We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291926
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : May 10, 2017
Sponsor:
Collaborator:
Fifth Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Shenzhen Hornetcorn Bio-technology Company, LTD

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Cartilage Diseases Osteoarthritis Biological: Human umbilical cord mesenchymal stem cells Phase 1

Detailed Description:

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Human Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee
Study Start Date : December 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: hUC-MSC treatment
Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
 Biological: Human umbilical cord mesenchymal stem cells
A single dose of 2×107 hUC-MSC will be implanted to patients by intra-articular injection, and repeated every month for four times.
Other Name: hUC-MSC


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must consent in writing to participate in the study by signing and dating an informed consent document
  • Healthy patients with no major history of illness
  • Patients must have a diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
  • Patients who needs invasive interventions of arthroplasty due to no response from existing pain medication
  • Patients must have had more than Grade 4 (0~10 point numeric scale) pain at least for four months
  • Patient's damaged cartilage area should be in the range of 2-6cm2

Exclusion Criteria:

  • Pregnant women or lactating mothers
  • Patients who have received any anti-inflammatory drugs including herb-drug within 14 days
  • Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment
  • Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection
  • Impaired liver function, abnormal blood coagulation, combine other tumor or special condition
  • Patients who had participated in other clinical trials within three months prior to this study
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291926


Locations
Layout table for location information
China, Guangdong
The Fifth Affiliated Hospital Immunotherapy center
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Shenzhen Hornetcorn Bio-technology Company, LTD
Fifth Affiliated Hospital of Guangzhou Medical University
Investigators
Layout table for investigator information
Principal Investigator: Ping J Chen, Professor Fifth Affiliated Hospital of Guangzhou Medical University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Shenzhen Hornetcorn Bio-technology Company, LTD
ClinicalTrials.gov Identifier: NCT02291926    
Other Study ID Numbers: HYK-Articular Cartilage Defect
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: July 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shenzhen Hornetcorn Bio-technology Company, LTD:
Human Umbilical Cord Mesenchymal Stem Cell
Mesenchymal Stem Cell
Osteoarthritis
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Cartilage Diseases
Arthritis
Joint Diseases
 Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases