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Trial record 24 of 99 for:    stem cell arthritis AND Mesenchymal

A Phase 3 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03990805
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
R-Bio

Brief Summary:
The purpose of this study is to investigate the efficacy and safety of autologous Adipose Tissue derived Mesenchymal stem cells (JOINTSTEM®) in patient with severe Knee Osteoarthritis.

Condition or disease Intervention/treatment Phase
Degenerative Arthritis Knee Osteoarthritis Biological: JOINTSTEM Drug: saline Phase 3

Detailed Description:

JOINTSTEM is injectables for an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is cultured without additional genetic modification, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.

It primarily aims to improve joint function. The intra-articular injection of JOINTSTEM is expected to stimulate the regeneration of cartilage, and to innovatively improve joint function with cartilage regeneration.

The subjects of this therapy were patients with K&L grade 3 aged 20 or older.

This study is a double-blind, randomized, placebo controlled study with two arms to evaluate JOINTSTEM as a treatment for subjects with osteoarthritis. Following a 2-week screening period, approximately 260 patients will be randomly assigned into one of the following two arms in a 1:1 ratio (1 JointStem : 1 placebo control). After each patient completes 6-month visit (Visit 5) and the data management team confirms all data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multi-center, Randomized, Double-Blind, Placebo Controlled Phase 3 Clinical Trial to Evaluate Efficacy and Safty of Mesenchymal Stem Cells JointStem in Patients With Knee Osteoarthritis
Actual Study Start Date : June 11, 2019
Estimated Primary Completion Date : June 3, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: JOINTSTEM
Autologous Adipose Tissue derived MSCs
Biological: JOINTSTEM
JOINTSTEM Autologous Adipose Tissue derived MSCs 1x10^8cells/(saline), 1 time injection
Other Name: Autologous Adipose Tissue derived MSCs

Placebo Comparator: saline
saline
Drug: saline
saline, 1 time injection




Primary Outcome Measures :
  1. Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline [ Time Frame: 12 weeks, 24 weeks ]

    Pain, stiffness, and physical function of the knee will be measured by the WOMAC score

    • Score range is

      1. 0-20 for Pain
      2. 0-8 for Stiffness
      3. 0-68 for Pysical Function
    • Higher scores on the WOMAC indicate wors pain, stiffness, and functional limitations

  2. Change of Visual Analog Scale (VAS) scores from baseline [ Time Frame: 12 weeks, 24 weeks ]

    Pain of knee will be measured by the 100mm VAS

    -Score range is from 0-4mm(no pain) to 75-100mm(severe pain)



Secondary Outcome Measures :
  1. WOMAC 3 subscale score [ Time Frame: 12 weeks, 24 weeks ]
    Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)

  2. VAS score [ Time Frame: 12 weeks, 24 weeks ]
    Pain of knee will be measured by the 100mm Visual Analog Scale (VAS)

  3. KOOS [ Time Frame: 12 weeks, 24 weeks ]

    Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS)

    -Score range is from 0(extreme symptoms) to 100(no symptoms)


  4. SF-36 [ Time Frame: 12 weeks, 24 weeks ]
    The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.

  5. IKDC [ Time Frame: 12weeks, 24 weeks ]
    Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)

  6. Measuring of Kellgren-Lawrence grade [ Time Frame: 12 weeks, 24 weeks ]
    Measuring of Kellgren-Lawrence grade through X-ray

  7. Measuring of Femoro-tibial anatomical angle(FTA) [ Time Frame: 12 weeks, 24 weeks ]
    Measuring of FTA through X-ray

  8. Measuring of Hip-Knee-Ankle angle(HKA) [ Time Frame: 12 weeks, 24 weeks ]
    Measureing of HKA through X-ray

  9. Measuring of Joint Space Width [ Time Frame: 12 weeks, 24 weeks ]
    measuring Joint Space Width through X-ray

  10. MRI scan [ Time Frame: 12 weeks, 24 weeks ]
    MRI perform to measure Modified WORMS (Whole-Organ Magnetic Resonance Imaging Score)

  11. Use of rescue medication [ Time Frame: 12 weeks, 24 weeks ]
    Frequency and total amount of rescue medication administration will be measured.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 20 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 degenerative arthritis of class 1-3 by ACR(American College of Rheumatology Criteria) Global functional criteria
  4. Diagnosis of Kellgren and Lawrence grade 3 by radiographic criteria
  5. Patients suitable for one of three conditions of 'diagnostic criteria for osteoarthritis of knee' based on ACR guideline

    • clinical and inspectional opinion
    • clinical and radiographic opinion
    • clinical opinion
  6. Patients who has joint pain ≥ 50mm on 100mm VAS (Visual Analog Scale) at Screening
  7. Patient who has WOMAC score ≥ 1000 at Screening
  8. No improvement with persisting knee pain at least for 12 weeks (3 months) by nonoperational therapy before Screening

Exclusion Criteria:

  1. Patients who have pregnancy plans within this trial period or childbearing age patients who do not agree to maintain contraception status through appropriate contraception methods

    • Appropriate contraception method: Use of condom, contraceptive sponges, foam, diaphragm, intrauterine device etc.
    • Periodic abstinence(e.g. methods of predicting ovulation) and moderation are not considered as appropriate contraception method.
    • Not allowed to use hormonal contraceptives
    • Childbearing age female patients, exclude menopausal female (amenorrhea for more than 24 months after the last menstruation) or female who has no possibility of pregnency by surgical sterilization operation, can participate in this study only determined negative in pregnancy test
  2. Pregnant women or lactating mothers
  3. Patients with Body Mass Index (BMI) > 35
  4. Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening indicative of current of pass infection
  5. Patients with other disease including

    • Septic arthritis, Rheumatoid or Inflammatory joint disease, Gout, Reccurent pseudogout, Paget disease, Articular fractures, Ochronosis, Acromegaly, Hemochromatosis, Wilson's disease,Osteochondromatosis, Hereditary disorder, Genetic disorder of collagen
  6. Patients who are diagnosed with malignant tumor in the past or present
  7. Patients who have clinically significant diseases including

    • Cardiac disorder (Myocardial infarction, Coronary artery bypass graft, Arrhythmia and other severe Cardiac disorder etc.)
    • Resistant hypertension (systolic blood pressure > 160mmHg or diastolic pressure > 100mmHg at Screening)
    • Kidney disease (Chronic renal failure, Glomerulonephritis etc.)
    • Liver disease (Hepatocirrhosis, Fatty liver, acute or chronic liver disease etc.)
    • Endocrinopathy (Thyroiditis, Diabetes insipidus, Cushing disease etc.)
  8. Patients who have significant lab abnormalities
  9. Patients who have severe pain in other areas that can affect the judgement of knee joint symptom
  10. Patients who underwent any arthroscopic surgery on the injection site within 6 months of the screening visit date, or scheduled to perform any surgery during the clinical trial period
  11. Patients who received any drug by intra-articular injection(hyaluronic acid or steroid etc.) for treatment within 6 months prior to Screening
  12. Patients who experienced as stem cell therapy or blood product injection(PRP, Prolo injection etc.)
  13. Patients who received treatment within 14 days prior to Screening including(But, patients who had wash-out-period can participate in this study)

    • Take medicines including composition of Glucosamine, Chondretin sulphate and Diacerhein etc.
    • Take phytotherapeutic agent or Chinese medicine for osteoarthritis
    • Take antiinflammatory analgesic drug, NSAIDs (prescription/nonprescription pharmaceuticals) etc. (Patients who have 3 days of wash-out-period after they took acetaminophen can participate in the study)
    • Take oral steroids
    • Physical therapy or Chinese medical treatment(cupping, acupuncture, moxibustion etc.)
  14. Patients with penicillin hypersensitivity reactions
  15. Patients with skin diseases or infections in the area of the injection site
  16. Patients who have abnormal flail over grade 2 flail knee test of anterior to posterior and varus/valgus lesion at physical examination
  17. Patients who have difficulty in taking MRI because of metal materials (cardiac pacemaker or clip of cerebral artery etc.) in their body or claustrophobia -but, patients with metal materials that are not affected by magnetic field can participate in this study
  18. Patients who have difficulty in liposuction or local anesthesia
  19. Patients who have alcohol, drug abuse history
  20. Patients who have severe neurologic and psychiatric disorders that affect clinical trials
  21. Patients who had participated in other clinical trials within 12 weeks prior to this study
  22. Patients who the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above

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): NCT03990805


Contacts
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Contact: SEOGJU LEE 82-2-6978-9226 tin50@stemcellbio.com
Contact: YUNHEE BAE yunheebae@kcrnresearch.com

Locations
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Korea, Republic of
Chungbuk National University Hospital Recruiting
Cheongju-si, Korea, Republic of, 28644
Contact: EUISUNG CHOI         
Yeungnam University Hospital Recruiting
Daegu, Korea, Republic of, 42415
Contact: OOGJIN SHON         
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of, 42601
Contact: KICHEOR BAE         
Chonbuk National University Hospital Recruiting
Jeonju, Korea, Republic of, 54907
Contact: JUHONG LEE         
Gyeongsang National University Hospital Recruiting
Jinju-si, Korea, Republic of, 52727
Contact: SUNCHUL HWANG         
Kyunghee University Medical Center Recruiting
Seoul, Korea, Republic of, 02447
Contact: SANGJUN SONG         
Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Contact: KWANKYU PARK         
Soonchunhyang University Hospital Seoul Recruiting
Seoul, Korea, Republic of, 04401
Contact: HYUNGSUK CHOI         
KyungHee University Gangdong Hospital Recruiting
Seoul, Korea, Republic of, 05278
Contact: KangIl Kim, M.D., Ph.D.       kneedr@hotmail.com   
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 06273
Contact: WOOSUK LEE         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: YOUNGWAN MOON         
Chunang University Hospital Recruiting
Seoul, Korea, Republic of, 06973
Contact: HANJUN LEE         
Sponsors and Collaborators
R-Bio
Investigators
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Principal Investigator: KANGIL KIM KyungHee University Gangdong Hospital
Principal Investigator: WOOSUK LEE Gangnam Severance Hospital
Principal Investigator: SUNCHUL HWANG Gyeongsang National University Hospital
Principal Investigator: SANGJUN SONG Kyunghee University Medical Center
Principal Investigator: KICHEOR BAE Keimyung University Dongsan Medical Center
Principal Investigator: YOUNGWAN MOON Samsung Medical Center
Principal Investigator: JUHONG LEE Chonbuk National University Hospital
Principal Investigator: HANJUN LEE Chunang University Hospital
Principal Investigator: EUISUNG CHOI Chungbuk National University Hospital
Principal Investigator: HYUNGSUK CHOI Soonchunhyang University Hospital Seoul
Principal Investigator: KWANKYU PARK Yonsei University
Principal Investigator: OOGJIN SHON Yeungnam University Hospital

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Responsible Party: R-Bio
ClinicalTrials.gov Identifier: NCT03990805     History of Changes
Other Study ID Numbers: BSR-CTph3-JS1
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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