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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

Tracking Information
First Submitted Date  ICMJE November 7, 2014
First Posted Date  ICMJE November 17, 2014
Last Update Posted Date May 10, 2017
Study Start Date  ICMJE December 2014
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2014)		 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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2017)
  • 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 Measures  ICMJE
 (submitted: November 12, 2014)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect
Official Title  ICMJE 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cartilage Diseases
  • Osteoarthritis
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: hUC-MSC treatment
Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
Intervention: Biological: Human umbilical cord mesenchymal stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2014)		 20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02291926
Other Study ID Numbers  ICMJE HYK-Articular Cartilage Defect
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Shenzhen Hornetcorn Bio-technology Company, LTD
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Shenzhen Hornetcorn Bio-technology Company, LTD
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Fifth Affiliated Hospital of Guangzhou Medical University
Investigators  ICMJE
Principal Investigator: Ping J Chen, Professor Fifth Affiliated Hospital of Guangzhou Medical University
PRS Account Shenzhen Hornetcorn Bio-technology Company, LTD
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP