NCT04234412

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

2.8 years

First QC Date

January 5, 2020

Last Update Submit

January 15, 2020

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritiskneehigh tibial osteotomyumbilical cord blood stem cellcartilage regeneration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Visual analogue scale (VAS)

    at 24, 48, 96 weeks after surgery, score changes will be observed.

  • Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    at 24, 48, 96 weeks after surgery, score changes will be observed.

  • International Knee Documentation Committee (IKDC score)

    at 24, 48, 96 weeks after surgery, score changes will be observed.

Study Arms (1)

Osteoarthritic knee patients

EXPERIMENTAL

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

Interventions

umbilical cord blood stem cell implantation for osteoarthritis treatmentPROCEDURE

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.

Osteoarthritic knee patients

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • ligament injuries (such as injuries of the anterior cruciate ligament and posterior cruciate ligament),
  • metabolic arthritis
  • infectious condition
  • psychosis
  • serious medical illness
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bae BS, Jung JW, Jo GO, Kim SA, Go EJ, Cho ML, Shetty AA, Kim SJ. Treatment of osteoarthritic knee with high tibial osteotomy and allogeneic human umbilical cord blood-derived mesenchymal stem cells combined with hyaluronate hydrogel composite. Stem Cell Res Ther. 2025 Apr 28;16(1):211. doi: 10.1186/s13287-025-04356-9.

    PMID: 40296133DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
only case series of the treated patients
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 21, 2020

Study Start

February 1, 2020

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

January 21, 2020

Record last verified: 2020-01