Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Stroke

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-12-31

Brief Summary

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Stroke is one of the leading causes of disability in the world, and stem cell - transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.

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Detailed Description

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For many stroke survivors, the best hope is a lengthy program of rehabilitation, followed by a life-long process of clinical support. However, even with rehabilitation therapy, 50% to 95% of stroke survivors remain impaired. There is thus a great need for new therapeutic developments for patients with disability after stroke, which is largely unexplored. Regenerative cell-based therapies offer long-term hope for many patients with stroke, as stem cells might be possible for dead or injured neural cells to be replaced after acute stroke. 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 stroke. The neurological outcome will be determined after transplantation.

Conditions

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Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intracerebral stem cell transplantation

Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient plus conventional treatment include rehabilitation

Group Type ACTIVE_COMPARATOR

intracerebral stem cell transplantation

Intervention Type GENETIC

Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient

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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intracerebral stem cell transplantation

Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Aged 40-70 ischemia stroke or intracerebral hemorrhage patient
* With stroke history of more than 3 months, less than 60 months
* With stable hemiplegia condition
* NIHSS (NIH stroke scale) score of 7 or more points
* Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar \<7 mg, and normal urea/electrolytes for at least 48 hours.)

Exclusion Criteria

* Patients aged less than 40 or more than 70
* Lacunar infarction
* History of neurological disease, head injury or psychiatric disorder with disablity
* Pregnant women
* Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition
* Inaccessibility for follow up
* Unwillingness to provide written informed consent

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No