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

April 1, 2021 updated by: Zhen-Zhou Chen, Southern Medical University, China

Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Patients With Ischemic Stroke: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510282
        • Zhujiang Hospital, Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control group
Genetic: IV infusion of placebo
IV infusion of saline plus 5% autologous serum.
Other Names:
  • Placebo control group
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 Names:
  • Autologous endothelial progenitor cells transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events after infusion of BMSCs or EPCs.
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern Medical University, China

Collaborators

Cellonis Biotechnology Co. Ltd.
The Second People's Hospital of Nanhai District of Foshan
The First People's Hospital of Haizhu District Guangzhou

Investigators

  • Principal Investigator: Zhenzhou Chen, MD., phD., Department of Neurosurgery, Zhujiang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

November 2, 2011

First Submitted That Met QC Criteria

November 6, 2011

First Posted (ESTIMATE)

November 9, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2021

Last Update Submitted That Met QC Criteria

April 1, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJH-001
  • 2011A030400007 (OTHER_GRANT: The Key project of Guangdong Science and Technology Program)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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