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

NCT ID: NCT01297413

Last Updated: 2018-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2018-11-15

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stem cells

All subjects will receive allogeneic adult mesenchymal bone marrow stem cells

Group Type: EXPERIMENTAL

Allogeneic adult mesenchymal bone marrow stem cells

Intervention Type: BIOLOGICAL

Patients will receive intravenously one dose of 0.5-1.5 million cells per kg of allogeneic adult mesenchymal bone marrow stem cells

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

Mercy Gilbert Medical Center at AZ

UNKNOWN

Sponsor Role: collaborator

Chandler Regional Medical Center at Chandler AZ

UNKNOWN

Sponsor Role: collaborator

UCI Medical Center

UNKNOWN

Sponsor Role: collaborator

Stemedica Cell Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lev Verkh, PhD

Role: STUDY_DIRECTOR

Stemedica Cell Technologies, Inc.

Locations

Mercy Gilbert and Chandler Medical Center

Gilbert, Arizona, United States

University of California Irvine Department of Neurology

Orange, California, United States

University of California San Diego Division of Neurological Surgery

San Diego, California, United States

Countries

United States

References

Levy ML, Crawford JR, Dib N, Verkh L, Tankovich N, Cramer SC. Phase I/II Study of Safety and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Chronic Stroke. Stroke. 2019 Oct;50(10):2835-2841. doi: 10.1161/STROKEAHA.119.026318. Epub 2019 Sep 9.

Reference Type: DERIVED

PMID: 31495331 (View on PubMed)

Other Identifiers

STEM 101-M

Identifier Type: -

Identifier Source: org_study_id