A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis
Purpose
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.
Condition
- Multiple Sclerosis
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Low Dose |
Low dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1. |
|
|
Experimental High Dose |
High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1. |
|
|
Experimental Optional Dose |
High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1 and at Month 6. |
|
Recruiting Locations
UMass Memorial Medical Center
Worcester, Massachusetts 01605
Worcester, Massachusetts 01605
More Details
- Status
- Recruiting
- Sponsor
- ImStem Biotechnology