search
Back to results

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

Primary Purpose

Stroke, Infarction, Middle Cerebral Artery

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Autologous BMSCs transplantation
Autologous EPCs transplantation
IV infusion of placebo
Sponsored by
Southern Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring 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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhujiang Hospital, Southern Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

BMSCs group

EPCs group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Number of adverse events after infusion of BMSCs or EPCs.

Secondary Outcome Measures

Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI).

Full Information

First Posted
November 2, 2011
Last Updated
April 1, 2021
Sponsor
Southern Medical University, China
Collaborators
The Second People's Hospital of Nanhai District of Foshan, The First People's Hospital of Haizhu District Guangzhou, Cellonis Biotechnology Co. Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01468064
Brief Title
Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Ischemic Stroke
Acronym
AMETIS
Official Title
Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Patients With Ischemic Stroke: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern Medical University, China
Collaborators
The Second People's Hospital of Nanhai District of Foshan, The First People's Hospital of Haizhu District Guangzhou, Cellonis Biotechnology Co. Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Infarction, Middle Cerebral Artery
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BMSCs group
Arm Type
Experimental
Arm Title
EPCs group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Genetic
Intervention Name(s)
Autologous BMSCs transplantation
Other Intervention Name(s)
Autologous Bone marrow stromal cells transplantation, Autologous Mesenchymal stem cells transplantation
Intervention Description
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.
Intervention Type
Genetic
Intervention Name(s)
Autologous EPCs transplantation
Other Intervention Name(s)
Autologous endothelial progenitor cells transplantation
Intervention Description
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.
Intervention Type
Genetic
Intervention Name(s)
IV infusion of placebo
Other Intervention Name(s)
Placebo control group
Intervention Description
IV infusion of saline plus 5% autologous serum.
Primary Outcome Measure Information:
Title
Number of adverse events after infusion of BMSCs or EPCs.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI).
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18 to 80 years, within 7 days of the onset of symptoms Ischemic lesion within the MCA territory as assessed using diffusion-weighted imaging (DWI) The National Institutes of Health Stroke Scale (NIHSS) ≥ 7 at day 7 after the onset Signed informed consent Exclusion Criteria: Lacunar syndrome Diagnosis other than ischemic stroke(eg. Intracranial hemorrhage or Intracranial tumor) Hematological causes of stroke Severe respiratory, hepatic, or renal disorders Presence of severe febrile illness or viral diseases Malignant diseases Presence of autoimmune diseases Positive response of penicillin skin test, or multiple drug allergies Breast-feeding or pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenzhou Chen, MD., phD.
Organizational Affiliation
Department of Neurosurgery, Zhujiang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhujiang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
20506226
Citation
Lee JS, Hong JM, Moon GJ, Lee PH, Ahn YH, Bang OY; STARTING collaborators. A long-term follow-up study of intravenous autologous mesenchymal stem cell transplantation in patients with ischemic stroke. Stem Cells. 2010 Jun;28(6):1099-106. doi: 10.1002/stem.430.
Results Reference
background
PubMed Identifier
15929052
Citation
Bang OY, Lee JS, Lee PH, Lee G. Autologous mesenchymal stem cell transplantation in stroke patients. Ann Neurol. 2005 Jun;57(6):874-82. doi: 10.1002/ana.20501.
Results Reference
background
PubMed Identifier
30156755
Citation
Fang J, Guo Y, Tan S, Li Z, Xie H, Chen P, Wang K, He Z, He P, Ke Y, Jiang X, Chen Z. Autologous Endothelial Progenitor Cells Transplantation for Acute Ischemic Stroke: A 4-Year Follow-Up Study. Stem Cells Transl Med. 2019 Jan;8(1):14-21. doi: 10.1002/sctm.18-0012. Epub 2018 Aug 29.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs