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Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT02564328
Recruitment Status : Unknown
Verified September 2015 by Xiaodan Jiang, Southern Medical University, China.
Recruitment status was:  Recruiting
First Posted : September 30, 2015
Last Update Posted : September 30, 2015
Sponsor:
Collaborator:
Second Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Xiaodan Jiang, 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 bone marrow mesenchymal stem cells in patients with chronic stroke.

Condition or disease Intervention/treatment Phase
Stroke Genetic: Intravenous stem cell transplantation Phase 1

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 bone marrow mesenchymal stem cells in patients with chronic ischemic stroke. The neurological outcome will be determined after transplantation.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke
Study Start Date : November 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2017

Arm Intervention/treatment
Active Comparator: Intravenous stem cell transplantation
Intravenous transplantation of autologous bone marrow mesenchymal stem cell plus conventional treatment include rehabilitation
Genetic: Intravenous stem cell transplantation
Intravenous injection of autologous bone marrow mesenchymal stem cell transplantation

No Intervention: Conventional treatment
Control group receive conventional stroke treatment that include rehabilitation



Primary Outcome Measures :
  1. Change from baseline in Fugl-Meyer Scale at 12 months [ Time Frame: 1,3,6 and 12 months ]

Secondary Outcome Measures :
  1. Change from baseline in NIH Stroke Scale at 12 months [ Time Frame: 1,3,6 and 12 months ]
  2. Change from baseline in Barthel Index at 12 months [ Time Frame: 1,3,6 and 12 months ]
  3. Change from baseline in SSS at 12 months [ Time Frame: 1,3,6 and 12 months ]
  4. Change from baseline in mRS at 12 months [ Time Frame: 1,3,6 and 12 months ]
  5. Improvement of vision measured by brain visual examination [ Time Frame: 1,6 and 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564328


Contacts
Contact: Xiaodan Jiang, MD,PhD 86 20 61643268 jiangxiao_dan@163.com

Locations
China, Guangdong
Xiaodan Jiang Recruiting
Guangzhou, Guangdong, China, 510282
Contact: Xiaodan Jiang, MD,PhD    86 20 61643268    jiangxiao_dan@163.com   
Principal Investigator: Xiaodan Jiang, MD,PhD         
Sponsors and Collaborators
Southern Medical University, China
Second Affiliated Hospital of Guangzhou Medical University
Investigators
Principal Investigator: Xiaodan Jiang, MD,PhD Southern Medical University

Responsible Party: Xiaodan Jiang, Zhujiang Hospital,Southern Medical University, China, Southern Medical University, China
ClinicalTrials.gov Identifier: NCT02564328     History of Changes
Other Study ID Numbers: 201400000003-2
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015

Keywords provided by Xiaodan Jiang, Southern Medical University, China:
Stroke
Bone Marrow Mesenchymal Stem Cell
Transplantation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases