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
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| ClinicalTrials.gov Identifier: NCT03203330 |
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Recruitment Status :
Recruiting
First Posted : June 29, 2017
Last Update Posted : April 12, 2024
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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 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.
| 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 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 : | 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 of TG-C in Subjects With Kellgren and Lawrence Grade (KLG) 2 or 3 Osteoarthritis of the Knee |
| Actual Study Start Date : | October 30, 2018 |
| 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 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 :
- 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)
Other Outcome Measures:
- 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
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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
- 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
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): NCT03203330
Contacts
| Contact: Aaron Harrison | (910) 399-3238 | KTGclinical@tissuegene.com |
Locations
Show 47 study locations
Sponsors and Collaborators
Kolon TissueGene, Inc.
Investigators
| Study Chair: | Moon Jong Noh, PhD | Kolon TissueGene, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Kolon TissueGene, Inc. |
| ClinicalTrials.gov Identifier: | NCT03203330 |
| Other Study ID Numbers: |
TGC-12301 |
| First Posted: | June 29, 2017 Key Record Dates |
| Last Update Posted: | April 12, 2024 |
| Last Verified: | April 2024 |
| 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 |