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Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect

Primary Purpose

Cartilage Diseases, Osteoarthritis

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Human umbilical cord mesenchymal stem cells

About this trial

This is an interventional treatment trial for Cartilage Diseases focused on measuring Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Osteoarthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Fifth Affiliated Hospital Immunotherapy center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hUC-MSC treatment

Arm Description

Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.

Outcomes

Primary Outcome Measures

Severity of adverse events

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

Magnetic resonance imaging (MRI) of the knee

The size, depth of cartilage defect, and regenerated cartilage were measured using MRI.

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Change in WOMAC pain score,composite score and function and stiffness index scores.

Full Information

NCT ID

NCT02291926

First Posted

November 7, 2014

Last Updated

May 8, 2017

Sponsor

Shenzhen Hornetcorn Bio-technology Company, LTD

Collaborators

Fifth Affiliated Hospital of Guangzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02291926

Brief Title

Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shenzhen Hornetcorn Bio-technology Company, LTD

Collaborators

Fifth Affiliated Hospital of Guangzhou Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cartilage Diseases, Osteoarthritis

Keywords

Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

hUC-MSC treatment

Arm Type

Experimental

Arm Description

Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.

Intervention Type

Biological

Intervention Name(s)

Human umbilical cord mesenchymal stem cells

Other Intervention Name(s)

hUC-MSC

Intervention Description

A single dose of 2×107 hUC-MSC will be implanted to patients by intra-articular injection, and repeated every month for four times.

Primary Outcome Measure Information:

Title

Severity of adverse events

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Magnetic resonance imaging (MRI) of the knee

Description

The size, depth of cartilage defect, and regenerated cartilage were measured using MRI.

Time Frame

Before and 1,3,6,12 month after treatment

Title

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Description

Change in WOMAC pain score,composite score and function and stiffness index scores.

Time Frame

Before and 1,3,6,12 month after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ping J Chen, Professor

Organizational Affiliation

Fifth Affiliated Hospital of Guangzhou Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Fifth Affiliated Hospital Immunotherapy center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect

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