Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.
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ClinicalTrials.gov Identifier: NCT04234412 |
Recruitment Status :
Not yet recruiting
First Posted : January 21, 2020
Last Update Posted : January 21, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
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Osteoarthritis, Knee | Procedure: umbilical cord blood stem cell implantation for osteoarthritis treatment | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Masking Description: | only case series of the treated patients |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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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.
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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

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Ages Eligible for Study: | 30 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
Responsible Party: | Seckjung Kim, Professor, Uijeongbu St. Mary Hospital |
ClinicalTrials.gov Identifier: | NCT04234412 |
Other Study ID Numbers: |
UC19OISI0134 |
First Posted: | January 21, 2020 Key Record Dates |
Last Update Posted: | January 21, 2020 |
Last Verified: | January 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | according to patient agreement, this is flexible. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
osteoarthritis knee high tibial osteotomy umbilical cord blood stem cell cartilage regeneration |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |