Status:
COMPLETED
Safety of Autologous M2 Macrophage in Treatment of Non-Acute Stroke Patients
Lead Sponsor:
Siberian Branch of the Russian Academy of Medical Sciences
Conditions:
Ischemic Stroke
Hemorrhagic Stroke
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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
Detailed Description
Our primary hypothesis is that autologous M2 macrophage transplantation via intrathecal introduction is feasible and safe after non-acute stroke. Our secondary hypothesis is that autologous M2 macroph...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01845350
Start Date
October 1 2012
End Date
October 1 2015
Last Update
November 4 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)
Novosibirsk, Russia, 630099