Clinical Trial to Evaluate Efficacy and Safety of JOINTSTEM in Patients With Degenerative Arthritis

Sponsor

R-Bio (Industry)

Overall Status

Completed

CT.gov ID

NCT02658344

Collaborator

(none)

Enrollment

Locations

Arms

17.1

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Knee Osteoarthritis.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Arthritis Knee Osteoarthritis	Biological: JOINTSTEM Drug: Saline solution	Phase 2

Detailed Description

JOINTSTEM is an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues 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 improve pain and joint function, and secondary, to regenerate cartilage. The intra-articular injection of JOINTSTEM is expected to stimulate the regeneration and growth of cartilage, and to innovatively improve pain and joint function with cartilage regeneration within six months.

The subjects of this therapy were regenerative patients with K&L grade 2~4 aged 18 or older. JOINTSTEM is expected to be used in patients who have significantly damage cartilage due to its cartilage regeneration ability, in addition to its improvement of pain and joint performance. A;sp. Patients who had already undergone knee arthroplasty can delay their additional surgery with the use of JOINTSTEM. For dose who still have their own cartilage, arthroplasty is not an immediate treatment option, and osteoporosis patients who cannot undergo arthroplasty due to their advanced age can receive JOINTSTEM.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Multicenter, Randomized, Double-Blind, Placebo Controlled Phase Ⅱb Clinical Trial to Evaluate Efficacy and Safety of JOINTSTEM in Patients With Degenerative Arthritis

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Jointstem Autologous Adipose Tissue derived MSCs	Biological: JOINTSTEM Jointstem (Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml), 1 time injection Other Names: Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml
Placebo Comparator: Saline solution Sodium chloride	Drug: Saline solution Saline solution (Sodium chloride 9mg/ml), 1 time injection Other Names: Sodium chloride 9mg/ml

Arm

Intervention/Treatment

Experimental: Jointstem

Autologous Adipose Tissue derived MSCs

Biological: JOINTSTEM

Jointstem (Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml), 1 time injection

Other Names:

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

Placebo Comparator: Saline solution

Sodium chloride

Drug: Saline solution

Saline solution (Sodium chloride 9mg/ml), 1 time injection

Other Names:

Sodium chloride 9mg/ml

Outcome Measures

Primary Outcome Measures

WOMAC score [24 weeks]
Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)

Secondary Outcome Measures

WOMAC 3 subscale [24 weeks]
Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
KOOS (Knee Injury & Osteoarthritis Outcome Score) [24 weeks]
Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS)
SF(Short Form)-36 Score [24 weeks]
The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.
Global assessment of disease activity [24 weeks]
Change From Baseline in Patient's & Physician's Global Assessment of Disease Activity Score at 12,24 weeks by 100mm VAS(Visual Analogue Scale)
Overall satisfaction [24 weeks]
Patient's overall satisfaction on a 0-100mm VAS(Visual Analogue Scale)
X-ray [24 weeks]
X-ray perform to measure with Kellgren-Lawrence grade
MRI scan [24 weeks]
MRI perform to measure cartilage defect size change from baseline up to 24weeks
Arthroscopy evaluation [24 weeks]
Arthroscopy performs to evaluate any change in cartilage defect at the time of cell injection, and at 24 weeks after injection
Histological evaluation [24 weeks]
Biopsy specimens subject to safranin-O staining and immunohistochemistry for type I and II collagen. Thickness of the articular cartilage before and after injection measure, and specimens evaluate with ICRS(International Cartilage Repair Society) II by a blind histopathologist.
VAS [24 weeks]
Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)
IKDC [24 weeks]
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
ROM [24 weeks]
change from baseline in knee flexion Range of Motion(ROM) at 12,24 weeks by physical examination
Quadriceps power [24 weeks]
Change from baseline in quadriceps power at 12,24 weeks by physical examination
effusion [24 weeks]
Change from baseline in 4-grade knee effusion at 12,24 weeks
Crepitus [24 weeks]
Change from baseline in asymptomatic and symptomatic crepitus at 12,24 weeks by physical examination
Ligament laxity [24 weeks]
Change from baseline in ligament laxity at 12,24 weeks by physical examination
Medial joint line tenderness [24 weeks]
Change from baseline in 4-grade(none, mild, moderate, severe) medial joint line tenderness at 12,24 weeks by physical examination
Pes tenderness [24 weeks]
Change from baseline in 4-grade(none, mild, moderate, severe) Pes tenderness at 12,24 weeks by physical examination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 and older, male and female
Patients must consent in writing to participate in the study by signing and dating an informed consent document
Diagnosis of osteoarthritis by ACR osteoarthritis of the knee
Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
More than Grade 4 (0~10 point numeric scale) pain at least for 12 weeks
Diagnosis of osteoarthritis of class Ⅰ~Ⅲ by ACR(American College of Rheumatology Criteria) Global functional criteria
Patient who agree with contraception

Exclusion Criteria:

Preparing for Pregnancy or Pregnant women or lactating mothers.
Patients with Body Mass Index (BMI) > 35.
Patients with other disease including

: Septic arthritis, Rheumatoid or Inflammatory joint disease, Crystalline disease (gout or pseudogout), Paget disease, Articular fractures, Ochronosis, Acromegaly, Hemochromatosis, Wilson's disease, Osteochondromatosis, Hereditary disorder

Patients with serious condition internal medicine disease
Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening indicative of current of pass infection.
Patient with behavioral disorders, cognitive disorders and chronic mental symptoms
Patient with significant neurologic or psychiatric disorders
Patients who alcohol, drug abuse 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
Patients who the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above
Patients who penicillin hypersensitivity reactions -