Single-center, Randomized, Open Label, Negative-controlled Investigator Initiated Trial to Evaluate the Efficacy and Safety of Intra-articular Injection of ADMSC(Autologous Adipose Tissue Derived Mesenchymal Stem Cells) After High Tibial Osteotomy Compared to Negative Control in the Osteoarthritis Patients.

R-Bio1 site in 1 country26 target enrollmentNovember 2, 2016

ConditionsDegenerative Arthritis Knee Osteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Degenerative Arthritis
Sponsor: R-Bio
Enrollment: 26
Locations: 1
Primary Endpoint: MRI scan
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of intra-articular injection of autologous adipose tissue derived mesenchymal stem cells compared after high tibial osteotomy to negative control in the osteoarthritis patients

Detailed Description

In this clinical trial, the investigational product is administered intra-articularly at 1 week after high tibial osteotomy in a patient with degenerative arthritis of the medial side. The investigational product is autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissue and is incubated without additional genetic modification or mechanical and chemical modification through differentiation, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection. It primarily aims to regenerate cartilage, to improve pain and joint function. The intra-articular injection of the investigational product is expected to stimulate the regeneration and growth of cartilage, and to innovatively improve pain and joint function with cartilage regeneration compared to high tibial osteotomy alone.

Registry

clinicaltrials.gov

Start Date

November 2, 2016

End Date

May 22, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

R-Bio

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must consent in writing to participate in the study by signing and dating an informed consent document
•Patients who can communicate (exclusion of anyone who cannot understand the questionnaire)
•between 20 years and 80 years of age
•Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
•Diagnosis of osteoarthritis by ACR(American College of Rheumatology Criteria) Global functional criteria : There is the pain of the knee and radiographic osteophyte and at least one of the following (1) age \>50 years (2) Less than 30 minutes of morning stiffness (3) The friction When moving weighted the knee
•Patients who agree with contraception
•Patients who agree to stop the existing osteoarthritis treatment and to get enough washout periods until medication time
•Patients scheduled for High tibial osteotomy due to medial gonarthrosis

Exclusion Criteria

•patients with osteoporosis
•Preparing for Pregnancy or Pregnant women or lactating mothers.
•Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), venereal disease research laboratory(VDRL)
•Patients with hypersensitivity to investigator product or investigational product component or those with a history
•Patients who had participated in other clinical trials within 12 weeks prior to this study
•Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment.
•Patients who experienced as the knee joint cartilage and stem cell therapy or failure to treat
•Patents who started or changed the physical therapy program established within 2 weeks before the start of the study or during the study(An established physical therapy program may continue for the duration of the trial, provided that it does not change in frequency and intensity)
•Patents included in the following specific risk groups that may influence safety and efficacy assessments at the discretion of the investigator:: septic arthtritis, rheumatic disease, gout, recurrent pseudogout, paget disease, joint fracture, alcaptonuria, acromegaly, hemochromatosis, wilson's disease, primary osteochondrosis, hereditary disorder(ex: hyperkinesia), collagen gene abnormality ,etc
•Patients who have clinically significant severe medical illnesses judged the principal investigator

Outcomes

Primary Outcomes

MRI scan

Time Frame: 24 months

MRI perform to measure cartilage defect size change from baseline up to 27 weeks

Secondary Outcomes

WOMAC score(15, 27 weeks, 18, 24 months)
PSQI(Pittsburgh Sleep Quality Index)(15, 27 weeks, 18, 24 months)
EQ5D(15, 27 weeks, 18, 24 months)
ROM(15, 27 weeks, 18, 24 months)
KOOS (Knee Injury & Osteoarthritis Outcome Score)(15, 27 weeks, 18, 24 months)
Incidence of adverse reactions and characteristics associated with investigational product(15, 27 weeks, 18, 24 months)
MRI scan(15, 27 weeks, 18, 24 months)
Kellgren & Lawrence grade(15, 27 weeks, 18, 24 months)
PGIC(Patient Global Impression of Change)(15, 27 weeks, 18, 24 months)
Biomarkers(15, 27 weeks, 18, 24 months)
WOMAC sub-scale(15, 27 weeks, 18, 24 months)