Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical results after implantation of human umbilical cord blood-derived mesenchymal stem cells(hUCB-MSCs) and High tibia osteotomy in patients with medial compartment osteoarthritis(MCOA) as well as varus deformity of the knee joint. This study will prospectively evaluate 10 knees after hUCB-MSCs implantation and High Tibial Osteotomy(HTO) in the medial compartment osteoarthritis and varus deformity of the knee joint. Clinical outcomes will be evaluated using the International Knee Documentation committee(IKDC), Visual analogue scale(VAS), Western Ontario and McMaster Universities Arthritis Index(WOMAC), and patients satisfaction with the surgery.

Official Title
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Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: umbilical cord blood stem cell implantation for osteoarthritis treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age older than 30 years, full-thickness cartilage lesion measuring at least 2 cm2, femoro-tibial angle (varus or valgus) 5°< in the mechanical axis Exclusion Criteria: ligament injuries (such as injuries of the anterior cruciate ligament and posterior cruciate ligament), metabolic arthritis infectious condition psychosis serious medical illness pregnancy

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 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: Osteoarthritic knee patients<br>Osteoarthritic Knee of the patients who will be treated wth high tibial osteotomy and implantation of allogenic human umbilical cord blood-derived stem cells. | Procedure: umbilical cord blood stem cell implantation for osteoarthritis treatment<br>* The arthroscopic procedure is performed in the supine position after spinal anesthesia. Once the chondral lesion is identified through a standard anteromedial and lateral portal, meniscectomy, meniscal repair, and lateral retinacular release are performed if necessary. microfracture is performed using a microfracture awl. Once both the unstable cartilage and subchondral bone are removed in the lesion area and the sclerotic bone is peeled slightly by using a burr, hole(s) are created for implantation by using a drill bit(diameter 4; depth: 4mm). After implantation is performed in the hole by injecting the mixture of sodium hyaluronate and hUCB-MSCs, it is trimmed to the height of the surrounding articular surface.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Cartilage Repair Society (ICRS) grade improvement | over grade 1 should be improved | at 24, 48, 96 weeks after surgery, score changes will be observed. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) | 0-10 score range, lower the better | at 24, 48, 96 weeks after surgery, score changes will be observed. | 
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 0-100 score range, lower the better | at 24, 48, 96 weeks after surgery, score changes will be observed. | 
| International Knee Documentation Committee (IKDC score) | 0-100 % range, lower the better | at 24, 48, 96 weeks after surgery, score changes will be observed. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, knee, high tibial osteotomy, umbilical cord blood stem cell, cartilage regeneration