Innovation of method cryopreservation for clinical use autologous multipotent mesenchymal stem cells (MSCs) for treatment of extensive skeletal defects in revision surgery of total hip arthroplasty+ - Method of cryopreservation autologous multipotent mesenchymal stem cells (MSCs)

Fakultní nemocnice Hradec Králové0 个研究点目标入组 6 人开始时间: 2016年6月6日最近更新: 2024年7月29日

适应症

试验速览

暂无简介。

•To participate in this trial, patients have to meet following criteria:
•1. Established diagnosis of aseptic loosening of a total hip arthoplasty indicated for revision hip surgery;
•2. Subjects with extensive femoral bone defects;
•3. Age between 18-75 years, both sexes, and
•- for subjects aged 18 to 65 years: ASA score I to III
•- for subjects aged 66 to 75 years: ASA score I to II
•4. Able to provide written informed consent
•(ASA score: A physical status classification systém of the American Society of Anesthesiologist for assessing the fitnes of patients befor surgery)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 4
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•Patients meeting any of the following criteria shall not be allowed to principate in thos study:
•1. Previous infection at the site of total hip arthroplasty
•2. Rheumatoid arthritis
•3. Pregnancy or breastfeeding
•4. Women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube)
•including proven contaceptive measures taken by their sexual partners
•5. fertile men not using proven contraceptive measures including effective contraception method (established oral contraception, intrauterine device,
•ligation of the uterine tube) in their partner
•6. skin infection at the site of bone marrow aspiration or at the site of total hip arthroplasty
•7. malnutrition, primary biliar cirrhosis
•8. any significant medical condition that would compromise the safety of the patient (e.g. recent myocardial infarction, congestive heart failure,
•renal failure, liver failure, systemic infection, ...)
•9. alcohol or drug abuse
•10. cancer (compulsory clinical oncological screening)
•11. osteonecrosis of pelvis and hip due to past radiation treatment
•12. ongoing and recent (last 3 months) systemic corticosteroid or immunosuppressive therapy

发起方