Study of Mesenchymal Autologous Stem Cells as Regenerative Treatment for Multiple Sclerosis (NCT04749667) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study of Mesenchymal Autologous Stem Cells as Regenerative Treatment for Multiple Sclerosis
Norway18 participantsStarted 2021-08-09
Plain-language summary
The primary objective of the study is to investigate neuroregenerative efficacy (proof of concept) of intrathecal treatment with autologous MSCs as measured by neurophysiological parameters in patients with progressive MS.
Secondary objectives are to assess neuroregenerative efficacy as measured by other neurophysiological parameters as well as clinical, opthalmological and MRI modalities, and to assess safety of the treatment procedure.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕. 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
✕. Current immunomodulatory/immunosuppressive 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