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

NCT01468064 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-04-02

No results posted yet for this study

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.

Conditions

  • Stroke
  • Infarction, Middle Cerebral Artery

Interventions

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.

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.

GENETIC

IV infusion of placebo

IV infusion of saline plus 5% autologous serum.

Sponsors & Collaborators

  • The Second People's Hospital of Nanhai District of Foshan

    collaborator UNKNOWN

  • The First People's Hospital of Haizhu District Guangzhou

    collaborator OTHER

  • Cellonis Biotechnology Co. Ltd.

    collaborator INDUSTRY

  • Southern Medical University, China

    lead OTHER

Principal Investigators

  • Zhenzhou Chen, MD., phD. · Department of Neurosurgery, Zhujiang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-12-31
Completion
2017-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01468064 on ClinicalTrials.gov