Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren/Lawrence Grade 2 or 3 OA of the Knee
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| ClinicalTrials.gov Identifier: NCT03291470 |
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Recruitment Status :
Recruiting
First Posted : September 25, 2017
Last Update Posted : April 25, 2023
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Sponsor:
Kolon TissueGene, Inc.
Information provided by (Responsible Party):
Kolon TissueGene, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Degenerative Osteoarthritis | Biological: TG-C Biological: Placebo Control | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 510 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Double-blind |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | December 9, 2021 |
| Estimated Primary Completion Date : | August 30, 2024 |
| Estimated Study Completion Date : | August 30, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Osteoarthritis
MedlinePlus related topics:
Osteoarthritis
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Active Treatment (TG-C)
TG-C at 3 x 10e7 cells per single 2 mL intraarticular injection
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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 |
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Placebo Comparator: Placebo Control (Normal Saline)
Normal saline, single 2 mL intraarticular injection
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Biological: Placebo Control
2 mL normal saline intraarticular injection
Other Name: Normal Saline |
Primary Outcome Measures :
- 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 Outcome Measures :
- PCS of the SF-12 Questionnaire [ Time Frame: 12 months ]Evaluation of the change from baseline in physical component score (PCS) of the SF-12v2 questionnaire.
- Health Assessment Questionnaire Disability Index [ Time Frame: 12 months ]Evaluation of the change from baseline in the disability index of the Health Assessment Questionnaire (HAQ-DI)
- MRI Assessment of Target Knee [ Time Frame: 12 months ]Assessment of knee organ tissues and structure by comparing change in MRI scoring using WORMS and partial MRI Osteoarthritis Knee Score (MOAKS)
- WOMAC Total Score [ Time Frame: 24 Months ]Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score
Other Outcome Measures:
- 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
- Radiography for Structural Change in Knee Joint [ Time Frame: 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: Week 1, Months 3, 6, 9, 12, 18, and 24 ]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: 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: 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
- European Quality of Life-Five Dimensions Questionnaire (EQ-5D-5L) [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]Evaluate health outcomes using the European Quality of Life-Five Dimensions Questionnaire (EQ-5D-5L)
Information from the National Library of Medicine
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291470
Contacts
| Contact: Aaron Harrison | (984) 234-3215 | KTGclinical@tissuegene.com |
Locations
Show 38 study locations
Sponsors and Collaborators
Kolon TissueGene, Inc.
Investigators
| Study Chair: | Moon Jong Noh, PhD | Kolon TissueGene |
| Responsible Party: | Kolon TissueGene, Inc. |
| ClinicalTrials.gov Identifier: | NCT03291470 |
| Other Study ID Numbers: |
TGC-15302 |
| First Posted: | September 25, 2017 Key Record Dates |
| Last Update Posted: | April 25, 2023 |
| Last Verified: | April 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Kolon TissueGene, Inc.:
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knee |
Additional relevant MeSH terms:
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Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |