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Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Ischemic Stroke (AMETIS)

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ClinicalTrials.gov Identifier: NCT01468064
Recruitment Status : Unknown
Verified November 2015 by Zhen-Zhou Chen, Southern Medical University, China.
Recruitment status was:  Recruiting
First Posted : November 9, 2011
Last Update Posted : November 13, 2015
Sponsor:
Collaborators:
The Second People's Hospital of Nanhai District of Foshan
The First People's Hospital of Haizhu District Guangzhou
Cellonis Biotechnology Co. Ltd.
Information provided by (Responsible Party):
Zhen-Zhou Chen, Southern Medical University, China

Brief Summary:
The purpose of this study is to evaluate the feasibility, efficacy, and safety of autologous transplantation of ex vivo expanded bone marrow stromal cells (BMSCs)and endothelial progenitor cells (EPCs) for treatment of patients with ischemic stroke.

Condition or disease Intervention/treatment Phase
Stroke Infarction, Middle Cerebral Artery Genetic: Autologous BMSCs transplantation Genetic: Autologous EPCs transplantation Genetic: IV infusion of placebo Phase 1 Phase 2

Detailed Description:
This study is a multi-center, single-blind, randomized, parallel controlled trail. Patients with acute cerebral infarcts within the middle cerebral arterial territory and with severe neurological deficits will be enrolled and randomly allocated into 3 groups: autologous BMSCs transplantation group, autologous EPCs transplantation group and Placebo control group. Randomization codes were established by the study statistician and were revealed only to the stem cell laboratory technician responsible for separating the cells into aliquots or preparing the placebo material. All patients will undergo a Bone Marrow aspiration procedure at 7 days after symptom onset. BMSCs and EPCs will be expanded ex vivo and then intravenously infused into own body, respectively. The control group will not receive cell therapy. Observe will followed for up to 1 year after the onset. Neurological score, neuroimaging, mortality of any cause, side effects, and new-onset comorbidities will be monitored and compared between each groups.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Patients With Ischemic Stroke: a Randomized Controlled Trial
Study Start Date : November 2011
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Arm Intervention/treatment
Experimental: BMSCs group Genetic: Autologous BMSCs transplantation

The first transplantation: 2.5 million cells per kg autologous BMSCs suspended in 100 ml saline plus 5% autologous serum are infused intravenously approximately 4 weeks after bone marrow aspiration.

The second transplantation: the same amount of cells are again transplanted approximately 1 weeks after initial boosting.

Other Names:
  • Autologous Bone marrow stromal cells transplantation
  • Autologous Mesenchymal stem cells transplantation

Experimental: EPCs group Genetic: Autologous EPCs transplantation

The first transplantation: 2.5 million cells per kg autologous EPCs suspended in 100 ml saline plus 5% autologous serum are infused intravenously approximately 4 weeks after bone marrow aspiration.

The second transplantation: the same amount of cells are again transplanted approximately 1 weeks after initial boosting.

Other Name: Autologous endothelial progenitor cells transplantation

Placebo Comparator: Control group Genetic: IV infusion of placebo
IV infusion of saline plus 5% autologous serum.
Other Name: Placebo control group




Primary Outcome Measures :
  1. Number of adverse events after infusion of BMSCs or EPCs. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI). [ Time Frame: 1 year ]


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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:

  1. Patients aged 18 to 80 years, within 7 days of the onset of symptoms
  2. Ischemic lesion within the MCA territory as assessed using diffusion-weighted imaging (DWI)
  3. The National Institutes of Health Stroke Scale (NIHSS) ≥ 7 at day 7 after the onset
  4. Signed informed consent

Exclusion Criteria:

  1. Lacunar syndrome
  2. Diagnosis other than ischemic stroke(eg. Intracranial hemorrhage or Intracranial tumor)
  3. Hematological causes of stroke
  4. Severe respiratory, hepatic, or renal disorders
  5. Presence of severe febrile illness or viral diseases
  6. Malignant diseases
  7. Presence of autoimmune diseases
  8. Positive response of penicillin skin test, or multiple drug allergies
  9. Breast-feeding or pregnant women

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): NCT01468064


Contacts
Contact: Zhenzhou Chen, MD., phD. +86-20-62782768 czz1020@163.com
Contact: Yiquan Ke, MD., phD. +86-20-61643266 kyquan@fimmu.com

Locations
China, Guangdong
Zhujiang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510282
Contact: Zhen-Zhou Chen, MD., phD.    +86-20-62782768    czz1020@163.com   
Contact: Yi-Quan Ke, MD., phD.    +86-20-61643266    kyquan@fimmu.com   
Principal Investigator: Zhen-Zhou Chen, MD., phD.         
Sponsors and Collaborators
Southern Medical University, China
The Second People's Hospital of Nanhai District of Foshan
The First People's Hospital of Haizhu District Guangzhou
Cellonis Biotechnology Co. Ltd.
Investigators
Principal Investigator: Zhenzhou Chen, MD., phD. Department of Neurosurgery, Zhujiang Hospital

Publications:
Responsible Party: Zhen-Zhou Chen, Department of Neurosurgery, Zhujiang Hospital, Southern Medical University, China
ClinicalTrials.gov Identifier: NCT01468064     History of Changes
Other Study ID Numbers: ZJH-001
2011A030400007 ( Other Grant/Funding Number: The Key project of Guangdong Science and Technology Program )
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015

Keywords provided by Zhen-Zhou Chen, Southern Medical University, China:
Central Nervous System Diseases
Stroke
Infarction, Middle Cerebral Artery
Cerebral Infarction
Cerebrovascular Accident
Stem Cell Transplantation
Mesenchymal Stem Cell Transplantation
Bone marrow stromal cells
Mesenchymal Stem Cells
Endothelial progenitor cells
Adult Stem Cells
Cell Therapy

Additional relevant MeSH terms:
Stroke
Infarction
Infarction, Middle Cerebral Artery
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebral Arterial Diseases
Intracranial Arterial Diseases