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

Uijeongbu St. Mary Hospital

Status: Unknown

Conditions: Osteoarthritis, Knee

Treatments: Procedure: umbilical cord blood stem cell implantation for osteoarthritis treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04234412

UC19OISI0134

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Osteoarthritic knee patients

Experimental group

Description:

Osteoarthritic Knee of the patients who will be treated wth high tibial osteotomy and implantation of allogenic human umbilical cord blood-derived stem cells.

Treatment:

Procedure: umbilical cord blood stem cell implantation for osteoarthritis treatment