Safety of Autologous M2 Macrophage in Treatment of Non-Acute Stroke Patients
Safety and Feasibility of Autologous M2 Macrophage Transplantation in Treatment of Non-Acute Stroke Patients
1 other identifier
interventional
13
1 country
1
Brief Summary
The purpose of this study is to determine whether M2 macrophages are safe and feasible in the treatment of non-acute stroke patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 24, 2013
CompletedFirst Posted
Study publicly available on registry
May 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedNovember 4, 2016
November 1, 2016
1.5 years
April 24, 2013
November 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
The number of patients with severe adverse events
Occurence of severe adverse events including mortality, neurological worsening and seizures
1-3 days, 6 months
Secondary Outcomes (3)
Improvement of functional outcome in National Institutes of Health Stroke Scale (NIHSS)
1-3 days, 6 months
Improvement in Barthel Index
1-3 days, 6 months
Improvement in modified Rankin scale
1-3 days, 6 months
Other Outcomes (1)
Number of patients with recurrent vascular episodes
1-3 days, 6 months
Study Arms (1)
M2 macrophages
OTHERM2 macrophage introduction
Interventions
* Generation of autologous M2 macrophages from peripheral blood of non-acute stroke patients * Intrathecal introduction of autologous M2 macrophages
Eligibility Criteria
You may qualify if:
- Computed tomography confirmed ischemic or hemorrhagic stroke
- Duration since stroke onset more than 3 and less than 12 months
- Age between 18 and 75 years old
- Persistent neurological deficits more than 4 points in NIHSS stroke scale
- Signed informed consent
You may not qualify if:
- The history of previous stroke
- Seizures
- Thrombophilias or primary hematological diseases
- Malignancy
- Hepatic or renal dysfunctions
- Hemodynamic or respiratory instability
- Autoimmune disease
- HIV or uncontrolled bacterial, fungal, or viral infections
- Pregnancy
- Participation in other clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)
Novosibirsk, 630099, Russia
Related Publications (1)
Chernykh ER, Shevela EY, Starostina NM, Morozov SA, Davydova MN, Menyaeva EV, Ostanin AA. Safety and Therapeutic Potential of M2 Macrophages in Stroke Treatment. Cell Transplant. 2016;25(8):1461-71. doi: 10.3727/096368915X690279. Epub 2015 Dec 14.
PMID: 26671426RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Elena R. Chernykh, MD, PhD
Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Researcher, Laboratory of Cellular Therapy, Research Institute of Clinical Immunology
Study Record Dates
First Submitted
April 24, 2013
First Posted
May 3, 2013
Study Start
October 1, 2012
Primary Completion
April 1, 2014
Study Completion
October 1, 2015
Last Updated
November 4, 2016
Record last verified: 2016-11