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

Not Applicable

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: umbilical cord blood stem cell implantation for osteoarthritis treatment

• Registration Number: NCT04234412
• Lead Sponsor: Uijeongbu St. Mary Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-05
• Study First Submitted QC: 2020-01-15
• Last Update Submitted: 2020-01-15
• Study First Posted: 2020-01-21
• Last Update Posted: 2020-01-21
• Study Start: 2020-02-01
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Osteoarthritic knee patients	umbilical cord blood stem cell implantation for osteoarthritis treatment	Osteoarthritic Knee of the patients who will be treated wth high tibial osteotomy and implantation of allogenic human umbilical cord blood-derived stem cells.

Primary Outcome Measures

Name	Time	Method
International Cartilage Repair Society (ICRS) grade improvement	at 24, 48, 96 weeks after surgery, score changes will be observed.	over grade 1 should be improved

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS)	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)	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)	at 24, 48, 96 weeks after surgery, score changes will be observed.	0-100 % range, lower the better