Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04234412|
Recruitment Status : Not yet recruiting
First Posted : January 21, 2020
Last Update Posted : January 21, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Procedure: umbilical cord blood stem cell implantation for osteoarthritis treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||only case series of the treated patients|
|Official Title:||Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.|
|Estimated Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||November 30, 2022|
|Estimated Study Completion Date :||November 30, 2022|
Experimental: Osteoarthritic knee patients
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
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.
- International Cartilage Repair Society (ICRS) grade improvement [ Time Frame: at 24, 48, 96 weeks after surgery, score changes will be observed. ]over grade 1 should be improved
- Visual analogue scale (VAS) [ Time Frame: at 24, 48, 96 weeks after surgery, score changes will be observed. ]0-10 score range, lower the better
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: at 24, 48, 96 weeks after surgery, score changes will be observed. ]0-100 score range, lower the better
- International Knee Documentation Committee (IKDC score) [ Time Frame: at 24, 48, 96 weeks after surgery, score changes will be observed. ]0-100 % range, lower the better