UCMSC Transplantation in the Treatment of Cartilage Damage

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy and safety of transplantation of umbilical cord mesenchymal stem cells（UCMSCs） in patient with Knee cartilage damage.

Detailed Description
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Human cartilage only has limited regenerative potential. Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) is a promising strategy given the high proliferative capacity of MSCs and their potential to differentiate into cartilage-producing cells - chondrocytes. The acquisition of ucMSCs does not require invasive surgical intervention or cartilage extraction from other sites as required by other cell-based strategies. The investigators inject allogeneic human mesenchymal stem cells to the cartilage lesions in patients via intra-articular injection method, and to investigate the efficacy and safety。

Official Title
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Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee and Knee Osteoarthritis

Conditions
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Cartilage Damage, Degenerative Osteoarthritis

Intervention / Treatment
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* Biological: umbilical cord mesenchymal stem cells
* Device: Hyaluronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients whose lesion (single joint) should be in the range of 2 cm^2-8 cm^2. Patients with pain in affected joint of 60 mm- 100 mm VAS (visual analogue scale) Patients with articular swelling, tenderness and active range of motion of Grade 2 or below Patients with knee joint cartilage defect or injury of ICRS (International Cartilage Repair Society) Grade 4 confirmed by arthroscopy (At screening, patients diagnosed as such with an MRI may be included) Patients who needs invasive interventions of arthroplasty due to no response from existing pain medication Patients voluntarily agreed to participate in the study and signed informed consent Exclusion Criteria: Patients with autoimmune diseases or medical history Patients with infections requiring injection of antibiotics Patients with severe internal diseases Patients who are currently pregnant or lactation Patients who had participated in any other clinical trials within the past four weeks Patients who had been administered with immunosuppressants within the past four weeks Patients whom the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stem cell treatment<br>Umbilical Cord Mesenchymal stem cells (UCMSC) expanded and treated for 1-2 weeks. Then administer 5x10^6 of UCMSC per cm^2 of the cartilage defect. | Biological: umbilical cord mesenchymal stem cells<br> <br> * Other names: UCMSC;|
| Active Comparator: Hyaluronic acid treatment<br>Administer hyaluronic acid (30 mg) in a single injection | Device: Hyaluronic acid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Function Change and Improvement | Knee assessments will be performed using the following tools: Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 12 months after treatment | 
| Knee Function Change and Improvement | Changes in knee function will be assessed via the IKDC score. | 12 months after treatment | 

Secondary 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 |