Investigator Initiated Trial to Evaluate the Efficacy and Safety of Intra-articular Injection of ADMSC Comared to Negative Control After High Tibial Osteotomy in the Osteoarthritis Patients.

Not Applicable

Completed

• Conditions: Degenerative Arthritis; Knee Osteoarthritis
• Interventions: Biological: Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml

• Registration Number: NCT03000712
• Lead Sponsor: R-Bio

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.

Study Timeline

• Study Start: 2016-11-02
• Study First Submitted: 2016-12-18
• Study First Submitted QC: 2016-12-18
• Study First Posted: 2016-12-22
• Status Verified: 2019-06
• Primary Completion: 2020-05-22
• Study Completion: 2020-05-22
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Patients must consent in writing to participate in the study by signing and dating an informed consent document
2. Patients who can communicate (exclusion of anyone who cannot understand the questionnaire)
3. between 20 years and 80 years of age
4. BMI≤30
5. Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
6. 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
7. Patients who agree with contraception
8. Patients who agree to stop the existing osteoarthritis treatment and to get enough washout periods until medication time
9. Patients scheduled for High tibial osteotomy due to medial gonarthrosis

Exclusion Criteria

1. patients with osteoporosis
2. Preparing for Pregnancy or Pregnant women or lactating mothers.
3. Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), venereal disease research laboratory(VDRL)
4. Patients with hypersensitivity to investigator product or investigational product component or those with a history
5. Patients who had participated in other clinical trials within 12 weeks prior to this study
6. Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment.
7. Patients who experienced as the knee joint cartilage and stem cell therapy or failure to treat
8. 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)
9. 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
10. Patients who have clinically significant severe medical illnesses judged the principal investigator
11. Patients who have been diagnosed with malignancy within 5 years before screening (except for patients who were completely remissioned three years before screening criteria)
12. Patients who the principal investigator consider inappropriate for the clinical trial due to any other reasons
13. Patients who received concomitant contraindications and who have not passed the prescribed wash-out period before participating in the clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous Adipose Tissue derived MSCs	Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml	Biological: Autologous Adipose Tissue derived MSCs 1x10\^8cells/3ml, 1 time injection(at 1week after high tibial osteotomy)

Primary Outcome Measures

Name	Time	Method
MRI scan	24 months	MRI perform to measure cartilage defect size change from baseline up to 27 weeks

Secondary Outcome Measures

Name	Time	Method
WOMAC score	15, 27 weeks, 18, 24 months	Change in WOMAC Total score from baseline up to 15, 27 weeks
PSQI(Pittsburgh Sleep Quality Index)	15, 27 weeks, 18, 24 months	Change in PSQI from baseline up to 15, 27 weeks
EQ5D	15, 27 weeks, 18, 24 months	Change in the score of EQ-5D from baseline up to 15, 27 weeks
ROM	15, 27 weeks, 18, 24 months	change from baseline in knee flexion Range of Motion(ROM) at 15,27 weeks by physical examination
KOOS (Knee Injury & Osteoarthritis Outcome Score)	15, 27 weeks, 18, 24 months	Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Incidence of adverse reactions and characteristics associated with investigational product	15, 27 weeks, 18, 24 months
MRI scan	15, 27 weeks, 18, 24 months	MRI perform to measure cartilage defect size change from baseline up to 15 weeks
Kellgren & Lawrence grade	15, 27 weeks, 18, 24 months	Change in Kellgren \& Lawrence grade from baseline up to 15, 27 weeks
PGIC(Patient Global Impression of Change)	15, 27 weeks, 18, 24 months	The percentage of subjects who were evaluated as improved at 15 weeks and 27 weeks in the patient global impression of change
Biomarkers	15, 27 weeks, 18, 24 months	Change from baseline in Biomarkers up to 15, 27 weeks
WOMAC sub-scale	15, 27 weeks, 18, 24 months	Change in WOMAC sub-scale from baseline up to 15, 27 weeks

Trial Locations

Locations (1)

KyungHee University Gangdong Hospital; 🇰🇷 Seoul, Korea, Republic of