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: February 17, 2014
Last verified: March 2013
  Purpose

The purpose of this study is to determine whether TissueGene-C, an allogeneic human chondrocytes expressing TGF-b1, is effective and safe in patients with degenerative arthritis.


Condition Intervention Phase
Degenerative Arthritis
Biological: TisssueGene-C
Drug: Placebo
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 IIb 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, 4, 12, 24 and 48 ] [ 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, 4, 12, 24 and 48 ] [ 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, 4, 12, 24 and 48 ] [ 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, 4, 12, 24 and 48 ] [ 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, 24 and 48 ] [ 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.


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: TisssueGene-C
Single intra-articular injection to the damaged knee joint a dose of 1.8 x 10^7 cells
Biological: TisssueGene-C
Tissuege-C at 1.8 x 10^7 cells
Placebo Comparator: Placebo
Single intra-articular injection to the damaged knee joint at the same volume
Drug: Placebo
Placebo control(Normal Saline)

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:

  • Male or female patients at least 18 years of age
  • Patients with IKDC score of 60 or below
  • Body Mass Index (BMI) between '18.5 - 30.0.'
  • Clinical diagnosis of degenerative arthritis
  • Kellgren & Lawrence Grade 2 or 3
  • ICRS of grade IV, defect < 6cm2
  • Female patients of childbearing potential must agree to practice adequate methods of birth control to prevent pregnancy during the study
  • Patients who voluntarily agreed to enroll in the study and signed an informed consent form

Exclusion Criteria:

  • Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results
  • Patients taking steroidal anti-inflammatory medications within 14 days of baseline visit unless washed out
  • Patients with ongoing infectious disease, including HIV
  • Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, Type I diabetes
  • Patients who are pregnant or currently breast-feeding children
  • Patients who were enrolled in any other clinical trials within the past 30 days
  • Patients who had been administered with oriental medicine, glucosamine and chondroitin within 14 days of baseline visit
  • Patients who had been administered with immunosuppressants and antirheumatic drugs within the past 3 months
  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: February 17, 2014
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 October 23, 2014