NCT05789719尚未招募1 期
An Exploratory Clinical Study to Investigate the Effect of autoSTEM-OA and alloSTEM-OA in Participants With Knee Osteoarthritis.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- STEM-OA safety
研究概览
简要总结
A phase 1 exploratory clinical study to investigate safety, tolerance and efficacy of a single intra-articular injection of autoSTEM-OA or alloSTEM-OA in participants with mild to moderate knee osteoarthritis
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •Male or female, aged 18 - 60 years (both inclusive) at the time of informed consent.
- •Joint pain ≥ 30mm on 100mm VAS at screening
- •Grade 2-3 Kellgren Lawrence OA on radiograph with no full-thickness lesion >1 cm in any dimension by x-ray
- •Failure of minimum 2 nonoperative therapies (oral pain medications, physical therapy, corticosteroid injection, or viscosupplementation injection)
- •Body mass index (BMI) within the range 18 - 35 kg/m2 (both inclusive)
- •Minimum 200 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs as judged by the investigator.
- •Agree to donate cells to alloSTEM-OA participants.
- •Fulfils eligibility criteria for allogeneic cell- and tissue donors.
- •Speaks and reads Danish or English
排除标准
- •Active tobacco use, or use of other nicotine substitutes
- •Active cancer or still in follow-up (5 years)
- •Rheumatologic disease
- •Avascular disease
- •Severe bone deformity
- •Previous infection of the knee joint
- •Pes anserine bursitis
- •pain attributed to diffuse edema
- •pain attributed to displaced meniscal tear or osteochondritis
- •Neurogenic or vascular claudication
- •Bleeding disorders
- •Chemotherapy
- •Radiation therapy to the leg or adipose harvested site
- •Knee injections within 3 months of treatment
- •Unable to discontinue the following drugs 7 days before injections (prescription pain medication, anticoagulation medicine (including ibuprofen), thrombolytics, antiplatelet medication)
- •Use of oral glucocorticoids.
- •Female who is pregnant, breast-feeding or intends to become pregnant within 1-year after the treatment, or is of child-bearing potential and not using highly effective contraceptive method.
- •Known chronic disease associated with metabolism malfunction or poor healing.
- •Allergy towards necessary anaesthesia
- •Varus/valgus malalignment >5°
- •Isolated patellofemoral arthrosis
结局指标
主要结局
STEM-OA safety
时间窗: 13 weeks
Number of treatment emergent adverse events (TEAEs)
次要结局
- Knee pain(13 weks)
- Number of treatment responders(13 weks)
研究者
研究点 (2)
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