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Degenerative ArthritisPhase 2NCT02658344

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

A Phase 2 study testing JOINTSTEM and Saline solution in people with Degenerative Arthritis and Knee Osteoarthritis, run by R-Bio at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Degenerative Arthritis, Knee Osteoarthritis
What is being tested?
JOINTSTEM and Saline solution
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
2 sitesSouth Korea
Study dates
Jul 2015to Dec 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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 -

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • KyungHee University Gangdong Hospital

    Seoul, 134-727

  • GangNam Severance Hospital

    Seoul, 135-720

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
JOINTSTEM, Saline solution
Keywords
Stem cell, adipose tissue derived mesenchymal stem cell, osteoarthritis, degenerative arthritis, biostar, Rbio
Medical subject headings
Osteoarthritis, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JOINTSTEMBiological

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

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

  • Saline solutionDrug

    Also called Sodium chloride 9mg/ml

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

Study groups in NCT02658344
Study groupRoleWhat they receive
JointstemExperimentalAutologous Adipose Tissue derived MSCs
Receives: Biological: JOINTSTEM
Saline solutionPlacebo comparatorSodium chloride
Receives: Drug: Saline solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WOMAC score

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

    Measured: 24 weeks

Secondary outcomes (18)

  1. WOMAC 3 subscale

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

    Measured: 24 weeks

  2. 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)

    Measured: 24 weeks

  3. SF(Short Form)-36 Score

    The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.

    Measured: 24 weeks

  4. 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)

    Measured: 24 weeks

  5. Overall satisfaction

    Patient's overall satisfaction on a 0-100mm VAS(Visual Analogue Scale)

    Measured: 24 weeks

  6. X-ray

    X-ray perform to measure with Kellgren-Lawrence grade

    Measured: 24 weeks

  7. MRI scan

    MRI perform to measure cartilage defect size change from baseline up to 24weeks

    Measured: 24 weeks

  8. Arthroscopy evaluation

    Arthroscopy performs to evaluate any change in cartilage defect at the time of cell injection, and at 24 weeks after injection

    Measured: 24 weeks

  9. 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.

    Measured: 24 weeks

  10. VAS

    Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)

    Measured: 24 weeks

  11. IKDC

    Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)

    Measured: 24 weeks

  12. ROM

    change from baseline in knee flexion Range of Motion(ROM) at 12,24 weeks by physical examination

    Measured: 24 weeks

  13. Quadriceps power

    Change from baseline in quadriceps power at 12,24 weeks by physical examination

    Measured: 24 weeks

  14. effusion

    Change from baseline in 4-grade knee effusion at 12,24 weeks

    Measured: 24 weeks

  15. Crepitus

    Change from baseline in asymptomatic and symptomatic crepitus at 12,24 weeks by physical examination

    Measured: 24 weeks

  16. Ligament laxity

    Change from baseline in ligament laxity at 12,24 weeks by physical examination

    Measured: 24 weeks

  17. 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

    Measured: 24 weeks

  18. Pes tenderness

    Change from baseline in 4-grade(none, mild, moderate, severe) Pes tenderness at 12,24 weeks by physical examination

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2016 (estimated)
  2. Study startJul 2015
  3. Primary completionNov 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02658344
Sponsor's protocol ID
Jointstem2b
Status last verified
Jun 2019
First submitted
3 Aug 2015
Last updated
5 Jun 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30835956

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JOINTSTEM and Saline solution in people with Degenerative Arthritis and Knee Osteoarthritis, run by R-Bio at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WOMAC score (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02658344, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.

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