Autologous Endothelial Progenitor Cells Transplantation for Chronic Ischemic Stroke

Phase 1

Completed

• Conditions: Stroke
• Interventions: Drug: Intravenous stem cell transplantation

• Registration Number: NCT02605707
• Lead Sponsor: Southern Medical University, China

Brief 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 endothelial progenitor cells in patients with chronic stroke.

Detailed 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 endothelial progenitor cells in patients with chronic ischemic stroke. The neurological outcome will be determined after transplantation.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-11-12
• Study First Submitted QC: 2015-11-12
• Study First Posted: 2015-11-16
• Primary Completion: 2017-12
• Study Completion: 2020-02
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-01
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous stem cell transplantation	Intravenous stem cell transplantation	Intravenous transplantation of autologous endothelial progenitor cells plus conventional treatment include rehabilitation

Primary Outcome Measures

Name	Time	Method
Change from baseline in Fugl-Meyer Scale at 24 months	1,3,6,12 and 24months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in SSS at 24 months	1,3,6,12 and 24months
Change from baseline in NIH Stroke Scale at 24 months	1,3,6,12 and 24months
Change from baseline in mRS at 24 months	1,3,6,12 and 24months
Change from baseline in Barthel Index at 24 months	1,3,6,12 and 24months
Improvement of vision measured by brain visual examination	1,3,6,12 and 24months

Trial Locations

Locations (1)

Zhujiang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China