Study of TG-C in Patients With Grade 3 Degenerative Joint Disease of the Knee
The purpose of this study is to see if we can safely regenerate cartilage without invasive surgery using a biologic product called TissueGene-C.
Drug: Normal Saline
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase II Study to Determine the Efficacy and Safety of Allogeneic Human Chondrocytes Expressing TGF-β1 (TissueGene-C) in Patients With Grade 3 Chronic Degenerative Joint Disease of the Knee|
- Knee Symptoms, Pain and Function Determined by the International Knee Documentation Committee (IKDC) Subjective Knee Evalution [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Symptoms, pain and function of the knee joint will be determined and scored using the IKDC Subjective Knee Evaluation
- Reduction in Pain as Determined by a Visual Analog Scale (VAS) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Reduction in pain as measured by a 100 mm visual analog scale
- Knee Symptoms, Pain and Functionality as Determined by the Knee Injury and Osteoarthritis Outcome Score(KOOS) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Symptoms, pain and functionality of the knee joint as determined by Knee Injury and Osteoarthritis Outcome Score (KOOS)
- Articular Cartilage Damage in the Knee as Determined by the Lysholm Knee Score [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Articular cartilage damage in the knee will be measured by the Lysholm Knee Scale
- Comparative Evaluation of Knee Magnetic Resonance Images (MRIs) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Comparison of pre-procedure 3T MRI scans to those obtained at months 3, 6, and 12 following dose administration by an independent radiographic reviewer. Evaluations will be scored using Whole Organ Magnetic Resonance imaginge Score (WORMS) and Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART).
- Pain reduction assessed by medication usage [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Reduction in pain as measured by a questionnaire and the incidence and dose of analgesia.
- Anti-inflammatory Medication Usage [ Time Frame: 2 Years ] [ Designated as safety issue: No ]The incidence and dose of anti-inflammatory medications
- Knee Function as Determined by the Lower Extremity Functional Scale [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Assessment of knee function as determined by the Lower Extremity Functional Scale (LEFS)
- The Incidence of Total Knee Arthroplasty [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Quantification of the incidence of total knee arthroplasty of the treated knee subsequent to treatment with TissueGene-C
- The Incidence and Severity of Injection Site Reactions [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]The incidence and severity of observations of the administration site including swelling, irritation, immune reaction or other abnormalities
- The Incidence and Severity of Adverse Events in Treated Patients [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]The incidence and severity of adverse events assessed through 730 days (24 months) after dose administration
- Clinically Significant Changes in Hematology and Urinalysis Parameters [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]The changes in clinical hematology, chemistry, and urinalysis test results at each time point from dose administration through day 730 (24 months).
- General Health as Determined by a Validated Standardized Questionnaire [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]A SF-36 Questionnaire will be completed by subjects every six months (Baseline Visit and 6, 12, 18, and 24 month visits)
- International Cartilage Repair Society (ICRS) Histological Scoring of Resected Knee Tissue [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]For those patients undergoing a total knee arthroplasty procedure during the study period, the resected knee tissue will undergo histological analysis and scored according to the ICRS scoring system (Mainil-Varlet et al., 2003).
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||October 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
Single intraarticular injection at 3 x 10e7 cells
Other Name: TG-C
Placebo Comparator: Placebo Control
Normal Saline injection
Drug: Normal Saline
Single intraarticular injection of normal saline as a placebo control
Protocol TGC09201 is a multi-center, double-blind, placebo-controlled, randomized study. A total of one hundred (100) adults with grade 3 chronic degenerative joint disease (DJD) of the knee joint (as determined by radiographic examination) will be enrolled into the study. TissueGene-C will be administered intra-articularly once via x-ray guidance. TissueGene-C will be administered at a dose of 3 x 10e7 cells. Patients receiving control treatment will receive a single normal saline injection.
The objectives of this study are to:
- Evaluate the efficacy of TissueGene-C with regard to knee functionality and symptoms of knee osteoarthritis including pain.
- Evaluate the safety of administration of a single intra-articular dose of TissueGene-C as evidenced by observation of the injection site for irritation or other abnormalities, the incidence and severity of adverse events, and the changes in physical examination findings and laboratory tests, including immune analyses.
- Evaluate the incidence and dose of analgesia and/or anti-inflammatory medication.
- Evaluate the regeneration of hyaline cartilage as determined by 3T magnetic resonance imaging (MRI).
- Evaluate distribution of hChonJb#7 cells out of the injection site.
- Evaluate the efficacy of TissueGene-C by evaluating the need for total knee arthroplasty after treatment
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221441
|United States, Florida|
|Advent Clinical Research|
|Pinellas Park, Florida, United States, 33781|
|United States, Maryland|
|Sinai Hospital of Baltimore|
|Baltimore, Maryland, United States, 21215|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|
|State College, Pennsylvania, United States, 16801|
|United States, Virginia|
|Arlington, Virginia, United States, 22205|
|Principal Investigator:||Michael A Mont, MD||Sinai Hospital of Baltimore|
|Principal Investigator:||David W Romness, MD||Commonwealth Orthopedics, Virginia Hospital Center|