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

November 29, 2018 updated by: Stemedica Cell Technologies, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2
  • Phase 1

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

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85224
        • Mercy Gilbert and Chandler Medical Center
    • California
      • Orange, California, United States, 92868
        • University of California Irvine Department of Neurology
      • San Diego, California, United States, 92123
        • University of California San Diego Division of Neurological Surgery

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:
12 months
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.
12 month
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.
12 month
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.
12 month

Collaborators and Investigators

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

Sponsor

Stemedica Cell Technologies, Inc.

Collaborators

University of California, San Diego
Mercy Gilbert Medical Center at AZ
Chandler Regional Medical Center at Chandler AZ
UCI Medical Center

Investigators

  • Study Director: Lev Verkh, PhD, Stemedica Cell Technologies, Inc.

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

February 1, 2011

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

November 15, 2018

Study Registration Dates

First Submitted

February 10, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (Estimate)

February 16, 2011

Study Record Updates

Last Update Posted (Actual)

December 3, 2018

Last Update Submitted That Met QC Criteria

November 29, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEM 101-M

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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