Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect

May 8, 2017 updated by: Shenzhen Hornetcorn Bio-technology Company, LTD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

20

Phase

  • 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, 510000
        • The Fifth Affiliated Hospital Immunotherapy center

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • hUC-MSC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before and 1,3,6,12 month after treatment
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.
Before and 1,3,6,12 month after treatment

Collaborators and Investigators

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

Sponsor

Shenzhen Hornetcorn Bio-technology Company, LTD

Collaborators

The Fifth Affiliated Hospital of Guangzhou Medical University

Investigators

  • Principal Investigator: Ping J Chen, Professor, The Fifth Affiliated Hospital of Guangzhou Medical University

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

December 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimate)

November 17, 2014

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYK-Articular Cartilage Defect

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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