Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect

NCT ID: NCT02291926

Last Updated: 2017-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Cartilage Diseases Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hUC-MSC treatment

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

Group Type EXPERIMENTAL

Human umbilical cord mesenchymal stem cells

Intervention Type BIOLOGICAL

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

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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hUC-MSC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fifth Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Shenzhen Hornetcorn Bio-technology Company, LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ping J Chen, Professor

Role: PRINCIPAL_INVESTIGATOR

Fifth Affiliated Hospital of Guangzhou Medical University

Locations

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The Fifth Affiliated Hospital Immunotherapy center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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HYK-Articular Cartilage Defect

Identifier Type: -

Identifier Source: org_study_id

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