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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect

NCT02291926

Cartilage Diseases Osteoarthritis

COMPLETED PHASE1

UCMSC Transplantation in the Treatment of Cartilage Damage

NCT02776943

Cartilage Damage Degenerative Osteoarthritis

UNKNOWN PHASE1/PHASE2

Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord Blood for Osteoarthritis Management

NCT03800810

Osteoarthritis, Knee

UNKNOWN EARLY_PHASE1

Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Knee Osteoarthritis

NCT05160831

Knee Osteoarthritis

UNKNOWN NA

Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product

NCT02338375

Osteochondral Lesion of Talus

UNKNOWN EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

only case series of the treated patients

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

umbilical cord blood stem cell implantation for osteoarthritis treatment

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No