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Autologous Endothelial Progenitor Cells Transplantation for Chronic Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT02605707
Recruitment Status : Unknown
Verified November 2015 by Zhen-Zhou Chen, Southern Medical University, China.
Recruitment status was:  Recruiting
First Posted : November 16, 2015
Last Update Posted : November 16, 2015
Sponsor:
Collaborator:
Second Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Zhen-Zhou Chen, 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 endothelial progenitor cells in patients with chronic stroke.

Condition or disease Intervention/treatment Phase
Stroke Drug: Intravenous stem cell transplantation Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autologous Endothelial Progenitor Cells Transplantation for Chronic Ischemic Stroke
Study Start Date : November 2014
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Arm Intervention/treatment
Experimental: Intravenous stem cell transplantation
Intravenous transplantation of autologous endothelial progenitor cells plus conventional treatment include rehabilitation
Drug: Intravenous stem cell transplantation
Intravenous injection of autologous endothelial progenitor cells 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): NCT02605707


Contacts
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Contact: ZhenZhou Chen, MD, phD czz1020@163.com

Locations
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China, Guangdong
Zhujiang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510282
Contact: Zhenzhou Chen, MD., phD.    +86-20-62782768    czz1020@163.com   
Contact: Xiaodan Jiang, MD., phD.    +86-20-61643268    jiangxiao_dan@163.com   
Principal Investigator: Zhen-Zhou Chen, MD., phD.         
Sponsors and Collaborators
Southern Medical University, China
Second Affiliated Hospital of Guangzhou Medical University
Investigators
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Principal Investigator: ZhenZhou Chen, MD, phD Department of Neurosurgery, Zhujiang Hospital

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Responsible Party: Zhen-Zhou Chen, Department of Neurosurgery, Zhujiang Hospital, Southern Medical University, China
ClinicalTrials.gov Identifier: NCT02605707     History of Changes
Other Study ID Numbers: 2011Y1-00033-6
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: November 16, 2015
Last Verified: November 2015
Keywords provided by Zhen-Zhou Chen, Southern Medical University, China:
Endothelial Progenitor Cells
Transplantation
Stroke
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases