Safety Study of TissueGene-C in Degenerative Joint Disease of the Knee

Completed · Phase 1 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

The study is being conducted to investigate the safety and activity of TissueGene-C injected into the knee joint of patients with chronic degenerative joint disease (DJD) who will be undergoing total knee replacement.

Key facts

Study ID

NCT00599248

Run by

Kolon TissueGene, Inc.

People needed

12

Starts

2007-01-01

Expected to finish

2010-05-01

Last updated by the study team

2017-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female subjects
• Age 18 years and older
• In general good health as evidenced by physical examination, normal hematology, serum chemistry, and urinalysis screening laboratory results, and a negative history of significant organ system disorders. All laboratory values must be within 20% of normal ranges.
• Patients with Degenerative Joint Disease (DJD) of the knee that is refractory to existing drug therapies and who are scheduled for Total Knee Arthroplasty.
• Based on Radiographic findings, defect should be more than 2 cm.
• Patients providing written informed consent, after the nature of the study, are fully explained.
• Body Mass Index (BMI) should be between '18.5 - 45.5'. The applied scale is the same for both men and women.
• Blood Pressure measurements - Systolic Blood Pressure (SBP) should be between 90-160mm. Hg, and Diastolic Blood Pressure (DBP) between 50-90mm.Hg,
• Osteoarthritis confirmed by the Radiographic Criteria of Kellgren and Lawrence
• Symptom of pain for more than four (4) consecutive months and intensity greater than Grade 4 on the 11-point numeric scale.

You may not qualify if…

• Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results
• Patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit
• Patients with a recent (within 1 year) history of drug abuse and/or a positive urine drug/alcohol test at the time of screening
• Patients receiving injections to the treated knee within 2 months prior to study entry
• Patients who are pregnant or currently breast-feeding children
• Patients with systemic, rheumatic, or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, necrosis of the femoral condyle, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis.
• Patients with ongoing infectious disease, including HIV and hepatitis
• Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or Type I diabetes
• Patients participating in a study of an experimental drug or medical device within 30 days of study entry.
• Positive drug screen at screening visit

Where it is running

• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• Commonwealth Orthopedics — Arlington, Virginia, United States

Full record on ClinicalTrials.gov

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