Osteoarthritis, Knee Clinical Trial
Official title:
A Phase 1 Study to Determin the Safety and Biological Activity of Cell-Mediated Gene Therapy Using TissueGene-C in Patients With Degenerative Joint Disease Prior to Total Knee Arthroplasty
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.
The purpose of this first human study is to investigate the safety and biological activity
of intra-articularly applied TissueGene-C in patients with chronic degenerative joint
disease (DJD) who will be undergoing total knee replacement. In addition, data on joint
pain, range of motion, and functionality will be obtained in this patient population prior
to total knee replacement.
The primary objective of this study is to evaluate the safety and biological activity of
intra-articularly administered TissueGene-C as evidenced by observation of the injection
site for irritation or other abnormalities affecting the incidence and severity of adverse
events, and the changes in physical examination findings and laboratory tests as compared to
the placebo control.
The secondary objectives of this study are to:
1. Evaluate the dose response of the hChonJb#7 cells in grafting at the defect as compared
to the placebo control.
2. Evaluate distribution of hChonJb#7 cells out of the injection site.
3. Evaluate the regeneration of hyaline cartilage as determined by the histological
analysis of the resected knee tissue.
4. Evaluate the joint for evidence of tissue overgrowth or transformation.
5. Evaluate the biological activity of TissueGene-C on joint pain, range of motion and
functionality as compared to the placebo control
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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