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

General Information

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.
Clinical trials phase Phase 1
Start date (estimated) 2021-08-31
End date (estimated) 2027-12-31
Clinical feature
Label multiple sclerosis
Link http://purl.obolibrary.org/obo/DOID_2377
Description A demyelinating disease that involves damage to the fatty myelin sheaths around the axons of the brain and spinal cord resulting in demyelination and scarring.; OMIM mapping confirmed by DO. [LS].

Administrative Information

NCT number NCT04956744
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04956744
Other study identifiers
Name IMS001-01
Source weblink https://www.clinicaltrials.gov/ct2/show/study/NCT04956744
Regulatory body approval
Name Food and Drug Administration (FDA)
United States
Public contact
Email richard.kim@imstem.com
First name Richard
Last name Kim
Phone +1 860-281-7836
United States
Sponsors ImStem Biotechnology


Which differentiated cell type is used
Label mesenchymal stem cell
Link http://purl.obolibrary.org/obo/CL_0000134
Description A connective tissue cell that normally gives rise to other cells that are organized as three-dimensional masses. In humans, this cell type is CD73-positive, CD90-positive, CD105-positive, CD45-negative, CD34-negative, and MHCII-negative. They may further differentiate into osteoblasts, adipocytes, myocytes, neurons, or chondroblasts in vitro. Originally described as residing in the bone marrow, this cell type is now known to reside in many, if not all, adult organs.; Many but not all mesenchymal cells derive from the mesoderm. MSCs are reportedly CD3-negative, CD4-negative, CD5-negative, CD8-negative, CD11a-negative, CD11b-negative, CD14-negative, CD19-negative, CD29-positive, CD31-negative, CD34-negative, CD38-negative, CD40-negative, CD44-positive, CD45-negative, CD49-positive, CD54-positive, CD66b-negative, CD79a-negative, CD80-negative, CD102-positive, CD106-positive, CD117-positive, CD121a-positive, CD121b-positive, CD123-positive, CD124-positive, CD133-negative, CD146-positive, CD166-positive, CD271-positive, B220-negative, Gr1-negative, MHCI-positive, MHCII-negative, SSEA4-negative, sca1-positive, Ter119-negative, and glycophorin A-negative. Cultured MSCs are capable of producing stem cell factor, IL7, IL8, IL11, TGF-beta, cofilin, galectin-1, laminin-receptor 1, cyclophilin A, and MMP-2.


Recruitment Status Recruiting
Estimated number of participants 30