A Prospective, Non-randomized, Open Label Study to Assess the Safety and the Efficacy of Autologous Multipotent Mesenchymal Stem Cells in the Treatment of Amyotrophic Lateral Sclerosis. - AMSC in ALS

Bioinova, s.r.o.0 个研究点目标入组 30 人开始时间: 2011年4月5日最近更新: 2017年9月4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 definite ALS according to El Escorial kriteria and data available from detailed neurologic observation (including ALSFRS, Norris scale, spirometry, brain and spinal cord MRI) for at least 6 months prior to the study entrance,
•2.riluzole naive or at stable dose for at least 2 months,
•3.patients between 18–65 years, both sexes, life expectancy more than 2 years,
•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 30
•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 will be excluded from the participation in this study:
•1.FVC less than 70% ,
•2.in case of primary bulbar paralysis less than 15 points on Norris bulbar scale,
•3.less than 15 points on Norris spinal scale,
•4.pregnancy, breastfeeding
•5.coagulopathy,
•6.skin infection at the site of bone marrow aspiration or application of the cell product,
•7.gastrostomy,
•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, cancer, systemic infection, reccurent thromboembolic disease .....),
•9. alcohol or drug abuse,
•10. cancer,
•11. 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,
•12. fertile men not using proven contraceptive measures including effective contraception of their partner (established oral contraception, intrauterine device, ligation of the uterine tube).

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