A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis (NCT04956744)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (19 items).
Location: Shepherd Center โ Atlanta, Georgia
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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 ห20 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.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (3 Sites)
- Shepherd Center โ Atlanta, Georgia
- UMass Memorial Medical Center โ Worcester, Massachusetts
- Rocky Mountain MS Clinic โ Salt Lake City, Utah
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.