Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis

January 21, 2015 updated by: Kolon Life Science

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National Univ. Hospital
    • Seoul
      • Gangnam-gu, Seoul, Korea, Republic of, 135-710
        • Samsung medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Week 0, 12 and 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Week 0, 12 and 24
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)
Week 0, 12 and 24
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
Week 0, 12 and 24
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
Week 0, 2, 4, 12 and 24
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
Week 0, 2, 4, 12 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

January 8, 2015

First Submitted That Met QC Criteria

January 13, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Estimate)

January 22, 2015

Last Update Submitted That Met QC Criteria

January 21, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCG-K1-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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