Efficacy and Safety Study of TissueGene-C Mixed With Fibrin-glue for the Patients With Degenerative Arthritis
A Single-blind, Randomized, Parallel-group, Multi-center Phase 2 Study to Determine the Efficacy and Safety of TissueGene-C Mixed With Fibrin-glue in Patients With Degenerative Arthritis
1 other identifier
interventional
18
1 country
6
Brief Summary
The purpose of this study is to determine whether TissueGene-C, allogeneic human chondrocytes expressing Transforming Growth Factor(TGF)-b1, mixed with fibrin-glue is effective and safe in patients with degenerative arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2012
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 3, 2013
CompletedFirst Posted
Study publicly available on registry
April 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJanuary 22, 2015
January 1, 2015
1.5 years
April 3, 2013
January 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in IKDC Subjective Knee Evaluation
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
Week 0 and 48
Secondary Outcomes (8)
Changes in WOMAC scores
Week 0, 24 and 48
Changes in KOOS scores
Week 0, 24 and 48
Changes in 100 mm-VAS
Week 0, 24 and 48
Comparative Evaluation of Knee Magnetic Resonance Images (MRIs)
Week 0, 24 and 48
Changes in ICRS Cartilage Repair Assessment
week 0 and 48
- +3 more secondary outcomes
Study Arms (2)
TissueGene-C (Low dose)
EXPERIMENTALTissueGene-C (1.0 x 10\^6 cells per cm\^2 of the cartilage defect) combined with fibrin-glue
Experimental: TissueGene-C (High dose)
EXPERIMENTALTissueGene-C (3.0 x 10\^6 cells per cm\^2 of the cartilage defect) combined with fibrin-glue
Interventions
TissueGene-C at 1.0 x 10\^6 cells mixed with fibrin-glue
TissueGene-C at 3.0 x 10\^6 cells mixed with fibrin-glue
Eligibility Criteria
You may qualify if:
- Female or male aged 18 years or more
- Diagnosed with degenerative arthritis of the knee
- With an IKDC score of 60 or lower at the screening visit
- With a BMI of higher than18.5 and lower than 30
- With an International Cartilage Repair Society(ICRS) Grade IV cartilage damage in the major lesions, as confirmed through an MRI scan
- With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms
- With major lesions defect size 2 cm2 \~ 10cm2
- With no alleviation of the symptoms even after at least three months of non-surgical treatment
- Healthy, with no major findings from the physical examination, hematology, serum chemistry, and urine tests, and no significant medical history
- Agreed to use an effective contraceptive method during the study period
- Voluntarily agreed to participate in this study, and signed the informed consent form
You may not qualify if:
- Showed clinically significant hematology, serum chemistry, and urine test results at the screening visit
- Mechanical axis (HKA) is greater than 5°
- Patients receiving injections to the treated knee within 2 months prior to study entry
- Patients who are pregnant or currently breast-feeding children
- With another joint disease (e.g., inflammatory arthritis, infectious arthritis)
- With an infectious disease, including HIV or hepatitis
- With any of the following clinically significant diseases:
- heart disease \[e.g., myocardial infarction, arrhythmia, other serious heart diseases,
- 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)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Kyungpook National University Hospital
Daegu, 700-721, South Korea
Inha University Hospital
Incheon, 400-711, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 158-710, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Myung Chul Lee, MD, PhD
Seoul National University Hospital
- PRINCIPAL INVESTIGATOR
Chul Won Ha, MD, PhD
Samsung Medical Center
- PRINCIPAL INVESTIGATOR
Seong Il Bin, MD, PhD
Asan Medical Center
- PRINCIPAL INVESTIGATOR
Myung Gu Kim, MD, PhD
Inha University Hospital
- PRINCIPAL INVESTIGATOR
Jae Doo Yoo, MD, PhD
Ewha Womans University Mokdong Hospital
- PRINCIPAL INVESTIGATOR
Hee Su Kyung, MD, PhD
Kyungpook National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2013
First Posted
April 8, 2013
Study Start
October 1, 2012
Primary Completion
April 1, 2014
Study Completion
June 1, 2014
Last Updated
January 22, 2015
Record last verified: 2015-01