Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect

Study Overview
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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.

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

Conditions
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Cartilage Diseases, Osteoarthritis

Intervention / Treatment
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* Biological: Human umbilical cord mesenchymal stem cells


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnetic resonance imaging (MRI) of the knee | 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) | Change in WOMAC pain score,composite score and function and stiffness index scores. | Before and 1,3,6,12 month after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Osteoarthritis