A Study to Determine the Safety and Efficacy of TG-C in Subjects with Kellgren and Lawrence Grade 2 or 3 OA of the Knee
- Conditions
- Degenerative Osteoarthritis
- Interventions
- Biological: Placebo Control
- Registration Number
- NCT03203330
- Lead Sponsor
- Kolon TissueGene, Inc.
- Brief Summary
A randomized, double-blind, placebo-controlled, multi-center, phase 3 study to determine the safety and efficacy 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 KL 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 dosing for subjects who do not enroll in the Long Term Safety study.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 535
- 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
- Has a score of 0 or >=5 on the cartilage feature of the WORMS at Screening
- 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 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 OA, chondrocalcinosis, gout, hemochromatosis, villonodular synovitis, or synovial chondromatosis
- Severe hip osteoarthritis ipsilateral to the target knee
- Ongoing infection disease including but not limited to HIV, Hepatitis B or C.
- 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
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 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.
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.
- Secondary Outcome Measures
Name Time Method PCS of the SF-12 Questionnaire 12 months Evaluation the Health-Related Quality of Life (HRQoL) as measured by the physical component score (PCS) of the 12-Item Short-Form Health Survey version 2 (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 HRQoL as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI)
MRI Assessment of Target Knee 12 months Evaluation of the features of OA, as determined by structural changes of the knee joint, assessed by MRI
Trial Locations
- Locations (46)
Jeffrey Davis
🇺🇸Birmingham, Alabama, United States
Bradly Goodman
🇺🇸Birmingham, Alabama, United States
Saima Chohan
🇺🇸Phoenix, Arizona, United States
Nebojsa Skrepnik
🇺🇸Tucson, Arizona, United States
Diraj Karnani
🇺🇸Apple Valley, California, United States
Dan La
🇺🇸Covina, California, United States
Scott Hacker
🇺🇸La Mesa, California, United States
Eric Grigsby
🇺🇸Napa, California, United States
Arthur Mabaquiao
🇺🇸San Diego, California, United States
Timothy Davis
🇺🇸Santa Monica, California, United States
Tien-I Su
🇺🇸Whittier, California, United States
Mehul Desai
🇺🇸District of columbia, District of Columbia, United States
David Billmeier
🇺🇸Daytona Beach, Florida, United States
Mercedes Ponce De Leon
🇺🇸Miami, Florida, United States
Aurelio Torres-Consuegra
🇺🇸Miami, Florida, United States
Edgar Gonzalez
🇺🇸Miami, Florida, United States
Cathy Barnes
🇺🇸New Port Richey, Florida, United States
Howard Chipman
🇺🇸Oldsmar, Florida, United States
Richard Linn
🇺🇸Sunrise, Florida, United States
Anand Patel
🇺🇸Winter Park, Florida, United States
Sandeep Vaid
🇺🇸Newnan, Georgia, United States
Manish Jain
🇺🇸Chicago, Illinois, United States
Dennis Levinson
🇺🇸Chicago, Illinois, United States
Hythem Shadid
🇺🇸Oak Brook, Illinois, United States
Adil Fatakia
🇺🇸Marrero, Louisiana, United States
Ronald Delanois
🇺🇸Baltimore, Maryland, United States
Melvin Churchill
🇺🇸Lincoln, Nebraska, United States
Corey Hunter
🇺🇸New York, New York, United States
Jason Oh
🇺🇸New York, New York, United States
Brett Gilbert
🇺🇸Durham, North Carolina, United States
Jeremy Hoff
🇺🇸Wilmington, North Carolina, United States
Yogesh Mittal
🇺🇸Tulsa, Oklahoma, United States
Alan Kivitz
🇺🇸Duncansville, Pennsylvania, United States
Edward Tavel
🇺🇸Columbia, South Carolina, United States
Eric Loudermilk
🇺🇸Greenville, South Carolina, United States
Harvey Bowles
🇺🇸Nashville, Tennessee, United States
Daneshvari Solanki
🇺🇸Bellaire, Texas, United States
Amr Morsy
🇺🇸Dallas, Texas, United States
Haresh Boghara
🇺🇸DeSoto, Texas, United States
Aldo Maspons
🇺🇸El Paso, Texas, United States
Subodh Bhuchar
🇺🇸Houston, Texas, United States
Brian MacGillivray
🇺🇸San Antonio, Texas, United States
Angela Krull
🇺🇸Draper, Utah, United States
John Hemmersmeier
🇺🇸South Ogden, Utah, United States
James Clark
🇺🇸Charlottesville, Virginia, United States
Mark Hermann
🇺🇸Danville, Virginia, United States