Evaluation of Safety and Exploratory Efficacy of PSC-01, an Autologous Adipose-derived Stromal Vascular Fraction Cell Therapy Product for the Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 1 期
- 入组人数
- 125
- 试验地点
- 7
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
The objective of this clinical study is to evaluate the safety of an intraarticular injection of an investigational biologic product (IBP), PSC-01, the patient's own adipose-derived stromal vascular fraction cells (SVF) extracted from a lipoaspirate sample, to treat the pain of osteoarthritis in a single knee. The secondary objective is to get initial data on efficacy of the PSC-01.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If a woman of childbearing potential, the study participant must not be pregnant at the time of consent and must take contraceptive measures to prevent a pregnancy while actively participating in the study
- •The study participant may be of any gender or ethnic background.
- •Must experience knee pain at least weekly for at least 3 months.
- •Must have failed a minimum of 6 weeks of first line, conservative therapy
- •Demonstrated clinical and radiographic evidence of OA diagnosis
- •Grade 2, 3, or 4 Kellgren-Lawrence score in one knee.
- •Normal or within protocol approved limits of laboratory blood and urinalysis tests
- •Must be suitable for cellular therapy per the Investigator's opinion
- •Must be suitable for liposuction per the Investigator's opinion
- •Must possess the cognitive ability to understand the investigational nature of this clinical trial and voluntarily provide consent for study participation
排除标准
- •Evidence of OA in the contralateral knee with a Kellgren-Lawrence score greater than 2
- •If a woman of child-bearing potential, the study participant must not be pregnant or attempt to become pregnant while actively taking part in the study.
- •Steroid injection in either knee within 60 days of providing informed consent
- •The subject must not be diagnosed with any of the following diseases at the time of consent:
- •Osteonecrosis
- •Active autoimmune disease
- •Serious cardiac condition
- •Psychotic Diseases
- •Uncontrolled diabetes
- •Prescribed immunosuppressive therapy at the time of consent
- •Evidence of cancer at the time of consent
- •History of alcohol or substance abuse
- •Regular smoker at the time of consent
- •Received experimental medication or participated in another clinical study within 60 days of providing informed consent
- •Concurrent diseases or circumstances that the Investigator judges to be a potential risk to patient health or a confounding variable in the assessment of study endpoints.
研究组 & 干预措施
PSC-01
All study participants will receive intraarticular injection of the investigational biological product, PSC-01.
干预措施: PSC-01 (Drug)
结局指标
主要结局
Incidence of Adverse Events
时间窗: 3-4 months
The primary outcome measure of this study is to evaluate the safety of the investigational biological product, PSC-01.Safety will be assessed as the number of treatment-related adverse events as assessed by CTCAE v5.0. Adverse events will be assessed by physical examination, patient-reported health status, clinical pathology evaluations (cbc, chemistry, and urinalysis), and post-procedure clinical observations through the 84-day study period with post-treatment follow-up at 6 and 12 months.
次要结局
- Changes in KOOS Measurement(3-4 months)