Active, not recruiting
Phase 1
A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis
Condition(s) studied
Multiple Sclerosis
Investigational drug(s) / intervention(s)
IMS001
IMS001: IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC).
Study 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
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 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.
Primary outcome measure(s)
- Safety and tolerability — Day 1 to Month 60
Frequency of treatment-emergent adverse events (TEAEs).
- Safety and tolerability — Day 1 to Month 60
Clinically significant laboratory abnormalities.
Trial sites (3)
| Facility | City | Region | Status |
| Shepherd Center |
Atlanta |
Georgia |
|
| UMass Memorial Medical Center |
Worcester |
Massachusetts |
|
| Rocky Mountain MS Clinic |
Salt Lake City |
Utah |
|
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