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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04234412
• Other study ID #: UC19OISI0134
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2020
• Source: Uijeongbu St. Mary Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Uijeongbu St. Mary Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual analogue scale (VAS)	0-10 score range, lower the better	at 24, 48, 96 weeks after surgery, score changes will be observed.
Secondary	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.
Secondary	International Knee Documentation Committee (IKDC score)	0-100 % range, lower the better	at 24, 48, 96 weeks after surgery, score changes will be observed.