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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by Southern Medical University, China
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
ClinicalTrials.gov Identifier:
NCT01468064
First received: November 2, 2011
Last updated: November 8, 2011
Last verified: November 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Patients With Ischemic Stroke: a Double-blind, Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Southern Medical University, China:

Primary Outcome Measures:
  • Number of adverse events after infusion of BMSCs or EPCs. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

This study is a multi-center, double-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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468064

Contacts
Contact: Zhen-Zhou Chen, MD., phD. +86-20-62782768 czz1020@163.com
Contact: Yi-Quan Ke, MD., phD. +86-20-61643266 kyquan@fimmu.com

Locations
China, Guangdon
Zhujiang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdon, 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: Zhen-Zhou Chen, MD., phD. Department of Neurosurgery, Zhujiang Hospital
  More Information

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
Study First Received: November 2, 2011
Last Updated: November 8, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by 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:
Infarction
Stroke
Cerebral Infarction
Infarction, Middle Cerebral Artery
Ischemia
Pathologic Processes
Necrosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Cerebral Arterial Diseases
Intracranial Arterial Diseases

ClinicalTrials.gov processed this record on August 26, 2014