PhD Stemedica Cell Technologies, Inc.
  More Information

No publications provided

Responsible Party: Stemedica Cell Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01297413     History of Changes
Other Study ID Numbers: STEM 101-M
Study First Received: February 10, 2011
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Stemedica Cell Technologies, Inc.:
allogeneic
adult
stem
cells
stroke
ischemic

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

ClinicalTrials.gov processed this record on October 23, 2014