Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis
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
1 other identifier
interventional
28
1 country
3
Brief Summary
To assess the efficacy and safety of the intra-articular injection of TissueGene-C in patients with degenerative arthritis of the knee
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 Aug 2009
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 8, 2015
CompletedFirst Posted
Study publicly available on registry
January 19, 2015
CompletedJanuary 22, 2015
January 1, 2015
10 months
January 8, 2015
January 21, 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, 12 and 24
Secondary Outcomes (5)
Changes in WOMAC scores
Week 0, 12 and 24
Changes in 100 mm-VAS
Week 0, 12 and 24
Comparative Evaluation of Knee MRI
Week 0, 12 and 24
Number of Participants with Adverse Events
Week 0, 2, 4, 12 and 24
Evaluation of Physical examination and laboratory tests
Week 0, 2, 4, 12 and 24
Study Arms (2)
TissueGene-C (Low dose)
EXPERIMENTALSingle intra-articular injection to the damaged knee joint at a dose of 6.0 x 10\^6 cells
TissueGene-C (High dose)
EXPERIMENTALSingle intra-articular injection to the damaged knee joint at a dose of 1.8 x 10\^7 cells
Interventions
Eligibility Criteria
You may qualify if:
- Male or female, aged 45 years or more
- With grade 4 degenerative arthritis of the knee \[based on the International Cartilage Repair Society(ICRS) evaluation criteria from the MRI results\]
- With less than 6 cm2major lesions
- With major lesions (grade 4) concentrated in only one section of the knee and considered the main cause of the clinical symptoms
- Unresponsive to conventional symptomatic treatment
- Healthy and with no major physical examination, hematology, serum chemistry, and urine test findings 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:
- Abnormal screening laboratory test (hematology, serum, and urine test) findings
- Took anti-inflammatory medications (prescribed or over-the-counter), including natural medicines, within 14 days before the injection of the investigational product
- Took antirheumatic drugs (e.g., methotrexate or antimetabolites) within three months before enrollment in this study
- 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
- Received an injection in the target knee within two months before enrollment in this study
- Pregnant or breastfeeding female
- 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)
- With a current infectious disease, including HIV or hepatitis
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Samsung Medical Center
Gangnam-gu, Seoul, 135-710, South Korea
Seoul National Univ. Hospital
Seoul, 110-744, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Related Publications (1)
Ha CW, Cho JJ, Elmallah RK, Cherian JJ, Kim TW, Lee MC, Mont MA. A Multicenter, Single-Blind, Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of a Cell-Mediated Gene Therapy in Degenerative Knee Arthritis Patients. Hum Gene Ther Clin Dev. 2015 Jun;26(2):125-30. doi: 10.1089/humc.2014.145. Epub 2015 Apr 17.
PMID: 25760423DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chul-won Ha, MD, PhD
Samsung Medical Center
- PRINCIPAL INVESTIGATOR
Myung-chul Lee, MD, PhD
Seoul 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
January 8, 2015
First Posted
January 19, 2015
Study Start
August 1, 2009
Primary Completion
June 1, 2010
Study Completion
October 1, 2010
Last Updated
January 22, 2015
Record last verified: 2015-01