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Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke

NCT ID: NCT02564328

Last Updated: 2015-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke

Keywords

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Stroke Bone Marrow Mesenchymal Stem Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intravenous stem cell transplantation

Intravenous transplantation of autologous bone marrow mesenchymal stem cell plus conventional treatment include rehabilitation

Group Type ACTIVE_COMPARATOR

Intravenous stem cell transplantation

Intervention Type GENETIC

Intravenous injection of autologous bone marrow mesenchymal stem cell transplantation

Conventional treatment

Control group receive conventional stroke treatment that include rehabilitation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intravenous stem cell transplantation

Intravenous injection of autologous bone marrow mesenchymal stem cell transplantation

Intervention Type GENETIC

Eligibility Criteria

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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

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Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Southern Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Xiaodan Jiang

Zhujiang Hospital,Southern Medical University, China

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaodan Jiang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Southern Medical University

Locations

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Xiaodan Jiang

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaodan Jiang, MD,PhD

Role: CONTACT

Phone: 86 20 61643268

Email: [email protected]

Facility Contacts

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Xiaodan Jiang, MD,PhD

Role: primary

Other Identifiers

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201400000003-2

Identifier Type: -

Identifier Source: org_study_id