A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis
Trial Parameters
Brief Summary
This is a Phase 1 study of IMS001, given as a single dose to subjects with Multiple Sclerosis who experience inadequate response and/or intolerability to disease modifying treatments. IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC). MSCs have the potential to modulate disease course.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: * 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