Autologous Endothelial Progenitor Cells Transplantation for Chronic Ischemic Stroke

NCT ID: NCT02605707

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2020-02-29

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intravenous stem cell transplantation

Intravenous transplantation of autologous endothelial progenitor cells plus conventional treatment include rehabilitation

Group Type: EXPERIMENTAL

Intravenous stem cell transplantation

Intervention Type: DRUG

Intravenous injection of autologous endothelial progenitor cells transplantation

Conventional treatment

Control group receive conventional stroke treatment that include rehabilitation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intravenous stem cell transplantation

Intravenous injection of autologous endothelial progenitor cells transplantation

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Southern Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Zhen-Zhou Chen

Department of Neurosurgery, Zhujiang Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ZhenZhou Chen, MD, phD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, Zhujiang Hospital

Locations

Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2011Y1-00033-6

Identifier Type: -

Identifier Source: org_study_id