Study of Mesenchymal Autologous Stem Cells as Regenerative Treatment for Multiple Sclerosis

Korábbi kezelés

• Any illness or prior/ongoing treatment that in the opinion of the investigators would jeopardize the ability of the patient to tolerate autologous stem cell treatment
• Immunomodulatory/immunosuppressive treatment within 6 months prior to inclusion. This includes, but is not restricted to treatment with natalizumab, fingolimod, dimetylfumurat, glatiramer acetate, interferon beta medications, teriflunomide, and siponimod.
• Treatment with kladribin, ocrelizumab, rituximab, and alemtuzumab within 12 months prior to inclusion
• Treatment with hematopoietic stem cell therapy within 12 months prior to inclusion
• Treatment with glucocorticoids or ACTH within three months prior to start of inclusion
• Having experienced an MS relapse within 2 years prior to study inclusion
• Current treatment with fampridin
• Prior or current major depression
• Prior or current psychiatric illness, mental deficiency or cognitive dysfunction influencing the patient ability to make an informed consent or comply with the treatment and follow-up phases of this protocol.
• Prior or current alcohol or drug dependencies

Más betegség

• Any ongoing infection, including Tbc, CMV, EBV, HSV, VZV, hepatitis virus, toxoplasmosis, HIV or syphilis infections, as well as heaptitis B surface antigen positivity and/or hepatitis C PCR positivity
• History of malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year
• Severely limited life expectancy by another co-morbid illness
• Estimated glomerular filtration rate \<60 ml/min/1.73 m2 or known renal failure
• Bleeding or clotting diathesis or the use of antithrombotic or anticoagulative treatment
• History of autologous/allogenic bone marrow transplantation or peripheral blood cell transplant
• Known hypersensitivity against paracetamol, codein or xylocain

Laborértékek

• History of previous diagnosis of myelodysplasia or previous hematologic disease (including lymphoproliferative disease, bone marrow insufficiency or previous lymphoid irradiation) or current clinically relevant abnormalities of white blood cell counts
• Platelet (thrombocyte) count \<100 x 10\*9/L

Egyéb

• Current immunomodulatory/immunosuppressive treatment
• Immunocompromised patients
• Participation in another experimental clinical study within the preceding 12 months
• Contraindications to MRI
• Pregnancy or risk of pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study), breastfeeding or lactation
• Diagnosis or strong suspicion of polyneuropathy
• Inability to give informed consent

• Age ≥18 to ≤55, both genders
• Diagnosis of secondary progressive or primary progressive MS using revised McDonald criteria of clinically definite MS
• An EDSS score of 4 to 7
• Disease duration 2 - 15 years
• Signed, written informed consent