A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis

Eligibility Criteria

• * Provides signed and dated informed consent in accordance with local regulations.
• * 18 to 65 years of age.
• * Diagnosis of MS.
• * Has had an inadequate response DMTs.
• * EDSS within protocol parameters.
• * Able and willing to undergo MRIs.
• * Must be clinically stable for 1 month prior to Day 1.
• * Has a known or suspected hypersensitivity to human serum albumin, diphenhydramine, acetaminophen, methylprednisolone, or any of the components of IMS001.
• * Has history of excluded medications, per protocol, prior to Day 1.
• * Has a history of neoplastic disease except for basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin that has been excised with clean margins, or adequately treated in-situ carcinoma of the cervix.
• * Prior history of any other autoimmune disease, myelodysplasia, or hematologic disease.
• * Prior treatment with any allogeneic cell therapy or tissue transplant.
• * Prior history of smoking equivalent to ˃20 cumulative pack years of cigarettes.
• * Recent clinically significant infection during the Screening Phase.
• * Has any medical or psychiatric condition that would impact outcome or participation in the study.
• * Has clinically significant abnormal findings on the electrocardiogram (ECG) during the Screening Phase.
• * Has known or documented human immunodeficiency virus (HIV) infection or active Hepatitis B, or C.
• * Has an elevated liver function test abnormality during the Screening Phase.
• * Has abnormalities of blood count during the Screening Phase.
• * Has laboratory abnormalities of renal function during the Screening Phase.
• * Has other clinically significant laboratory abnormalities during Screening Phase.
• * Body weight ≥120 kg.
• * Women pregnant, breast feeding, or planning to become pregnant during the study.
• * Is unavailable for the duration of the trial, is likely to be noncompliant with the protocol, or is generally felt to be unsuitable by the principal investigator.
• * Current or recent participation in any other clinical or device trials within 3 months prior to Day 1.