Back to resultsClinical Trial to Evaluate Efficacy and Safety of JOINTSTEM in Patients With Degenerative Arthritis
Primary Purpose
Degenerative Arthritis, Knee Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
JOINTSTEM
Saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Arthritis focused on measuring Stem cell, adipose tissue derived mesenchymal stem cell, osteoarthritis, degenerative arthritis, biostar, Rbio
Eligibility Criteria
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 -
Sites / Locations
- KyungHee University Gangdong Hospital
- GangNam Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Jointstem
Saline solution
Arm Description
Autologous Adipose Tissue derived MSCs
Sodium chloride
Outcomes
Primary Outcome Measures
WOMAC score
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
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)
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
The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.
Global assessment of disease activity
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
Patient's overall satisfaction on a 0-100mm VAS(Visual Analogue Scale)
X-ray
X-ray perform to measure with Kellgren-Lawrence grade
MRI scan
MRI perform to measure cartilage defect size change from baseline up to 24weeks
Arthroscopy evaluation
Arthroscopy performs to evaluate any change in cartilage defect at the time of cell injection, and at 24 weeks after injection
Histological evaluation
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
Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)
IKDC
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
ROM
change from baseline in knee flexion Range of Motion(ROM) at 12,24 weeks by physical examination
Quadriceps power
Change from baseline in quadriceps power at 12,24 weeks by physical examination
effusion
Change from baseline in 4-grade knee effusion at 12,24 weeks
Crepitus
Change from baseline in asymptomatic and symptomatic crepitus at 12,24 weeks by physical examination
Ligament laxity
Change from baseline in ligament laxity at 12,24 weeks by physical examination
Medial joint line tenderness
Change from baseline in 4-grade(none, mild, moderate, severe) medial joint line tenderness at 12,24 weeks by physical examination
Pes tenderness
Change from baseline in 4-grade(none, mild, moderate, severe) Pes tenderness at 12,24 weeks by physical examination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02658344
Brief Title
Clinical Trial to Evaluate Efficacy and Safety of JOINTSTEM in Patients With Degenerative Arthritis
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 Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
R-Bio
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Arthritis, Knee Osteoarthritis
Keywords
Stem cell, adipose tissue derived mesenchymal stem cell, osteoarthritis, degenerative arthritis, biostar, Rbio
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Jointstem
Arm Type
Experimental
Arm Description
Autologous Adipose Tissue derived MSCs
Arm Title
Saline solution
Arm Type
Placebo Comparator
Arm Description
Sodium chloride
Intervention Type
Biological
Intervention Name(s)
JOINTSTEM
Other Intervention Name(s)
Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml
Intervention Description
Jointstem (Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml), 1 time injection
Intervention Type
Drug
Intervention Name(s)
Saline solution
Other Intervention Name(s)
Sodium chloride 9mg/ml
Intervention Description
Saline solution (Sodium chloride 9mg/ml), 1 time injection
Primary Outcome Measure Information:
Title
WOMAC score
Description
Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
WOMAC 3 subscale
Description
Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
Time Frame
24 weeks
Title
KOOS (Knee Injury & Osteoarthritis Outcome Score)
Description
Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame
24 weeks
Title
SF(Short Form)-36 Score
Description
The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.
Time Frame
24 weeks
Title
Global assessment of disease activity
Description
Change From Baseline in Patient's & Physician's Global Assessment of Disease Activity Score at 12,24 weeks by 100mm VAS(Visual Analogue Scale)
Time Frame
24 weeks
Title
Overall satisfaction
Description
Patient's overall satisfaction on a 0-100mm VAS(Visual Analogue Scale)
Time Frame
24 weeks
Title
X-ray
Description
X-ray perform to measure with Kellgren-Lawrence grade
Time Frame
24 weeks
Title
MRI scan
Description
MRI perform to measure cartilage defect size change from baseline up to 24weeks
Time Frame
24 weeks
Title
Arthroscopy evaluation
Description
Arthroscopy performs to evaluate any change in cartilage defect at the time of cell injection, and at 24 weeks after injection
Time Frame
24 weeks
Title
Histological evaluation
Description
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.
Time Frame
24 weeks
Title
VAS
Description
Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)
Time Frame
24 weeks
Title
IKDC
Description
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
Time Frame
24 weeks
Title
ROM
Description
change from baseline in knee flexion Range of Motion(ROM) at 12,24 weeks by physical examination
Time Frame
24 weeks
Title
Quadriceps power
Description
Change from baseline in quadriceps power at 12,24 weeks by physical examination
Time Frame
24 weeks
Title
effusion
Description
Change from baseline in 4-grade knee effusion at 12,24 weeks
Time Frame
24 weeks
Title
Crepitus
Description
Change from baseline in asymptomatic and symptomatic crepitus at 12,24 weeks by physical examination
Time Frame
24 weeks
Title
Ligament laxity
Description
Change from baseline in ligament laxity at 12,24 weeks by physical examination
Time Frame
24 weeks
Title
Medial joint line tenderness
Description
Change from baseline in 4-grade(none, mild, moderate, severe) medial joint line tenderness at 12,24 weeks by physical examination
Time Frame
24 weeks
Title
Pes tenderness
Description
Change from baseline in 4-grade(none, mild, moderate, severe) Pes tenderness at 12,24 weeks by physical examination
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KANGIL KIM, M.D., Ph.D
Organizational Affiliation
KyungHee University Gangdong Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KyungHee University Gangdong Hospital
City
Seoul
ZIP/Postal Code
134-727
Country
Korea, Republic of
Facility Name
GangNam Severance Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
30835956
Citation
Lee WS, Kim HJ, Kim KI, Kim GB, Jin W. Intra-Articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Phase IIb, Randomized, Placebo-Controlled Clinical Trial. Stem Cells Transl Med. 2019 Jun;8(6):504-511. doi: 10.1002/sctm.18-0122. Epub 2019 Mar 5.
Results Reference
result
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Clinical Trial to Evaluate Efficacy and Safety of JOINTSTEM in Patients With Degenerative Arthritis
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