Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Stroke

Phase 1

• Conditions: Stroke
• Interventions: Genetic: intracerebral stem cell transplantation

• Registration Number: NCT01714167
• Lead Sponsor: Wenzhou Medical University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-10-19
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-25
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-04
• Last Update Posted: 2015-06-08
• Primary Completion: 2015-10
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intracerebral stem cell transplantation	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

Primary Outcome Measures

Name	Time	Method
Change from baseline in NIH Stroke Scale at 12 months	1, 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Improvement of infarct size measured by brain MRI	1,6 and 12 months after transplantation

Trial Locations

Locations (1)

The First Affiliated Hospital of Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China