NCT04448106尚未招募2 期
Clinical Study for Subjects With Osteoarthritis of Knees, Hips, and Shoulders Using a Combination of Intravenous Infusions With Intra-articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Any organ damage or safety concerns determined by SMAC 20 blood test.
研究概览
简要总结
This is a phase 2 open-label, 6 arms (1 study group and 1 control group for each joint category), randomized control group clinical study with 300 subjects diagnosed with osteoarthritis of knees (n=100), hips (n=100) and shoulders (n=100). The study subjects will be evaluated for disease-associated severity according to symptoms, such as pain, mobility, daily active life, and functions using arthritis society established specific measurement tools related to the joints (KOOS and KSS for OA-knees: HOOS and HHS for OA-hips and ASES and CSS for OA-shoulders).
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and evaluators
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years
- •Male or female
- •Subjects in study group must have banked AdMSCs at Celltex (already passed communicable disease screen tests for HIV, syphilis and Hepatitis B and C during banking stage)
- •Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures
- •Must be diagnosed as OA-knees, OA-hips, or OA-shoulders by radiographic criteria and physical examination.
排除标准
- •Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start
- •Unwillingness or inability to comply with study procedures
- •Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.
- •Clinically active malignant disease
- •Previous thrombotic disorder
- •History of known pulmonary embolism or known secondary anti-phospholipid syndrome
- •Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur-containing products (e.g., DMSO)
- •Major trauma or surgery within 14 days of study treatment start
- •Mental condition rendering the subject (or the subject's legally acceptable representative[s]) unable to understand the nature, scope and possible consequences of the study
- •Alcohol, drug, or medication abuse within one year prior to study treatment start
- •Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study
- •Irreversible severe end-organ failure, such as heart failure/attack, stroke, liver and renal failure due to other disease conditions
- •Patients or family history with a hypercoagulable status, such as protein C/protein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.
- •History of long-term use of immunosuppressive agents
- •Organ transplants in the previous 6 months
- •Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study duration, unless surgically sterilized or postmenopausal during the study
结局指标
主要结局
Any organ damage or safety concerns determined by SMAC 20 blood test.
时间窗: 12 months
Safety
the frequency and nature of adverse events occurring during the study based on the annualized rate of all AdMSC-associated adverse events (AEs) in all subjects.
时间窗: 12 months
safety
次要结局
- Change of Knee injury and Osteoarthritis Outcome Score (KOOS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients(12 months)
- Change of Harris Hip Score (HHS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients(12 months)
- Change of Constant shoulder score (CSS, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients(12 months)
- Change of the American Shoulder and Elbow Surgeons Shoulder Score (ASES, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients(12 month)
- changes in joint images (X-ray or MRI) from the baseline(12 months)
- Change of Knee Society Score (KSS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients(12 months)
- Change of Hip disability and Osteoarthritis Outcome Score (HOOS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients(12 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Safety and Efficacy of JointAlive™ on the Knee-joint Function in Adults With Knee ArthritisOsteo Arthritis KneeNCT04395547Chenland Nutritionals Inc.72
终止
4 期
Lidocaine Patch Versus Celecoxib in Pain From Osteoarthritis of the KneeOsteoarthritis of the KneeNCT00904605Endo Pharmaceuticals
已完成
2 期
Pilot Study of Lidocaine 5% Patch Versus Placebo in Patients With Osteoarthritis Pain of the KneeOsteoarthritis, KneeNCT00904462Endo Pharmaceuticals224
Unknown
2 期
Phase 2B Clinical Study of Chondrogen for Treatment of Knee OsteoarthritisOsteoarthritis, KneeNCT04520945Meluha Life Sciences SDN BHD100
已完成
2 期
NGA-01 Gel for the Treatment of Osteoarthritis With Joint PainArthritis OsteoarthritisNCT04612283Nutrin GmbH60