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)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 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
研究组 & 干预措施
Phase 2 Arm 5 - OA Shoulder
50 subjects receive two doses of 2.0-2.86 x 10^6 cells/kg on days 0 and 6 via intravenous infusion.
On day 3, each subject will receive a single dose of 1.0-2.86 x 10^6 cells/kg via intra-articular injection into the injured joint.
干预措施: Celltex- AdMSCs (Biological)
Phase 2 Arm 3 - OA Hip
50 subjects receive two doses of 2.0-2.86 x 10^6 cells/kg on days 0 and 6 via intravenous infusion.
On day 3, each subject will receive a single dose of 1.0-2.86 x 10^6 cells/kg via intra-articular injection into the injured joint.
干预措施: Celltex- AdMSCs (Biological)
Phase 2 Arm 6 - OA Shoulder
Control group- 50 subjects receive three doses of 2.0-2.86 x 10^6 cells/kg on day 0, 3, and 6 via intravenous infusion
干预措施: Celltex- AdMSCs (Biological)
Phase 2 Arm 4 - OA Hip
Control group- 50 subjects receive three doses of 2.0-2.86 x 10^6 cells/kg on day 0, 3, and 6 via intravenous infusion
干预措施: Celltex- AdMSCs (Biological)
Phase 2 Arm 2 OA Knee
Control group- 50 subjects receive three doses of 2.0-2.86 x 10^6 cells/kg on day 0, 3, and 6 via intravenous infusion
干预措施: Celltex- AdMSCs (Biological)
Phase 2 Arm 1 - OA Knee
50 subjects receive two doses of 2.0-2.86 x 10^6 cells/kg on days 0 and 6 via intravenous infusion.
On day 3, each subject will receive a single dose of 1.0-2.86 x 10^6 cells/kg via intra-articular injection into the injured joint.
干预措施: Celltex- AdMSCs (Biological)
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 Society Score (KSS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients(12 months)
- 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 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)