An Exploratory Clinical Study to Investigate the Effect of autoSTEM-OA and alloSTEM-OA in Participants With Knee Osteoarthritis.

StemMedical A/S1 个研究点分布在 1 个国家目标入组 20 人开始时间: 2023年11月1日最近更新: 2023年3月29日

适应症

干预措施

试验速览

阶段: 1 期
状态: 尚未招募
发起方: StemMedical A/S
入组人数: 20
试验地点: 1
主要终点: STEM-OA safety

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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