The purpose of this study is to see if we can safely regenerate cartilage without invasive surgery using a biologic product called TissueGene-C.
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: 1. Evaluate the efficacy of TissueGene-C with regard to knee functionality and symptoms of knee osteoarthritis including pain. 2. 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. 3. Evaluate the incidence and dose of analgesia and/or anti-inflammatory medication. 4. Evaluate the regeneration of hyaline cartilage as determined by 3T magnetic resonance imaging (MRI). 5. Evaluate distribution of hChonJb#7 cells out of the injection site. 6. Evaluate the efficacy of TissueGene-C by evaluating the need for total knee arthroplasty after treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
102
Single intraarticular injection at 3 x 10e7 cells
Single intraarticular injection of normal saline as a placebo control
Advent Clinical Research
Pinellas Park, Florida, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Rothman Institute
Philadelphia, Pennsylvania, United States
University Orthopedics
State College, Pennsylvania, United States
Change From Baseline in the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 1 Year
Symptoms, pain and function of the knee joint determined and scored using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation (Total Score, range 0-100 with higher scores better). Linear mixed model used for analysis.
Time frame: 1 Year
Change From Baseline in Visual Analog Scale (VAS) Score at 1 Year
Reduction in pain as measured by a 100 mm visual analog scale (0= no pain; 100 = extreme pain) from Baseline to 1 Year. Linear mixed model used for analysis.
Time frame: 1 Year
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 Years
Symptoms, pain and functionality of the knee joint as determined by Total Score of the Knee Injury and Osteoarthritis Outcome Score (KOOS) (Range 0-100 with higher scores indicating healthier outcomes). Linear mixed model used for analysis.
Time frame: 2 Years
Change From Baseline in Articular Cartilage Damage in the Knee as Determined by the Lysholm Knee Score at 2 Years
Measurement to assess outcomes of various chondral disorders of the knee determined by the Lysholm Knee Scale (Range 0-100 with higher scores better). Linear mixed model used for analysis.
Time frame: 2 Years
Comparative Evaluation of Knee Magnetic Resonance Images (MRIs) From Baseline to 1 Year
Comparison of pre-procedure 3T MRI scans to those obtained at months 12 following dose administration by an independent radiographic reviewer. Evaluations will be scored using Whole Organ Magnetic Resonance imaging Score (WORMS) Cartilage Morphology Subscore (Range 0-6, with higher scores being worse)
Time frame: 1 Year
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Commonwealth Orthopedics
Arlington, Virginia, United States
Change in Pain Severity From Baseline to 2 Years as Assessed by Questionnaire
Change in pain severity (on a scale from 1 to 4) from baseline to 2 years as measured by a questionnaire (lower scores better)
Time frame: 2 Years
Number of Participants With Change in Pain Severity Measured by Incidence and Dose of Analgesia
The number of participants that had a change in pain severity as measured by the incidence and dose of analgesic medications
Time frame: 2 Years
Change From Baseline in Knee Function as Determined by the Lower Extremity Functional Scale at 2 Years
Assessment of knee function as determined by the Lower Extremity Functional Scale (LEFS); change from baseline to 2 years (Range 0-80 with higher scores signifying lower difficulty in performing knee functions)
Time frame: 2 Years
The Incidence of Total Knee Arthroplasty
Quantification of the incidence of total knee arthroplasty of the treated knee subsequent to treatment with TissueGene-C
Time frame: 2 Years
The Number of Patients Experiencing Injection Site Reactions Related to Treatment
The number of patients with observations of the administration site deemed related to treatment with either active or placebo, including arthralgia, swelling, irritation, pain, stiffness or abnormalities
Time frame: 2 Years
The Incidence and Severity of Adverse Events in Treated Patients
The incidence and severity of adverse events assessed through 104 weeks (2 years) after dose administration
Time frame: 2 Years
Number of Participants With Adverse Events Due to Clinically Significant Changes in Hematology and Urinalysis Tests
The number of participants with changes in clinical hematology, chemistry, and urinalysis test results through 2 years that were considered Adverse Events
Time frame: 2 Years
Change in SF-36 General Health Assessment Questionnaire (Overall Score) From Baseline to 2 Years
Overall assessment of general health as determined by scoring use an SF-36 Questionnaire (Range 0-100 with higher scores better - indicating less disability)
Time frame: 2 Years