The evaluation of the effect of Wharton’s Jelly Mesenchymal Stem Cells (WJMSCs) on the immune system of patients with Amyotrophic Lateral Sclerosis (ALS) - ALSTEM

Polski Bank Komórek Macierzystych JSC (PBKM)0 个研究点目标入组 20 人开始时间: 2019年9月5日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•1.Adult patients (at least 18 years old)
•2. The minimum patient's weight is not less then 40 kg.
•3.Diagnosis of sporadic ALS, definite or probable, as defined by El Escorial World Federation of Neurology criteria
•4.History of ALS symptoms less than 2 years duration from the first symptoms of the disease
•5.More than 6 months from diagnosis of the disease
•6.Disease progression at 6 past months at least 3 points during this period of time
•7.ALSFRS-R scale of at least 30 at screening appointment
•8.Forced vital capacity >70% of predicted value for age, gender and height
•9.Treatment with stable dose of riluzole before baseline visit (for at least 1 month)
•10.Capable of providing written informed consent
•11.Able to comply with study requirements and willing to follow all study procedures and follow-up visits
•12.Women of child-bearing age and men with partners of child-bearing potential must agree to use two forms of contraceptive therapy throughout the course of the trial
•13.Women of child–bearing age must undergo pregnancy test
•14.Polish-language native speakers or patients who are proficient in the Polish language
•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) yes
•F.1.3.1 Number of subjects for this age range 20

•1.Pregnancy or breastfeeding
•2.Tracheostomy
•3.Ventilator dependence
•4.Renal disease with creatinine >2mg/dl
•5.Liver disease with ALT, AST or GGTP 2-fold higher than upper normal limit
•6.Positive test for HBV, HCV, HIV with NAT method
•7.Positive tests for syphilis
•8.Any other clinically significant abnormalities on laboratory evaluation
•9.Any condition that would compromise ability of undergoing lumbar puncture
•10.Active systemic disease
•11.Autoimmune disease (Hashimoto disease under control is allowed)
•12.Uncontrolled diabetes
•13.Pulmonary disease that could affect interpretation of spirometry
•14.Neurological concomitant disease
•15.Unstable psychiatric concomitant disease
•16.High risk of suicide
•17.History of substance abuse within past year
•18.History of malignancy, within the previous 5 years, including melanoma with exception of localized skin cancers
•19.Any other clinically significant medical condition that can compromise patient’s safety in the opinion of the investigator
•20.Treatment with immunomodulatory drugs (for example immunoglobulins, corticosteroids or other immunosuppressant) in last 6 months
•21.Participation in another clinical trial in last 6 months
•22.Previous cellular therapy of any kind
•23.Hypersensitivity to any component used in the cell culture
•24.Nuchal rigidity and other signs of meningitis
•25.Patients on chronic anticoagulation treatment (heparin/ warfarin/acenocumarol/(N)OAC)

发起方

Polski Bank Komórek Macierzystych JSC (PBKM)