A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Study to Determine the Efficacy of TG-C in Subjects With Kellgren and Lawrence Grade (KLG) 2 or 3 Osteoarthritis of the Knee
Overview
- Phase
- Phase 3
- Intervention
- TG-C
- Conditions
- Degenerative Osteoarthritis
- Sponsor
- Kolon TissueGene, Inc.
- Enrollment
- 535
- Locations
- 46
- Primary Endpoint
- Change in Knee Function as Assessed by the Western Ontario and McMaster Universities Index (WOMAC)
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Active Treatment (TG-C)
TG-C at 3 x 10e7 cells per single 2 mL intraarticular injection
Intervention: TG-C
Placebo Control (Normal Saline)
Normal saline, single 2 mL intraarticular injection
Intervention: Placebo Control
Outcomes
Primary Outcomes
Change in Knee Function as Assessed by the Western Ontario and McMaster Universities Index (WOMAC)
Time Frame: 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
Time Frame: 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 Outcomes
- PCS of the SF-12 Questionnaire(12 months)
- WOMAC Total Score(24 months)
- Health Assessment Questionnaire Disability Index(12 months)
- MRI Assessment of Target Knee(12 months)