NCT04632966Unknown1 期
A Prospective, Open-Label, Dose-Escalation Phase 1 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Incidence of local and systemic treatment emergent adverse events (AEs) and incidence of abnormal laboratory and immunogenicity panels
研究概览
简要总结
Evaluation of safety, tolerability, and efficacy of a single intra-articular (IA) injection of PTP-001, an allogeneic placental tissue particulate, in individuals with knee osteoarthritis (OA).
详细描述
This open-label, dose-escalation study is expected to enroll 20 participants, 40-80 years of age and test two doses (low and high dose) of PTP-001, an allogeneic placental tissue particulate, in two unique cohorts of 10 participants each. Each participant will receive a single intra-articular (IA) injection of PTP-001. Following the completion of the first cohort in which 10 participants (Kellgren-Lawrence Grade 2 or 3 knee OA) will be treated with the low dose of PTP-001, safety data will be reviewed by an independent Data and Safety Monitoring Board (DSMB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent to participate in the study
- •Male or female, aged 40 to 80 years
- •Symptomatic knee OA with Kellgren-Lawrence radiographic classification of 2 or 3
- •Non-responsive after at least 3 months of conservative therapy for knee OA
- •Females of childbearing potential must have negative pregnancy test result prior to treatment and must commit to highly effective methods of contraception for at least 6 months after treatment
- •Willingness to report oral analgesic treatment used for knee pain and to discontinue analgesic treatment for knee pain in 24 hours prior to each study visit
- •Willingness to limit use of pain rescue medication to oral acetaminophen for management of painful knee OA flare
排除标准
- •Body mass index (BMI) ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with condition that warrants weight loss surgery
- •Presence of active infection of index knee or systemic infection requiring treatment within 3 months of Screening
- •Administration of IA injection within 3 months of Screening
- •Significant acute injury to index knee within 3 months of Screening
- •Surgery to index knee within 6 months of Screening or planned surgery to index knee within 6 months after Screening
- •Unstable index knee joint
- •History of radiation therapy of index knee
- •Known vascular or neurological disorder affecting the index knee
- •Osteonecrosis of either knee
- •Clinical diagnosis of inflammatory arthritis
- •Clinical diagnosis of autoimmune disease affecting the musculoskeletal system
- •Use of any other investigational therapy within 3 months of Screening or planned for the duration of the study
- •Current anti-coagulant use
- •History of receiving a solid organ or hematologic transplant
- •History of malignancy or radiotherapy within 5 years of Screening, except for basal or squamous cell carcinoma of the skin
- •Use of immunosuppressive or chemotherapeutic agents within 5 years of Screening
- •Known allergy to local anesthetics or allograft tissues
- •Known history of hepatitis
- •Known history of thrombotic or thromboembolic phenomena.
- •Known history of primary or secondary immunodeficiency disorders
- •Presence of concurrent medical condition that, in the investigator's judgement, could compromise participant safety or interfere with the required study assessments and study participation.
- •Note: Other protocol defined inclusion/exclusion criteria apply.
结局指标
主要结局
Incidence of local and systemic treatment emergent adverse events (AEs) and incidence of abnormal laboratory and immunogenicity panels
时间窗: Baseline to Week 52
Incidence of local and systemic treatment emergent adverse events (AEs), including clinical laboratory and immunogenicity panels, after a single intra-articular injection of PTP-001.
次要结局
- Western Ontario and McMaster University (WOMAC) Pain Responder Rate(Week 26 and Week 52)
- WOMAC Physical Function Responder Rate(Week 26 and Week 52)
- Change from baseline in patient global assessment of OA, by assessing the participants assessment of how they are doing considering arthritis in index knee (the possible answers include "Very Good", "Good", "Acceptable", "Poor", "Very Poor"(Baseline to Week 52)
- Change from baseline in physical function of the index knee, by evaluating the WOMAC Physical Function subscale score (the possible total score ranging from 0-170 for Physical Function)(Baseline to Week 52)
- Change from baseline in health-related quality of life, by assessing the items from the Short Form 36 (SF-36) survey(Baseline to Week 52)
- Change from baseline in pain of the index knee, by evaluating the WOMAC Pain subscale score (the possible total score ranging from 0-50 for pain)(Baseline to Week 52)
研究者
研究点 (4)
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