NCT01221441已完成2 期
A Phase II Study to Determine the Efficacy and Safety of Allogeneic Human Chondrocytes Expressing TGF-β1 (TissueGene-C) in Patients With Grade 3 Chronic Degenerative Joint Disease of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 5
- 主要终点
- Change From Baseline in the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 1 Year
研究概览
简要总结
The purpose of this study is to see if we can safely regenerate cartilage without invasive surgery using a biologic product called TissueGene-C.
详细描述
Protocol TGC09201 is a multi-center, double-blind, placebo-controlled, randomized study. A total of one hundred (100) adults with grade 3 chronic degenerative joint disease (DJD) of the knee joint (as determined by radiographic examination) will be enrolled into the study. TissueGene-C will be administered intra-articularly once via x-ray guidance. TissueGene-C will be administered at a dose of 3 x 10e7 cells. Patients receiving control treatment will receive a single normal saline injection.
The objectives of this study are to:
- Evaluate the efficacy of TissueGene-C with regard to knee functionality and symptoms of knee osteoarthritis including pain.
- Evaluate the safety of administration of a single intra-articular dose of TissueGene-C as evidenced by observation of the injection site for irritation or other abnormalities, the incidence and severity of adverse events, and the changes in physical examination findings and laboratory tests, including immune analyses.
- Evaluate the incidence and dose of analgesia and/or anti-inflammatory medication.
- Evaluate the regeneration of hyaline cartilage as determined by 3T magnetic resonance imaging (MRI).
- Evaluate distribution of hChonJb#7 cells out of the injection site.
- Evaluate the efficacy of TissueGene-C by evaluating the need for total knee arthroplasty after treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female subject
- •Age 18 to 70 years
- •In general good health as evidenced by physical examination, normal hematology, serum chemistry, and urinalysis screening laboratory results, and a negative history of significant organ system disorders. All laboratory values must be within 20% of normal ranges.
- •Body Mass Index (BMI) should be between '18.5 - 45.5'. The applied scale is the same for both men and women.
- •Blood Pressure measurements - Systolic Blood Pressure should be between 90-160mm. Hg, and Diastolic Blood Pressure between 50-90mm.Hg,
- •Patients with Grade 3 chronic osteoarthritis of the knee as determined by the Radiographic Criteria of Kellgren and Lawrence.
- •Symptom of pain for more than four (4) consecutive months and intensity of ≥ 40 and ≤ 90 on the 100-mm scale.
- •Patients should be cleared to use protocol specified equipment: 3T MRI.
- •Patients providing written informed consent after the nature of the study is fully explained and understood by the patient.
排除标准
- •Age 71 or older
- •Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results.
- •Patients taking non-steroidal anti-inflammatory medications within 14 days of baseline visit unless washed out as per section 3.6.4 above.
- •Patients taking steroidal anti-inflammatory medications within 2 months of baseline visit.
- •Patients with a recent (within 1 year) history of drug abuse and/or a positive urine drug test at the time of screening.
- •Patients receiving injections to the treated knee within 2 months prior to study entry
- •Patients who are contraindicated for 3T MRI.
- •Patients who are pregnant or currently breast-feeding children.
- •Patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, necrosis of the femoral condyle, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, synovial chondromatosis, and/or history of inflammatory arthropathy.
- •Patients with ongoing infectious disease, including HIV and hepatitis B or C.
- •Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or Type I diabetes.
- •Patients participating in a study of an experimental drug or medical device within 30 days of study entry.
- •Patients that will be unable to comply with the requisite study follow-up and are not able to complete all of the follow-up office visits and 3T MRI exams.
研究组 & 干预措施
TissueGene-C
Experimental
TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
干预措施: TissueGene-C (Biological)
Placebo Control
Placebo Comparator
Normal Saline injection
干预措施: Normal Saline (Drug)
结局指标
主要结局
Change From Baseline in the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 1 Year
时间窗: 1 Year
Symptoms, pain and function of the knee joint determined and scored using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation (Total Score, range 0-100 with higher scores better). Linear mixed model used for analysis.
Change From Baseline in Visual Analog Scale (VAS) Score at 1 Year
时间窗: 1 Year
Reduction in pain as measured by a 100 mm visual analog scale (0= no pain; 100 = extreme pain) from Baseline to 1 Year. Linear mixed model used for analysis.
次要结局
- Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 Years(2 Years)
- Change From Baseline in Articular Cartilage Damage in the Knee as Determined by the Lysholm Knee Score at 2 Years(2 Years)
- Comparative Evaluation of Knee Magnetic Resonance Images (MRIs) From Baseline to 1 Year(1 Year)
- Change in Pain Severity From Baseline to 2 Years as Assessed by Questionnaire(2 Years)
- Number of Participants With Change in Pain Severity Measured by Incidence and Dose of Analgesia(2 Years)
- Change From Baseline in Knee Function as Determined by the Lower Extremity Functional Scale at 2 Years(2 Years)
- The Incidence of Total Knee Arthroplasty(2 Years)
- The Number of Patients Experiencing Injection Site Reactions Related to Treatment(2 Years)
- The Incidence and Severity of Adverse Events in Treated Patients(2 Years)
- Number of Participants With Adverse Events Due to Clinically Significant Changes in Hematology and Urinalysis Tests(2 Years)
- Change in SF-36 General Health Assessment Questionnaire (Overall Score) From Baseline to 2 Years(2 Years)
研究者
研究点 (5)
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