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Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kolon Life Science
ClinicalTrials.gov Identifier:
NCT01671072
First received: August 20, 2012
Last updated: January 21, 2015
Last verified: January 2015
  Purpose

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


Condition Intervention Phase
Degenerative Arthritis
Biological: TissueGene-C
Drug: Normal Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Placebo Controlled, Single-blind, Randomized, Multi-center Phase 2B Study to Determine the Efficacy and Safety of TissueGene-C, an Allogeneic Human Chondrocytes Expressing TGF-b1, in Patients With Degenerative Arthritis

Resource links provided by NLM:


Further study details as provided by Kolon Life Science:

Primary Outcome Measures:
  • Changes in IKDC Subjective Score. [ Time Frame: Week 0 and 24 ] [ Designated as safety issue: No ]
    Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)


Secondary Outcome Measures:
  • Changes in WOMAC scores. [ Time Frame: Week 0 and 24 ] [ Designated as safety issue: No ]
    Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)

  • Changes in KOOS scores. [ Time Frame: Week 0 and 24 ] [ Designated as safety issue: No ]
    Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS)

  • Changes in 100 mm-VAS. [ Time Frame: Week 0 and 24 ] [ Designated as safety issue: No ]
    Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)

  • MRI scan [ Time Frame: Week 0 and 24 ] [ Designated as safety issue: Yes ]
    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.

  • Proportion of Patients Use of Rescue Medication [ Time Frame: Week 4, 12 and 24 ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: July 2011
Study Completion Date: January 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TissueGene-C
Single intra-articular injection to the damaged knee joint a dose of 1.8 x 10^7 cells
Biological: TissueGene-C
TissueGene-C at 1.8 x 10^7 cells
Placebo Comparator: Normal Saline
Single intra-articular injection to the damaged knee joint at the same volume
Drug: Normal Saline
Sodium chloride 0.9%, 3.5ml

Detailed Description:

TissueGene-C is a biological new drug which consists of normal chondrocytes and transduced chondrocytes that express growth factors to regenerate the damaged cartilage tissues.

In the clinical trial Phase 2b, the investigators compared TissueGene-C to placebo during 6 - months trial with 54 outpatients who have had degenerative arthritis. The outpatients are assigned to TissueGene-C or placebo in 1:1 ratio, and will be monitored and recorded for improving clinical symptoms, sports activities, and function of the knee, and for the presence of adverse events.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female or male aged 18 years or more
  2. Diagnosed with degenerative arthritis of the knee
  3. With an IKDC score of 60 or lower at the screening visit
  4. With Grade 2 or 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
  5. With a Body Mass Index(BMI) of higher than18.5 and lower than 30
  6. With an International Cartilage Repair Society(ICRS) Grade IV cartilage damage in the major lesions, as confirmed through an MRI scan
  7. With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms
  8. With no alleviation of the symptoms even after at least three months of non-surgical treatment
  9. Healthy, with no major findings from the physical examination, hematology, serum chemistry, and urine tests, and no significant medical history
  10. Agreed to use an effective contraceptive method during the study period
  11. Voluntarily agreed to participate in this study, and signed the informed consent form

Exclusion Criteria:

  1. Showed clinically significant hematology, serum chemistry, and urine test results at the screening visit
  2. Falls under Inclusion Criteria 6 but with the damage in the relevant lesion considered ICRS Grade IV sized more than 6 cm2
  3. Took glucosamine, chondroitin, or any natural medicine within 14 days before the injection of the investigational product (but if the 14-day washout period had elapsed, the patient can be enrolled in this study)
  4. Has taken anti-inflammatory drugs (prescribed or over-the-counter) within 14 days before the injection of the investigational product (but if the 14-day washout period had elapsed, the patient can be enrolled in this study)
  5. Has taken immunosuppressive agents, including antirheumatic drugs (e.g., methotrexate or antimetabolites) within 3 months before enrollment in this study
  6. With a history of drug abuse within one year prior to enrollment in this study, or showed positive results in the urine drug test or the serum alcohol test at the screening visit
  7. Received an injection in the target knee within two months before enrollment in this study
  8. Pregnant or breastfeeding female
  9. 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)
  10. With an infectious disease, including HIV or hepatitis
  11. With any of the following clinically significant diseases:

    • heart disease [e.g., myocardial infarction, arrhythmia, other serious heart diseases, 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 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)
  12. Participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study
  13. Considered inappropriate by the investigator for participation in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671072

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

No publications provided

Responsible Party: Kolon Life Science
ClinicalTrials.gov Identifier: NCT01671072     History of Changes
Other Study ID Numbers: KS-TGC-01-2B
Study First Received: August 20, 2012
Last Updated: January 21, 2015
Health Authority: Korea: Food and Drug Administration

Keywords provided by Kolon Life Science:
Chondrocyte cells
Osteoarthritis
Gene therapy

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

ClinicalTrials.gov processed this record on February 26, 2015