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Trial record 1 of 1 for:    TGC12301 | Osteoarthritis
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03203330
Recruitment Status : Active, not recruiting
First Posted : June 29, 2017
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Kolon TissueGene, Inc.

Tracking Information
First Submitted Date  ICMJE June 21, 2017
First Posted Date  ICMJE June 29, 2017
Last Update Posted Date May 13, 2020
Actual Study Start Date  ICMJE October 30, 2018
Estimated Primary Completion Date October 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
  • Knee Function as Assessed by WOMAC [ Time Frame: 12 months ]
    Assessment of improvement from baseline in target knee function using the WOMAC Osteoarthritis Index
  • Knee Pain as Assessed by VAS [ Time Frame: 12 months ]
    Assessment of improvement from baseline in target knee pain using the Visual Analog Scale (VAS)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2018)
  • MRI Assessment of Target Knee [ Time Frame: 12 months ]
    Evaluation of the features of OA, as determined by structural changes of the knee joint, assessed by MRI
  • PCS of the SF-12 Questionnaire [ Time Frame: 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 [ Time Frame: 24 months ]
    Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score
  • Health Assessment Questionnaire Disability Index [ Time Frame: 12 months ]
    Evaluation of the HRQoL as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
  • International Knee Documentation Committee (IKDC) Scoring of Knee Symptoms, Pain and Function [ Time Frame: 12 and 24 months ]
    Evaluation of target knee symptoms, joint pain, and functionality assessed using the IKDC Subjective knee evaluation
  • Change in Joint Space Width [ Time Frame: 12 and 24 months ]
    Evaluation of disease progression in target knee as ascertained by change from baseline in joint space width (JSW) determined using radiography
  • PCS of the SF-12 Questionnaire [ Time Frame: 12 and 24 months ]
    Evaluation of the change from baseline in physical component score (PCS) of the SF-12v2 questionnaire.
  • Health Assessment Questionnaire Disability Index [ Time Frame: Through 24 months ]
    Evaluation of the change from baseline in the disability index of the Health Assessment Questionnaire (HAQ-DI)
Current Other Pre-specified Outcome Measures
 (submitted: May 11, 2020)
  • Radiography for Structural Change in Knee Joint [ Time Frame: Through 24 months ]
    Evaluate structural changes of the knee joint as determined by radiography (X-ray)
  • Efficacy of TG-C with Regard to Knee Function via WOMAC Total Score [ Time Frame: At Months 3, 6, 9 and 18 ]
    Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score
  • Efficacy of TG-C with Regard to Knee Function via WOMAC Pain, Function, and Stiffness Scores [ Time Frame: Through 24 months ]
    Evaluate the efficacy of TG-C with regard to knee function via WOMAC® pain, function, and stiffness scores
  • Efficacy of TG-C with Regard to Knee Function via VAS Pain Score [ Time Frame: At Day 1, Week 1, and Months 1, 3, 6, 9, 18 and 24 ]
    Evaluation of the efficacy of TG-C with regard to knee function via VAS pain score at time points other than Month 12
  • OMERACT-OARSI Responder Analysis [ Time Frame: 12 and 24 months ]
    Analysis of response using the Outcomes Measures in Rheumatoid Arthritis Clinical Trials (OMERACT)-OARSI responder criteria
Original Other Pre-specified Outcome Measures
 (submitted: June 26, 2017)
  • MRI Assessment of Target Knee [ Time Frame: 6, 12 and 24 months ]
    Assessment of knee organ tissues and structure by comparing change in MRI scoring using WORMS and partial MRI Osteoarthritis Knee Score (MOAKS)
  • OMERACT-OARSI Responder Analysis [ Time Frame: 12 and 24 months ]
    Analysis of response using the Outcomes Measures in Rheumatoid Arthritis Clinical Trials (OMERACT)-OARSI responder criteria
  • Incidence and Severity of Injection Site Reactions [ Time Frame: Through 24 months ]
    Incidence and severity of swelling, irritation, or other reactions at the site of administration
  • Incidence and Severity of Adverse Events (AEs) [ Time Frame: Through 24 months ]
    Incidence and severity of adverse events assess after treatment
  • Radiography for Osteophytes [ Time Frame: 12 and 24 months ]
    Radiography for assessment of change from baseline in osteophytes by OARSI criteria
  • Changes in Laboratory Tests [ Time Frame: Through 24 months ]
    Changes from baseline in clinical laboratory test results
  • Biochemical Biomarker Analysis [ Time Frame: Through 24 months ]
    Assessment of changes from baseline in biochemical biomarkers of knee osteoarthritis
  • Frequency of Analgesia Use [ Time Frame: Through 24 months ]
    Evaluation of the frequency and dose of analgesia or anti-inflammatory medication use
  • MCS of the SF-12 Questionnaire [ Time Frame: Through 24 months ]
    Evaluation of the change from baseline in the eight domains of the mental component score (MCS) of the SF-12v2 questionnaire
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blind
Primary Purpose: Treatment
Condition  ICMJE Degenerative Osteoarthritis
Intervention  ICMJE
  • Biological: TG-C
    2 mL injection of non-transduced human chondrocytes and irradiated transduced human GP2-293 cells expressing TGF-B1.
    Other Name: TissueGene-C
  • Biological: Placebo Control
    2 mL normal saline injection
    Other Name: Normal Saline
Study Arms  ICMJE
  • Active Comparator: Active Treatment (TG-C)
    TG-C at 3 x 10e7 cells per single 2 mL intraarticular injection
    Intervention: Biological: TG-C
  • Placebo Comparator: Placebo Control (Normal Saline)
    Normal saline, single 2 mL intraarticular injection
    Intervention: Biological: Placebo Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2017)
510
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2024
Estimated Primary Completion Date October 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • WOMAC score <=70 for target knee
  • Written informed consent
  • Using birth control

Exclusion Criteria:

  • Knee symptoms that result in difficulty or inability to walk
  • Knee effusion >2+
  • Has Grade 0 OARSI JSN or atrophic OA
  • Has a score of >=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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03203330
Other Study ID Numbers  ICMJE TGC-12301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kolon TissueGene, Inc.
Study Sponsor  ICMJE Kolon TissueGene, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Moon Jong Noh, PhD Kolon TissueGene, Inc.
PRS Account Kolon TissueGene, Inc.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP