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.

Sponsor

R-Bio (Industry)

Overall Status

Completed

CT.gov ID

NCT03000712

Collaborator

(none)

Enrollment

Location

Arms

42.6

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Degenerative Arthritis Knee Osteoarthritis	Biological: Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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.

Actual Study Start Date :

Nov 2, 2016

Actual Primary Completion Date :

May 22, 2020

Actual Study Completion Date :

May 22, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Autologous Adipose Tissue derived MSCs Biological: Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml, 1 time injection(at 1week after high tibial osteotomy)	Biological: Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml biological : Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml drug: saline solution Other Names: JOINTSTEM
No Intervention: No treatment No treatment (after high tibial osteotomy)

Arm

Intervention/Treatment

Experimental: Autologous Adipose Tissue derived MSCs

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

Biological: Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml

biological : Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml drug: saline solution

Other Names:

JOINTSTEM

No Intervention: No treatment

No treatment (after high tibial osteotomy)

Outcome Measures

Primary Outcome Measures

MRI scan [24 months]
MRI perform to measure cartilage defect size change from baseline up to 27 weeks

Secondary Outcome Measures

MRI scan [15, 27 weeks, 18, 24 months]
MRI perform to measure cartilage defect size change from baseline up to 15 weeks
WOMAC score [15, 27 weeks, 18, 24 months]
Change in WOMAC Total score from baseline 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
Kellgren & Lawrence grade [15, 27 weeks, 18, 24 months]
Change in Kellgren & Lawrence grade 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)
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
PSQI(Pittsburgh Sleep Quality Index) [15, 27 weeks, 18, 24 months]
Change in PSQI from baseline up to 15, 27 weeks
Biomarkers [15, 27 weeks, 18, 24 months]
Change from baseline in Biomarkers up to 15, 27 weeks
Incidence of adverse reactions and characteristics associated with investigational product [15, 27 weeks, 18, 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
BMI≤30
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
Patients who have been diagnosed with malignancy within 5 years before screening (except for patients who were completely remissioned three years before screening criteria)
Patients who the principal investigator consider inappropriate for the clinical trial due to any other reasons
Patients who received concomitant contraindications and who have not passed the prescribed wash-out period before participating in the clinical trial