Safety Study of TissueGene-C in Degenerative Joint Disease of the Knee (TGC-03-01)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|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 incidence and severity of observations at the site of administration, the incidence and severity of adverse events assessed through 28 days after treatment and changes in clinical lab measurements [ Time Frame: Days 0, 3, 7, 11, 28, 29 and at 3, 6, 9, and 12 months following dosing ] [ Designated as safety issue: Yes ]
- The evaluation of regeneration of hyaline cartilage as determined by histological analysis of resected knee tissue and observation for engraftment and cartilage production. [ Time Frame: 0, 3, 7, 11, 28 (prior to surgery), and day 29 (one day post-surgery) following dosing. Follow-up patient monitoring will be performed at 3, 6, 9, and 12 months following dosing ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint
TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection
Placebo Comparator: 2
Placebo control (DMEM)
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:
- Evaluate the dose response of the hChonJb#7 cells in grafting at the defect as compared to the placebo control.
- Evaluate distribution of hChonJb#7 cells out of the injection site.
- Evaluate the regeneration of hyaline cartilage as determined by the histological analysis of the resected knee tissue.
- Evaluate the joint for evidence of tissue overgrowth or transformation.
- Evaluate the biological activity of TissueGene-C on joint pain, range of motion and functionality as compared to the placebo control
|United States, Maryland|
|Sinai Hospital of Baltimore|
|Baltimore, Maryland, United States, 21215|
|United States, Virginia|
|Arlington, Virginia, United States, 22205|
|Principal Investigator:||Michael Mont, MD||Sinai Hospital of Baltimore|
|Principal Investigator:||David Romness, MD||Commonwealth Orthopedics, Virginia Hospital Center|