Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients

Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients along with a supervised physical therapy program

Supervised physical therapy program without stem cells

Allogenic umbilical cord derived stem cells which are to be injected intrathecally as a treatment option for consenting MS patients

To isolate stem cells from UC: first, the cord will be cut into small pieces around (4-5cm) and washed with phosphate buffered saline, then the umbilical vein and the two arteries will be removed.These pieces will be placed in culture plate and cultured in UC-MSCs medium consist of; alpha modification of Minimum Essential Medium (α-MEM) supplemented with 10% fetal bovine serum, 1% glutamine, 1% penicillin/streptomycin and 1 μg/mL amphotericin B.After incubation period the undigested tissue will be discarded and nucleated cells will be pelleted by centrifugation at 450xg for 10 minutes. Cell pellet will be re-suspended in UC-MSCs culture medium, cultured in tissue culture flasks and placed in CO2 incubator at 37°C, 5% CO2. Cells will be expanded in multilayer cell factory tissue culture flasks to reach an estimated 108 UC-MSCs that will be frozen in bags of 106 cells for subsequent thawing and administration.

Outcome measures will be assessed at 3 months pre-treatment, baseline (prior injections), 3 months, 6 months, and 12 months.

Informed consent will be obtained in writing from each subject prior to participation in the study. If the subject is unable to give consent or he/she scores less than 24 on the Mini Mental Status Examination (MMSE), they will be excluded from the study. The research personnel involved in the study will carefully explain the consent form to the subject. The subject will then be given ample opportunity to ask questions prior agreeing to participate. If the need arises the research personnel will be available to answer questions and address any concerns.