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Degenerative ArthritisPhase 3NCT02072070

Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis

A Phase 3 study testing TissueGene-C in people with Degenerative Arthritis, run by Kolon Life Science at 12 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 determine whether TissueGene-C, an allogeneic human chondrocytes expressing Transforming Growth Factor(TGF)-b1, is effective and safe in patients with degenerative arthritis. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Degenerative Arthritis
What is being tested?
TissueGene-C
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
163 participants
Where
12 sitesSouth Korea
Study dates
Nov 2013to Aug 2015
Phase
Phase 3
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients at least 19 years of age
  • Patients diagnosed with degenerative arthritis
  • Patients with IKDC(Knee Documentation Committee subjective score) score of 60 or below
  • Patients with 100 mm VAS(Visual Analog Scale) score of 40 or above
  • With Grade 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
  • With an International Cartilage Repair Society(ICRS) Grade III or IV cartilage damage in the major lesions, as confirmed through an MRI scan
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  • With a Body Mass Index(BMI) of higher than18.5 and lower than 30
  • Patients who satisfies the clinical/radiational criteria by the American College of Rheumatology (ACR) guidelines, and applies to one of the following.
  • Older than 50
  • Morning stiffness for less than 30 minutes
  • Crepitus and Osteophytes
  • With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms
  • With no alleviation of the symptoms even after at least three months of non-surgical treatment
  • Healthy, with no major findings from the physical examination, hematology, serum chemistry, and urine tests, and no significant medical history
  • Agreed to use an effective contraceptive method during the study period
  • Voluntarily agreed to participate in this study, and signed the informed consent form

Who cannot join

  • Showed clinically significant hematology, serum chemistry, and urine test results at the screening visit
  • Regarding inclusion criteria 6. following patients should not be included
  • patients with a major lesion of ICRS grade 4 which is larger than 6cm2(for patient with ICRS grade 4)
  • patients with a major lesion of ICRS grade 3 which is larger than 6cm2(for patient without a ICRS grade 4),
  • Patient who had skin disease around target knee
  • patients who have a positive skin reaction to CS-10
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  • Patients who had been administered with drugs such as oriental medicine, glucosamine and chondroitin within 14 days of baseline visit
  • Patients taking steroidal anti-inflammatory medications within 14 days of baseline visit
  • Patients with severe pain in other areas that could effect the diagnosis of the symptoms of the
  • History of surgery like arthroendoscopy within the past 6 months on the target knee
  • Patients who had been administered with immunosuppressants, including antirheumatic drugs (including methotrexate or antimetabolite), within the past 3 months
  • Patients who had been treated with physical therapy or herbal remedy (acupuncture, heat etc.) within 2 weeks of baseline visit
  • History of injection within the past 3 months on the target knee
  • Pregnant or breastfeeding female
  • With another joint disease apart from degenerative arthritis (e.g., systemic rheumatic inflammatory disease associated with the knee or chondrocalcinosis, hemachromatosis, inflammatory arthritis, necrosis of the trochanter, Paget's disease adjacent to a joint in the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's disease in the knee joint, villonodular synovitis, synovial chondromas)
  • With an infectious disease, including HIV or hepatitis
  • With any of the following clinically significant diseases:
  • heart disease (e.g., myocardial infarction, arrhythmia, other serious heart diseases, coronary artery bypass graft)
  • kidney disease (e.g., chronic renal failure, glomerulonephritis)
  • liver disease (e.g., liver cirrhosis, fatty liver, acute or chronic liver disease)
  • endocrine disease (e.g., hyperthyroidism, hypothyroidism, thyroiditis, diabetes insipidus, Cushing's disease)
  • insulin-dependent diabetes mellitus
  • medical history of past or current malignant tumor
  • In particular, the tumors that TissueGene-C may aggravate can be screened using the following tests:
  • Leukemia (White Blood Cell level in the hematology)
  • Osteochondroma, Chondromas, Chondroblastoma, Chondromyxoid fibroma, Chondrosarcoma (Alkaline phosphatase level in the hematology)
  • Participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study
  • Patients who administered the TissueGene-C from past clinical trial
  • Considered inappropriate by the investigator for participation in this study

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

South Korea12 sites

  • Chungbuk National University Hospital

    Cheongju-si, 361-711

  • Kyungpook National Univ. Hospital

    Daegu, 700-721

  • Inha University Hospital

    Incheon, 400-711

  • Chonbuk National University Hospital

    Jeonju, 561-712

  • Inje University Seoul Paik Hospital

    Seoul, 100-032

  • Seoul National University Hospital

    Seoul, 110-744

  • Hanyang University Medical Center

    Seoul, 133-791

  • Samsung Medical Center

    Seoul, 135-710

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul, 137-701

  • ASAN Medical Center

    Seoul, 138-736

  • Ewha Womans University Mokdong Hospital

    Seoul, 158-710

  • Ulsan University Hospital

    Ulsan, 682-714

Other trials in South Korea

About this study

Official title: A Placebo Controlled, Double-blind, Randomized, Parallel-group, Multi-center Phase III Study to Determine the Efficacy and Safety of TissueGene-C in Patients With Degenerative Arthritis

The purpose of this study is to determine whether TissueGene-C, an allogeneic human chondrocytes expressing Transforming Growth Factor(TGF)-b1, is effective and safe in patients with degenerative arthritis.

Read the detailed description

TissueGene-C is a biological new drug which consists of normal chondrocyte cells and transduced chondrocyte cells that express growth factor to modify osteoarthritis symptom for long term period.

During the Phase 3 clinical trial , we will compare TissueGene-C to placebo in 26, 52 weeks trial with 156 outpatients who have osteoarthritis. The outpatients are randomized to TissueGene-C or placebo in 1:1 ratio, and they will be monitored and recorded in terms of alleviating symptoms, sports activities, function of the knee, and the presence of adverse events.

Being tested
TissueGene-C, Placebo
Keywords
chondrocyte cells, Osteoarthritis, gene therapy
Medical subject headings
Osteoarthritis

What participants receive

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

  • TissueGene-CBiological

    TissueGene-C at 1.8 x 10^7 cells

  • PlaceboDrug

    Placebo control(Normal Saline)

Study groups in NCT02072070
Study groupRoleWhat they receive
TissueGene-CExperimentalSingle intra-articular injection to the damaged knee joint at a dose of 1.8 x 10^7 cells
Receives: Biological: TissueGene-C
PlaceboPlacebo comparatorSingle intra-articular injection to the damaged knee joint
Receives: Drug: Placebo

What is being measured

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

  1. Changes in IKDC scores

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

    Measured: Week 0 and 52

  2. Changes in 100 mm VAS scores

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

    Measured: Week 0 and 52

Secondary outcomes (8)

  1. Changes in WOMAC scores

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

    Measured: Wekk 0, 26, 39 and 52

  2. Changes in KOOS scores

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

    Measured: Week 0, 26, 39 and 52

  3. Changes in MRI scan

    Comparison of pre-procedure MRI scans to those obtained at pre-dosing and at months 6 and 12 following dosing by an independent radiographic reviewer.

    Measured: Week 0, 26 and 52

  4. Changes in Joint Space Width by an independent radiographic reviewer.

    Measured: Week 0, 26 and 52

  5. Level of Biomarkers in blood and urine.

    Measured: Week 0, 26, 39 and 52

  6. Proportion of Patients Use of Rescue Medication.

    Measured: Week 4, 12, 26, 39 and 52

  7. Changes in IKDC scores

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

    Measured: Week 0, 26 and 39

  8. Changes in 100 mm VAS scores

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

    Measured: Week 0, 26 and 39

Timeline

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

  1. First posted26 Feb 2014 (estimated)
  2. Study startNov 2013
  3. Primary completionAug 2015
  4. Study completionAug 2015

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02072070
Sponsor's protocol ID
KS-TGC-01-3
Status last verified
Nov 2017
First submitted
17 Feb 2014
Last updated
17 Nov 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Chen L, Huang FL, Tang Q, Zhao ZK, Ye ZY, Liang JH. Targeted therapy for knee osteoarthritis: From basic to clinics. Medicine (Baltimore). 2025 Aug 15;104(33):e43686. doi: 10.1097/MD.0000000000043686.

    PubMed 40826764

  • Kim MK, Ha CW, In Y, Cho SD, Choi ES, Ha JK, Lee JH, Yoo JD, Bin SI, Choi CH, Kyung HS, Lee MC. A Multicenter, Double-Blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of a Cell and Gene Therapy in Knee Osteoarthritis Patients. Hum Gene Ther Clin Dev. 2018 Mar;29(1):48-59. doi: 10.1089/humc.2017.249.

    PubMed 29641281

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TissueGene-C in people with Degenerative Arthritis, run by Kolon Life Science at 12 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 16 inclusion and 29 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Changes in IKDC scores (time frame: Week 0 and 52). The study lists 2 primary outcomes in all. 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 NCT02072070, which also lists 2 linked publications.

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 17 Nov 2017.

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