Safety and Biological Efficacy Study of TisssueGene-C to Degenerative Arthritis
A Dose-escalating, Single-center, Phase I Clinical Trial to Investigate the Safety and Biological Efficacy of TissueGene-C in Degenerative Arthritis Patients.
The primary purpose of the this study is to evaluate the safety of TissueGene-C, a gene therapy product that uses allogenic human chondrocytes expressing Transforming Growth Factor(TGF)-β1 by assessing the inflammation at the injection site, the incidence and severity of the adverse events, the physical examination findings, and the laboratory test results after the intra-articular injection of TissueGene-C.
And Secondary purpose is to evaluate the biological efficacy (knee pain, range of motion, functional tests, and MRI) of TissueGene-C and the distribution of TissueGene-C outside the injection site.
調査の概要
状態
条件
詳細な説明
TissueGene-C is a biological new drug which consists of normal chondrocyte cells and transduced chondrocyte cells that express growth factor to modify osteoarthritis symptom for long term period.
During clinical trial Phase 1, we compare three different dose levels of TisssueGene-C in 6 months with 12 outpatients with degenerative arthritis. The patients are randomized by three different dose levels of TisssueGene-C in 1:1:1 ratio, and they are monitored and recorded for alleviating symptoms, sports activities, function of the knee, and the presence of adverse events.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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-
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Seoul、大韓民国、135-710
- Samsung Medical Center
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male or female patients
- Patients aged 45 years or more with Grade IV [based on the International Cartilage Repair Society(ICRS) evaluation criteria from the MRI scan results] degenerative arthritis of the knee, whose symptoms had not been relieved by the conventional symptomatic treatment
- Healthy, with no major physical examination, hematology, serum chemistry, and urine test findings and no significant medical history
- Patients with cartilage damage sized 2-6 cm2 (based on the ICRS evaluation criteria from the MRI scan results)
- Voluntarily agreed to participate in this study and signed the informed consent form
Exclusion Criteria:
- Showed clinically significant hematology, serum chemistry, or urine test results at the screening visit
- Took an anti-inflammatory medication (prescribed or over-the-counter), including natural medicine, within 14 days from the administration of the investigational product
- Has a history of drug abuse within one year from the enrollment, or the urine test or blood alcohol test result was positive at the screening visit
- Received any injection in the target knee within two months before the initiation of the study
- Pregnant or breastfeeding female
- With another joint disease apart from degenerative arthritis (e.g., systemic rheumatic inflammatory disease associated with the knee or chondrocalcinosis, hemachromatosis, inflammatory arthritis, necrosis of the trochanter, Paget's disease adjacent to a joint in the femur or the tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's disease in the knee joint, villonodular synovitis, and synovial chondromas)
- With an infectious disease, including HIV or hepatitis (HBV/HCV)
With a history any of the following clinically significant diseases:
- heart disease [e.g., myocardial infarction, arrhythmia, other serious heart disease, coronary artery bypass graft (CABG)]
- kidney disease (e.g., chronic renal failure, glomerulonephritis)
- liver disease (e.g., liver cirrhosis, fatty liver, acute or chronic liver disease)
- endocrine disease (e.g., hyperthyroidism, hypothyroidism, thyroiditis, diabetes insipidus, Cushing's disease)
- insulin-dependent diabetes mellitus
medical history of or current malignant tumor In particular, the tumors that TissueGene-C may aggravate can be screened using the following tests
- Leukemia : White Blood Cell level in the hematology
- Osteochondroma, Chondromas, Chondroblastoma, Chondromyxoid fibroma, Chondrosarcoma : Alkaline phosphatase level in the hematology
- Participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study
- Showed positive drug test results at the screening visit
- Did not agree to use a contraceptive method (male and female)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：TissueGene-C(Low dose)
Single intra-articular injection to the damaged knee joint at doses of 3.0 x 10^6 cells
|
3.0 x 10^6 cells
|
|
実験的：TissueGene-C(Medium dose)
Single intra-articular injection to the damaged knee joint at doses of 1.0 x 10^7 cells
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1.0 x 10^7 cells
|
|
実験的：TissueGene-C(High dose)
Single intra-articular injection to the damaged knee joint at doses of 3.0 x 10^7 cells
|
3.0 x 10^7 cells
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants with Adverse Events after the administration of TissueGene-C
時間枠：6 months
|
Number of Participants with Adverse Events after the administration of TissueGene-C
|
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in MRI scan
時間枠：before and 28 days, 3 months, and 6 months
|
Change in the MRI scan results after the administration of TissueGene-C
|
before and 28 days, 3 months, and 6 months
|
|
Change in the Knee Society Clinical Rating System(KSCRS) test results
時間枠：before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
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Comparative Evaluation of knee exam
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before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
|
Changes in WOMAC scores
時間枠：before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities(WOMAC)
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before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
|
Changes in 100 mm-VAS
時間枠：before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)
|
before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
|
Analysis of the TGF-β1 expression using Enzyme-linked Immunosorbent Assay(ELISA) and Polymerase Chain Reaction(PCR)
時間枠：before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
Analysis of the TGF-β1 expression using Enzyme-linked Immunosorbent Assay(ELISA) and Polymerase Chain Reaction(PCR)
|
before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
|
Replication-competent retrovirus test (RCR test)
時間枠：before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
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Replication-competent retrovirus test (RCR test)
|
before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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