Clinical Trial: Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase I Study of Human Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for articular cartilage defect of knee.

Detailed Summary:

Human articular cartilage has limited repair potential.Cell-based strategies have explored chondrocytes and mesenchymal stem cells (MSCs) with extensive basic science and preclinical studies.However the concept of autologous chondrocyte implantation is not ideal,so the focus in cartilage repair is shifting toward mesenchymal stem cells.

To investigate the effects of hUC-MSC treatment for articular cartilage defects, 20 patients will be enrolled and receive 4 times of hUC-MSC transplantation.


Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD

Current Primary Outcome: Severity of adverse events [ Time Frame: 12 months ]

Adverse events were categorized using National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 scale (NCI-CTCAE v4.0).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Magnetic resonance imaging (MRI) of the knee [ Time Frame: Before and 1,3,6,12 month after treatment ]
    The size, depth of cartilage defect, and regenerated cartilage were measured using MRI.
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Before and 1,3,6,12 month after treatment ]
    Change in WOMAC pain score,composite score and function and stiffness index scores.


Original Secondary Outcome:

  • Magnetic resonance imaging (MRI) of the knee [ Time Frame: Before and 1,3,6,12 month after treatment ]
    The size, depth of cartilage defect, and regenerated cartilage were measured using MRI.
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Before and 1,3,6,12 month after treatment ]


Information By: Shenzhen Hornetcorn Bio-technology Company, LTD

Dates:
Date Received: November 7, 2014
Date Started: December 2014
Date Completion:
Last Updated: May 8, 2017
Last Verified: July 2015