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Safety and Biological Efficacy Study of TisssueGene-C to Degenerative Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02341391
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : July 5, 2018
Sponsor:
Information provided by (Responsible Party):
Kolon Life Science

Brief Summary:

The primary purpose of the this study is to evaluate the safety of TissueGene-C, a gene therapy product that uses allogenic human chondrocytes expressing Transforming Growth Factor(TGF)-β1 by assessing the inflammation at the injection site, the incidence and severity of the adverse events, the physical examination findings, and the laboratory test results after the intra-articular injection of TissueGene-C.

And Secondary purpose is to evaluate the biological efficacy (knee pain, range of motion, functional tests, and MRI) of TissueGene-C and the distribution of TissueGene-C outside the injection site.


Condition or disease Intervention/treatment Phase
Degenerative Arthritis Biological: TissueGene-C(Low dose) Biological: TissueGene-C(Medium dose) Biological: TissueGene-C(High dose) Phase 1

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 clinical trial Phase 1, we compare three different dose levels of TisssueGene-C in 6 months with 12 outpatients with degenerative arthritis. The patients are randomized by three different dose levels of TisssueGene-C in 1:1:1 ratio, and they are monitored and recorded for alleviating symptoms, sports activities, function of the knee, and the presence of adverse events.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Dose-escalating, Single-center, Phase I Clinical Trial to Investigate the Safety and Biological Efficacy of TissueGene-C in Degenerative Arthritis Patients.
Study Start Date : February 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : September 2008

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 doses of 3.0 x 10^6 cells
Biological: TissueGene-C(Low dose)
3.0 x 10^6 cells

Experimental: TissueGene-C(Medium dose)
Single intra-articular injection to the damaged knee joint at doses of 1.0 x 10^7 cells
Biological: TissueGene-C(Medium dose)
1.0 x 10^7 cells

Experimental: TissueGene-C(High dose)
Single intra-articular injection to the damaged knee joint at doses of 3.0 x 10^7 cells
Biological: TissueGene-C(High dose)
3.0 x 10^7 cells




Primary Outcome Measures :
  1. Number of Participants with Adverse Events after the administration of TissueGene-C [ Time Frame: 6 months ]
    Number of Participants with Adverse Events after the administration of TissueGene-C


Secondary Outcome Measures :
  1. Changes in MRI scan [ Time Frame: before and 28 days, 3 months, and 6 months ]
    Change in the MRI scan results after the administration of TissueGene-C

  2. Change in the Knee Society Clinical Rating System(KSCRS) test results [ Time Frame: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months ]
    Comparative Evaluation of knee exam

  3. Changes in WOMAC scores [ Time Frame: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months ]
    Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities(WOMAC)

  4. Changes in 100 mm-VAS [ Time Frame: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months ]
    Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)

  5. Analysis of the TGF-β1 expression using Enzyme-linked Immunosorbent Assay(ELISA) and Polymerase Chain Reaction(PCR) [ Time Frame: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months ]
    Analysis of the TGF-β1 expression using Enzyme-linked Immunosorbent Assay(ELISA) and Polymerase Chain Reaction(PCR)

  6. Replication-competent retrovirus test (RCR test) [ Time Frame: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months ]
    Replication-competent retrovirus test (RCR test)



Information from the National Library of Medicine

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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 patients
  2. Patients aged 45 years or more with Grade IV [based on the International Cartilage Repair Society(ICRS) evaluation criteria from the MRI scan results] degenerative arthritis of the knee, whose symptoms had not been relieved by the conventional symptomatic treatment
  3. Healthy, with no major physical examination, hematology, serum chemistry, and urine test findings and no significant medical history
  4. Patients with cartilage damage sized 2-6 cm2 (based on the ICRS evaluation criteria from the MRI scan results)
  5. Voluntarily agreed to participate in this study and signed the informed consent form

Exclusion Criteria:

  1. Showed clinically significant hematology, serum chemistry, or urine test results at the screening visit
  2. Took an anti-inflammatory medication (prescribed or over-the-counter), including natural medicine, within 14 days from the administration of the investigational product
  3. Has a history of drug abuse within one year from the enrollment, or the urine test or blood alcohol test result was positive at the screening visit
  4. Received any injection in the target knee within two months before the initiation of the study
  5. Pregnant or breastfeeding female
  6. 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 the tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's disease in the knee joint, villonodular synovitis, and synovial chondromas)
  7. With an infectious disease, including HIV or hepatitis (HBV/HCV)
  8. With a history 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
  9. Participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study
  10. Showed positive drug test results at the screening visit
  11. Did not agree to use a contraceptive method (male and female)

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): NCT02341391


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Kolon Life Science
Investigators
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Principal Investigator: Chul Won Ha, MD, PhD Samsung Medical Center
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Responsible Party: Kolon Life Science
ClinicalTrials.gov Identifier: NCT02341391    
Other Study ID Numbers: TGC-KI-01
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: July 5, 2018
Last Verified: July 2018
Keywords provided by Kolon Life Science:
chondrocyte cells
Osteoarthritis
gene therapy
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases