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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658344
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
R-Bio

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : July 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Sodium chloride 9mg/ml


Outcome Measures
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Primary Outcome Measures :
  1. WOMAC score [ Time Frame: 24 weeks ]
    Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)


Secondary Outcome Measures :
  1. WOMAC 3 subscale [ Time Frame: 24 weeks ]
    Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)

  2. KOOS (Knee Injury & Osteoarthritis Outcome Score) [ Time Frame: 24 weeks ]
    Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS)

  3. SF(Short Form)-36 Score [ Time Frame: 24 weeks ]
    The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.

  4. Global assessment of disease activity [ Time Frame: 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)

  5. Overall satisfaction [ Time Frame: 24 weeks ]
    Patient's overall satisfaction on a 0-100mm VAS(Visual Analogue Scale)

  6. X-ray [ Time Frame: 24 weeks ]
    X-ray perform to measure with Kellgren-Lawrence grade

  7. MRI scan [ Time Frame: 24 weeks ]
    MRI perform to measure cartilage defect size change from baseline up to 24weeks

  8. Arthroscopy evaluation [ Time Frame: 24 weeks ]
    Arthroscopy performs to evaluate any change in cartilage defect at the time of cell injection, and at 24 weeks after injection

  9. Histological evaluation [ Time Frame: 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.

  10. VAS [ Time Frame: 24 weeks ]
    Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)

  11. IKDC [ Time Frame: 24 weeks ]
    Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)

  12. ROM [ Time Frame: 24 weeks ]
    change from baseline in knee flexion Range of Motion(ROM) at 12,24 weeks by physical examination

  13. Quadriceps power [ Time Frame: 24 weeks ]
    Change from baseline in quadriceps power at 12,24 weeks by physical examination

  14. effusion [ Time Frame: 24 weeks ]
    Change from baseline in 4-grade knee effusion at 12,24 weeks

  15. Crepitus [ Time Frame: 24 weeks ]
    Change from baseline in asymptomatic and symptomatic crepitus at 12,24 weeks by physical examination

  16. Ligament laxity [ Time Frame: 24 weeks ]
    Change from baseline in ligament laxity at 12,24 weeks by physical examination

  17. Medial joint line tenderness [ Time Frame: 24 weeks ]
    Change from baseline in 4-grade(none, mild, moderate, severe) medial joint line tenderness at 12,24 weeks by physical examination

  18. Pes tenderness [ Time Frame: 24 weeks ]
    Change from baseline in 4-grade(none, mild, moderate, severe) Pes tenderness at 12,24 weeks by physical examination


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658344


Locations
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Korea, Republic of
KyungHee University Gangdong Hospital
Seoul, Korea, Republic of, 134-727
GangNam Severance Hospital
Seoul, Korea, Republic of, 135-720
Sponsors and Collaborators
R-Bio
Investigators
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Principal Investigator: KANGIL KIM, M.D., Ph.D KyungHee University Gangdong Hospital
More Information
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Publications of Results:

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Responsible Party: R-Bio
ClinicalTrials.gov Identifier: NCT02658344    
Other Study ID Numbers: Jointstem2b
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Keywords provided by R-Bio:
Stem cell
adipose tissue derived mesenchymal stem cell
osteoarthritis
 degenerative arthritis
biostar
Rbio
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Osteoarthritis, Knee
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases