Study to Determine the Efficacy and Safety of TG-C in Subjects with Kellgren/Lawrence Grade 2 or 3 OA of the Knee
- Conditions
- Degenerative Osteoarthritis
- Interventions
- Biological: Placebo Control
- Registration Number
- NCT03291470
- Lead Sponsor
- Kolon TissueGene, Inc.
- Brief Summary
A randomized, double-blind, placebo-controlled, multi-center, phase 3 study to determine the efficacy and safety of TG-C in subjects with Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee, Osteoarthritis Research Society International (OARSI) medial joint space narrowing (JSN) Grade 1 or 2 of the knee joint. TG-C is to be administered by a single intra-articular injection to the damaged joint area via ultrasound guidance. Patients will be followed for 24 months for safety and efficacy.
- Detailed Description
This protocol is designed to assess the safety and efficacy of TG-C in treating symptoms of osteoarthritis of the knee and determining disease modifying effects of TG-C. This study is intended for the treatment of patients with K\&L Grade 2 and 3 osteoarthritis and OARSI JSN Grade 1 and 2. Assessments will be made on both the symptomatic effects of pain (VAS), function (WOMAC), and Quality of Life (SF-12) as well as the physical effects (JSW, MRI evaluations of whole knee joint organ tissues and structure) and biochemical biomarkers. This is a placebo-controlled study, TG-C will be compared to normal saline as a control. Additionally, this protocol is designed to evaluate the safety of TG-C. Safety will be evaluated by observation of the injection site for irritation or other effects, the incidence and severity of adverse events, and changes in physical examination findings, radiographic criteria, and laboratory tests. Patients will be followed for 24 months for both safety and efficacy with annual cancer surveillance questionnaires through 15 years post dose for subjects who do not enroll in the Long Term Safety study.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 531
- Aged 40 or older
- BMI between 18.5 and 40
- KL Grade 2 or 3 knee OA
- OARSI Grade 1 or 2 medial JSN
- Pain >= 40 on VAS scale
- Written informed consent
- Using birth control
- Knee symptoms that result in difficulty or inability to walk
- Knee effusion >2+
- Has Grade 3 OARSI JSN
- MRI exam indicates fracture or tumor
- Has a positive result on RCR testing at screening
- Has taken NSAIDS with 14 days of baseline
- Has taken steroidal anti-inflammatory or biologic therapy medication within 2 months of baseline
- Chronic (>21 days) narcotic use
- Recent history (within 1 year) of drug or alcohol abuse
- Pregnant or lactating
- Has received injection to target knee within 2 months prior to study entry
- History of various disorders of the knee including but not limited to rheumatoid arthritis, psoriatic arthritis, autoimmune disorder, chondrocalcinosis, gout, hemochromatosis, villonodular synovitis, or synovial chondromatosis
- Severe hip osteoarthritis ipsilateral to the target knee
- Ongoing infectious disease including but not limited to HIV, HTLV-1, VSV-G, HBV, or HCV.
- Clinically significant congestive heart failure, hepatic disease, kidney disease, adrenal insufficiency, acromegaly, uncontrolled hyper- or hypothyroidism, or non-specified uncontrolled endocrine disorder.
- Uncontrolled diabetes based on a HbA1c > 8% at screening.
- Documented active malignancy within the last 5 years except for basal cell carcinoma, squamous cell carcinoma, and benign pigmented nevi.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Treatment (TG-C) TG-C TG-C at 3 x 10e7 cells per single 2 mL intraarticular injection Placebo Control (Normal Saline) Placebo Control Normal saline, single 2 mL intraarticular injection
- Primary Outcome Measures
Name Time Method Change in Knee Pain as Assessed by VAS 12 months Assessment of change from baseline in target knee pain using the Visual Analog Scale (VAS). The VAS is a method for the assessment of the intensity of pain. The VAS is a horizontal line, 100 mm in length and anchored by word descriptors at each end (no pain, very severe pain). The patient marks on the line at the point that represents their current state. The VAS score is determined by measuring in millimeters from the left hand end to the point of the mark. The score ranges from "0" or no pain to "100" very severe pain.
Change in Knee Function as Assessed by the Western Ontario and McMaster Universities Index (WOMAC) 12 months Assessment of change from baseline in target knee function using the WOMAC Osteoarthritis Index. The WOMAC is a proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee including pain, stiffness, and physical functioning of the joints. The response to the questions is in the form of a checked box associated with the response; None, Mild, Moderate, Severe and Extreme.
- Secondary Outcome Measures
Name Time Method MRI Assessment of Target Knee 12 months Assessment of knee organ tissues and structure by comparing change in MRI scoring using WORMS and partial MRI Osteoarthritis Knee Score (MOAKS)
PCS of the SF-12 Questionnaire 12 months Evaluation of the change from baseline in physical component score (PCS) of the SF-12v2 questionnaire.
WOMAC Total Score 24 Months Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score
Health Assessment Questionnaire Disability Index 12 months Evaluation of the change from baseline in the disability index of the Health Assessment Questionnaire (HAQ-DI)
Trial Locations
- Locations (27)
Haresh Boghara
🇺🇸Red Oak, Texas, United States
Igor Grosman
🇺🇸Brooklyn, New York, United States
David Scott
🇺🇸Spokane, Washington, United States
Priyesh Mehta
🇺🇸Dayton, Ohio, United States
Samy Metyas
🇺🇸Covina, California, United States
Jeremy Hoff
🇺🇸Wilmington, North Carolina, United States
Jonathan Samuels
🇺🇸New York, New York, United States
Bassil Aish
🇺🇸Huntington Beach, California, United States
Peter Hanson
🇺🇸La Mesa, California, United States
Larkin Wadsworth
🇺🇸Saint Louis, Missouri, United States
Steve Sitar
🇺🇸Anaheim, California, United States
John Beckes
🇺🇸San Diego, California, United States
Mira Baron
🇺🇸West Palm Beach, Florida, United States
Thomas Schnitzer
🇺🇸Chicago, Illinois, United States
Duane C Anderson
🇺🇸Las Vegas, Nevada, United States
James Lilly
🇺🇸Dallas, Texas, United States
Nebojsa Skrepnik
🇺🇸Tucson, Arizona, United States
Edward Tavel
🇺🇸Charleston, South Carolina, United States
Richard Radnovich
🇺🇸Boise, Idaho, United States
Nathan Rimmke
🇺🇸Rochester Hills, Michigan, United States
John Solic
🇺🇸Durham, North Carolina, United States
Charles Andrews
🇺🇸San Antonio, Texas, United States
Leonel Reyes
🇺🇸San Antonio, Texas, United States
Miguel Trevino
🇺🇸Clearwater, Florida, United States
Jan Hommen
🇺🇸Doral, Florida, United States
Stuart Silverman
🇺🇸Beverly Hills, California, United States
Manjoo Sharma
🇺🇸Lewisville, Texas, United States