Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke

Stroke Clinical Trial

Official title:

Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02564328
• Other study ID #: 201400000003-2
• Status: Recruiting
• Phase: Phase 1
• First received: September 29, 2015
• Last updated: September 29, 2015
• Start date: November 2014
• Est. completion date: November 2017

Study information

• Verified date: September 2015
• Source: Southern Medical University, China
• Contact: Xiaodan Jiang, MD,PhD
• Phone: 86 20 61643268
• Email: jiangxiao_dan[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.Stem cell transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy and safy of the transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.

Description:

Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.It will brought heavy burden to patients themselves,their family and society.Drugs,rehabilitation excise and hyperbaric oxygen will improve functions after acute stroke.However,in the chronic ischemic stroke,there was few methods to improve the functions.In recently research,stem cell will be a new methods to improve the neural function after through differentiate to nervous cells and secrete some neurotrophic factors to repair the damage. In this study, the investigators will assess the safety and feasibility of intracerebral transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic ischemic stroke. The neurological outcome will be determined after transplantation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Aged 18-80 chronic ischemia stroke or patients

• With stroke history of more than 6 months, less than 60 months

• NIHSS (NIH stroke scale) score of 7 or more points

• Internal carotid artery territory infarction measured by MRI

• Can be hospitalized and signed informed consent

• With fewer effect by traditional post-stroke treatments or rehabilitations

Exclusion Criteria:

• Lacunar infarction

• Recurrent thrombotic diseases less than 6 months

• Hemorrhage stroke,brain tumor or MRI show the occlusion is not in the middle cerebral artery territory

• Pregnant women

• Can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition

• Penicillin anaphylaxis or some other drugs allergy

• Autoimmune disease

• Inaccessibility for follow up

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Genetic:
• Intravenous stem cell transplantation
Intravenous injection of autologous bone marrow mesenchymal stem cell transplantation

Locations

Country	Name	City	State
China	Xiaodan Jiang	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Southern Medical University, China	Second Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Fugl-Meyer Scale at 12 months		1,3,6 and 12 months	Yes
Secondary	Change from baseline in NIH Stroke Scale at 12 months		1,3,6 and 12 months	Yes
Secondary	Change from baseline in Barthel Index at 12 months		1,3,6 and 12 months	Yes
Secondary	Change from baseline in SSS at 12 months		1,3,6 and 12 months	Yes
Secondary	Change from baseline in mRS at 12 months		1,3,6 and 12 months	Yes
Secondary	Improvement of vision measured by brain visual examination		1,6 and 12 months	Yes