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Degenerative ArthritisPhase 2NCT02341378

Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis

A Phase 2 study testing TissueGene-C(Low dose) and TissueGene-C(High dose) in people with Degenerative Arthritis, run by Kolon Life Science at 3 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

To assess the efficacy and safety of the intra-articular injection of TissueGene-C in patients with degenerative arthritis of the knee Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Degenerative Arthritis
What is being tested?
TissueGene-C(Low dose) and TissueGene-C(High dose)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
3 sitesSouth Korea
Study dates
Aug 2009to Oct 2010
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 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged 45 years or more
  • With grade 4 degenerative arthritis of the knee [based on the International Cartilage Repair Society(ICRS) evaluation criteria from the MRI results]
  • With less than 6 cm2major lesions
  • With major lesions (grade 4) concentrated in only one section of the knee and considered the main cause of the clinical symptoms
  • Unresponsive to conventional symptomatic treatment
  • Healthy and with no major physical examination, hematology, serum chemistry, and urine test findings 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

  • Abnormal screening laboratory test (hematology, serum, and urine test) findings
  • Took anti-inflammatory medications (prescribed or over-the-counter), including natural medicines, within 14 days before the injection of the investigational product
  • Took antirheumatic drugs (e.g., methotrexate or antimetabolites) within three months before enrollment in this study
  • Has a history of drug abuse within one year from the enrolment, or has positive results in the urine drug test or serum alcohol test at the screening visit
  • Received an injection in the target knee within two months before enrollment in this study
  • Pregnant or breastfeeding female
Show all 20Show fewer
  • 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, and synovial chondromas)
  • With a current infectious disease, including HIV or hepatitis
  • Has any of the following clinically significant diseases:
  • heart disease [e.g., myocardial infarction, arrhythmia, other serious heart disease, coronary artery bypass graft (CABG)]
  • 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 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
  • Considered by the investigator inappropriate for participation in this study

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Samsung Medical Center

    Gangnam-gu, Seoul, 135-710

  • Seoul National Univ. Hospital

    Seoul, 110-744

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

About this study

Official title: A Multicenter, Single-blind, Phase 2A Clinical Trial to Evaluate the Efficacy and Safety of TissueGene-C, a Cell-mediated Gene Therapy, in Degenerative Arthritis Patients

To assess the efficacy and safety of the intra-articular injection of TissueGene-C in patients with degenerative arthritis of the knee

Read the detailed description

TissueGene-C is a biological new drug which consists of non-transduced chondrocytes and transduced chondrocytes that express Transforming Growth Factor(TGF)-b1 to regenerate the damaged cartilage.

During the clinical trial Phase 2A, we compare low dose or high dose TissueGene-C in 6 months trial with 28 outpatients who have degenerative arthritis. The patients are randomized to two dose levels of TisssueGene-C by 1:1 ratio, and they are monitored and recorded for alleviating symptoms, sports activities, function of the knee, and the presence of adverse events.

Being tested
TissueGene-C(Low dose), TissueGene-C(High dose)
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-C(Low dose)Biological

    TissueGene-C at 6.0x10^6 cells

  • TissueGene-C(High dose)Biological

    TissueGene-C at 1.8x10^7 cells

Study groups in NCT02341378
Study groupRoleWhat they receive
TissueGene-C (Low dose)ExperimentalSingle intra-articular injection to the damaged knee joint at a dose of 6.0 x 10^6 cells
Receives: Biological: TissueGene-C(Low dose)
TissueGene-C (High dose)ExperimentalSingle intra-articular injection to the damaged knee joint at a dose of 1.8 x 10^7 cells
Receives: Biological: TissueGene-C(High dose)

What is being measured

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

  1. Changes in IKDC Subjective Knee Evaluation

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

    Measured: Week 0, 12 and 24

Secondary outcomes (5)

  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: Week 0, 12 and 24

  2. Changes in 100 mm-VAS

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

    Measured: Week 0, 12 and 24

  3. Comparative Evaluation of Knee MRI

    Change in the Magnetic Resonance Images (MRI) scan results after the administration of TissueGene-C

    Measured: Week 0, 12 and 24

  4. Number of Participants with Adverse Events

    Allergic reaction, Injection site reaction , Infection in the injection site, Fibrosis, Fibrosis-deep connective tissue, Muscular/skeletal hypoplasia, TGF-β1 Enzyme-linked Immunosorbent Assay (ELISA) result, Polymerase Chain Reaction(PCR) for the vector DNA test results

    Measured: Week 0, 2, 4, 12 and 24

  5. Evaluation of Physical examination and laboratory tests

    Vital signs, Physical examination findings, Monitoring of the hematology, serum chemistry, and urine test results

    Measured: Week 0, 2, 4, 12 and 24

Timeline

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

  1. First posted19 Jan 2015 (estimated)
  2. Study startAug 2009
  3. Primary completionJun 2010
  4. Study completionOct 2010

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
Single blind
Who is masked
Participant
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02341378
Sponsor's protocol ID
TCG-K1-02
Status last verified
Jan 2015
First submitted
8 Jan 2015
Last updated
22 Jan 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Ha CW, Cho JJ, Elmallah RK, Cherian JJ, Kim TW, Lee MC, Mont MA. A Multicenter, Single-Blind, Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of a Cell-Mediated Gene Therapy in Degenerative Knee Arthritis Patients. Hum Gene Ther Clin Dev. 2015 Jun;26(2):125-30. doi: 10.1089/humc.2014.145. Epub 2015 Apr 17.

    PubMed 25760423

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TissueGene-C(Low dose) and TissueGene-C(High dose) in people with Degenerative Arthritis, run by Kolon Life Science at 3 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 8 inclusion and 20 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 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. 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?

Changes in IKDC Subjective Knee Evaluation (time frame: Week 0, 12 and 24). 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 NCT02341378, 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 22 Jan 2015.

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