tilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease: a Prospective, Non-randomized, Open-Label Study to Assess the Safety and the Efficacy. - Autologous MCS effect in union of vertebrae after spinal surgery.

Bioinova, s.r.o.0 个研究点开始时间: 2013年3月20日最近更新: 2017年10月2日

适应症

试验速览

暂无简介。

•To participate in this trial, patients will have to meet following criteria:
•1. established diagnosis of spinal degenerative disease indicated for lumbar spine surgery,
•2. patients indicated for fusion therapy,
•3. patients between 18–55 years, both sexes,
•4. patients able to provide written informed consent.
•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 20
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patients meeting any of the following criteria shall not be allowed to participate in this study:
•1. previous lumbar spine surgery,
•2. osteoporosis,
•3. diabetes mellitus,
•4. pregnancy or breastfeeding,
•5. women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contraceptive measures taken by their sexual partners,
•6. fertile men not using proven contraceptive measures including effective contraception method (established oral contraception, intrauterine device, ligation of the uterine tube) in their partner,
•7. coagulopathy,
•8. malnutrition, primary biliar cirrhosis
•9. skin infection at the site of bone marrow aspiration or at the site of spinal fusion,
•10. gastrostomy,
•11. 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, reccurent thromboembolic disease .....),
•12. alcohol or drug abuse,
•13. cancer (compulsory clinical oncological screening),
•14. ongoing and recent (last 3 months) systemic corticosteroid or immunosuppressive therapy.

发起方