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

Phase 2

Completed

• Conditions: Degenerative Arthritis; Knee Osteoarthritis
• Interventions: Biological: JOINTSTEM; Drug: Saline solution

• Registration Number: NCT02658344
• Lead Sponsor: R-Bio

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.

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-18
• Primary Completion: 2016-11
• Study Completion: 2016-12
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-03
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

1. Preparing for Pregnancy or Pregnant women or lactating mothers.

2. Patients with Body Mass Index (BMI) > 35.

3. 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

4. Patients with serious condition internal medicine disease

5. Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening indicative of current of pass infection.

6. Patient with behavioral disorders, cognitive disorders and chronic mental symptoms

7. Patient with significant neurologic or psychiatric disorders

8. Patients who alcohol, drug abuse history

9. Patients who had participated in other clinical trials within 12 weeks prior to this study.

10. Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment.

11. Patients who experienced as the knee joint cartilage and stem cell therapy

12. Patients who the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above

13. Patients who penicillin hypersensitivity reactions -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jointstem	JOINTSTEM	Autologous Adipose Tissue derived MSCs
Saline solution	Saline solution	Sodium chloride

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
ROM	24 weeks	change from baseline in knee flexion Range of Motion(ROM) at 12,24 weeks by physical examination
SF(Short Form)-36 Score	24 weeks	The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.
Overall satisfaction	24 weeks	Patient's overall satisfaction on a 0-100mm VAS(Visual Analogue Scale)
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)
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
WOMAC 3 subscale	24 weeks	Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
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)
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)
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
Ligament laxity	24 weeks	Change from baseline in ligament laxity at 12,24 weeks by physical examination
Crepitus	24 weeks	Change from baseline in asymptomatic and symptomatic crepitus 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

Trial Locations

Locations (2)

GangNam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

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