NCT03602872撤回1 期
Phase I, Open Label Study to Assess the Safety and Tolerance of a Single Intraarticular Dose of STEMEDICA's Human Allogeneic Bone Marrow Derived Mesenchymal Stem Cells, in Subjects With Knee Osteoarthritis.
Clinica Santa Clarita, Mexico2 个研究点 分布在 1 个国家开始时间: 2019年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Safety evaluation of all AE/SAEs
研究概览
简要总结
The aim of this study is to assess the safety of Stemedica's mesenchymal stem cells in patients with knee osteoarthritis. The route of administration is intraarticular. Safety will be evaluated by AE/SAE incidence and administration tolerance. The subjects will undergo follow-up for 52 weeks. The target population is subjects with knee osteoarthritis (grade II-III in Kellgren-Lawrence scale).
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female volunteers between 35-65 years.
- •X-ray evidence of osteoarthritis (grade II-III in Kellgren-Lawrence).
- •Chronic joint pain (>5 visual analogue scale) in knee.
- •Voluntary acceptance and signature of informed consent.
- •Willing to attend study visits and lab sample recollection.
- •Lab values within normal reference values.
- •Willing to use effective birth control methods.
排除标准
- •Inflammatory arthritis.
- •Generalized infection.
- •Active cancer or history of cancer in the past 5 years.
- •Receiving oral or intraarticular steroids.
- •Positive labs for HIV, Hepatitis B or C.
- •Recent trauma in the target joint.
- •Debris in joint.
- •Subjects that have undergone or need to undergo arthroscopic knee surgery in the target joint.
- •History of joint substitution, intraarticular fractures, osteotomy, arthroplasty or menisectomy.
- •Clinically significant knee misalignment.
- •Other illnesses that the investigator considers clinically significant.
- •Participating in another clinical trial three months before enrolling.
- •Women that are pregnant, lactating or result positive in the pregnancy test during screening.
- •Known allergies to bovine products.
- •Subjects taking anticoagulants.
结局指标
主要结局
Safety evaluation of all AE/SAEs
时间窗: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject
All AE/SAE will be assessed for causality and reported utilizing MedDRA terminology.
次要结局
- OAKHQOL questionnaire(From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject)
- WOMAC questionnaire(From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject)
- Procedure tolerance (procedure pain/discomfort incidence)(7 days after subject receives dosing)
研究者
研究点 (2)
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