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Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis

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ClinicalTrials.gov Identifier: NCT02341378
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):
Kolon Life Science

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

Condition or disease Intervention/treatment Phase
Degenerative Arthritis Biological: TissueGene-C(Low dose) Biological: TissueGene-C(High dose) Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : August 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TissueGene-C (Low dose)
Single intra-articular injection to the damaged knee joint at a dose of 6.0 x 10^6 cells
Biological: TissueGene-C(Low dose)
TissueGene-C at 6.0x10^6 cells

Experimental: TissueGene-C (High dose)
Single intra-articular injection to the damaged knee joint at a dose of 1.8 x 10^7 cells
Biological: TissueGene-C(High dose)
TissueGene-C at 1.8x10^7 cells




Primary Outcome Measures :
  1. Changes in IKDC Subjective Knee Evaluation [ Time Frame: Week 0, 12 and 24 ]
    Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)


Secondary Outcome Measures :
  1. Changes in WOMAC scores [ Time Frame: Week 0, 12 and 24 ]
    Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities(WOMAC)

  2. Changes in 100 mm-VAS [ Time Frame: Week 0, 12 and 24 ]
    Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)

  3. Comparative Evaluation of Knee MRI [ Time Frame: Week 0, 12 and 24 ]
    Change in the Magnetic Resonance Images (MRI) scan results after the administration of TissueGene-C

  4. Number of Participants with Adverse Events [ Time Frame: Week 0, 2, 4, 12 and 24 ]
    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

  5. Evaluation of Physical examination and laboratory tests [ Time Frame: Week 0, 2, 4, 12 and 24 ]
    Vital signs, Physical examination findings, Monitoring of the hematology, serum chemistry, and urine test results



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, aged 45 years or more
  2. With grade 4 degenerative arthritis of the knee [based on the International Cartilage Repair Society(ICRS) evaluation criteria from the MRI results]
  3. With less than 6 cm2major lesions
  4. With major lesions (grade 4) concentrated in only one section of the knee and considered the main cause of the clinical symptoms
  5. Unresponsive to conventional symptomatic treatment
  6. Healthy and with no major physical examination, hematology, serum chemistry, and urine test findings and no significant medical history
  7. Agreed to use an effective contraceptive method during the study period
  8. Voluntarily agreed to participate in this study and signed the Informed Consent Form

Exclusion Criteria:

  1. Abnormal screening laboratory test (hematology, serum, and urine test) findings
  2. Took anti-inflammatory medications (prescribed or over-the-counter), including natural medicines, within 14 days before the injection of the investigational product
  3. Took antirheumatic drugs (e.g., methotrexate or antimetabolites) within three months before enrollment in this study
  4. 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
  5. Received an injection in the target knee within two months before enrollment in this study
  6. Pregnant or breastfeeding female
  7. 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)
  8. With a current infectious disease, including HIV or hepatitis
  9. 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
  10. Participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study
  11. Considered by the investigator inappropriate for participation in this study

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): NCT02341378


Locations
Korea, Republic of
Samsung Medical Center
Gangnam-gu, Seoul, Korea, Republic of, 135-710
Seoul National Univ. Hospital
Seoul, Korea, Republic of, 110-744
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Kolon Life Science
Investigators
Principal Investigator: Chul-won Ha, MD, PhD Samsung Medical Center
Principal Investigator: Myung-chul Lee, MD, PhD Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kolon Life Science
ClinicalTrials.gov Identifier: NCT02341378     History of Changes
Other Study ID Numbers: TCG-K1-02
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015

Keywords provided by Kolon Life Science:
chondrocyte cells
Osteoarthritis
gene therapy

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases