NCT06485843招募中2 期
An Open Label Phase IIb Study to Evaluate Safety and Tolerability of OA-SYS in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint
Ageless Biotech, Inc.1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年5月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Presence of Adverse Events
研究概览
简要总结
This study is being conducted to evaluate the safety and tolerability of OA-SYS in patients with moderate to severe OA of the knee joint.
详细描述
PURPOSE OF THE STUDY The goal of this clinical trial is to evaluate the safety and tolerability of a treatment called OA-SYS for moderate to severe osteoarthritis (OA) of the knee. Osteoarthritis is a common condition that affects the joints and can cause significant pain and disability, especially in older adults. The study aims to see if OA-SYS is a safe and effective treatment option for people with knee osteoarthritis.
STUDY TREATMENT
Participants in this study will receive the OA-SYS treatment, which involves the use of adult stem cells (ASCs). The main questions the study aims to answer are:
- Is OA-SYS safe and well-tolerated by participants with moderate to severe knee osteoarthritis?
- Does OA-SYS help reduce the symptoms and improve the function of the knee joint?
Participants will:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between the ages of 35 - 75 years Body Mass Index (BMI) less than 39 kg/m2
- •Ambulatory and in good general health
- •Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions
- •Willing to abstain from use of protocol-restricted treatments from Screening through End-of-Treatment
- •Kellgren-Lawrence grading scale score of 3 or 4 for OA of the knee
- •No clinically significant abnormalities observed in medical history, physical exam vital signs, and laboratory assessments
- •For females of reproductive potential: use of effective contraception for at least 1 month prior to screening and agreement to use such a method till end of the study period and negative pregnancy test
- •For males of reproductive potential: use of condoms and other methods to ensure effective contraception
排除标准
- •Known or suspected infection of the target joint
- •Subjects with surgery for OA in the target joint
- •Subject with reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
- •Subject with myocardial infarction, congestive heart failure, and other severe heart disease or hypertension (or medical history of hypertension) that are not controlled below 140/90 mmHg even with treatment with more than three antihypertensive drugs
- •Subject with serious medical conditions other than cardiovascular disease
- •Subject with, or with a medical history of autoimmune diseases
- •Subject with an infection that requires parenteral antibiotic administration within 30 days prior to screening
- •Subject with a medical history of mental disorder or epilepsy
- •Subject abuse alcohol 10 times a week or smoke 25 cigarettes a day
- •Subject who was diagnosed with cancer within 5 years before screening
- •Subject who participated in another clinical trial within 6 months prior to the screening of this clinical trial
- •Subject who was administered with immunosuppressants such as cyclosporin A or azathioprine within 6 weeks prior to the screening
- •Subject who had intra-articular administration such as sodium hyaluronate injections within 6 months prior to the screening
- •Clinical findings consistent with active infection or crystal disease in the index joint within 1 month prior to the screening
- •History of fracture in the index limb or fracture with sequelae within 12 months prior to the screening
- •Joint instability or history of acute dislocation within 12 months prior to the screening
- •Planned or anticipated surgery of the joint during the study period
- •Presence of surgical hardware or other foreign body in the index joint
- •Surgery or arthroscopy of the index joint within 12 months of screening
- •Intra-articular treatment of any joint with any of the following agents within 6 months prior to the screening: Any corticosteroid preparation (investigational or marketed), any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection)
- •Treatment of the index joint with any investigational therapy within 6 months prior to the screening
- •Serious life-threatening conditions
- •Allergies to anesthesia
- •Subject who is breastfeeding.
研究组 & 干预措施
OA-SYS
Experimental
Treatment with OA-SYS
干预措施: OA-SYS (Drug)
结局指标
主要结局
Presence of Adverse Events
时间窗: 52 weeks
Presence of adverse events in less than 5% of the study population, as a measure of safety
次要结局
- Change in NSAIDs Use(52 weeks)
- Change in The Western Ontario and McMaster Universities Arthritis Index (WOMAC)(52 weeks)
- Change in the Visual Analog Scale (VAS)(52 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Study of the Safety and Biologic Activity of AL01211 in Treatment Naive Males With Classic Fabry DiseaseFabry DiseaseNCT06114329AceLink Therapeutics, Inc.16
Unknown
1 期
A Phase 1/2 Study of BPI-361175 in Subjects With Advanced Solid TumorsNon-small Cell Lung CancerNCT05329298Betta Pharmaceuticals Co., Ltd.90
终止
2 期
A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of External Genital WartsCondylomata AcuminataNCT03158974ViroXis Corporation12
已完成
1 期
Low-Dose Ketamine in Children With ADNP SyndromeADNP SyndromeNCT04388774Alexander Kolevzon10
已完成
不适用
The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FAST PV and mGFR Technology™Kidney DiseasesRenal Insufficiency, ChronicUrologic DiseasesAcute Kidney InjuryRenal InsufficiencyNCT03095391FAST BioMedical32