Safety of Autologous M2 Macrophage in Treatment of Non-Acute Stroke Patients

Ischemic Stroke Clinical Trial

Official title:

Safety and Feasibility of Autologous M2 Macrophage Transplantation in Treatment of Non-Acute Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845350
• Other study ID #: STR-M2-2013
• Status: Completed
• Phase: Phase 1
• First received: April 24, 2013
• Last updated: November 3, 2016
• Start date: October 2012
• Est. completion date: October 2015

Study information

• Verified date: November 2016
• Source: Siberian Branch of the Russian Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether M2 macrophages are safe and feasible in the treatment of non-acute stroke patients

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 macrophage transplantation is associated with improved neurological outcome after non-acute stroke

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke

Intervention

Other:
• M2 macrophage introduction
Generation of autologous M2 macrophages from peripheral blood of non-acute stroke patients Intrathecal introduction of autologous M2 macrophages

Locations

Country	Name	City	State
Russian Federation	Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Siberian Branch of the Russian Academy of Medical Sciences

Country where clinical trial is conducted

Russian Federation, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with recurrent vascular episodes		1-3 days, 6 months	Yes
Primary	The number of patients with severe adverse events	Occurence of severe adverse events including mortality, neurological worsening and seizures	1-3 days, 6 months	Yes
Secondary	Improvement of functional outcome in National Institutes of Health Stroke Scale (NIHSS)		1-3 days, 6 months	No
Secondary	Improvement in Barthel Index		1-3 days, 6 months	No
Secondary	Improvement in modified Rankin scale		1-3 days, 6 months	No