A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis
Phase 1
Recruiting
- Conditions
- Multiple Sclerosis
- Interventions
- Biological: IMS001
- Registration Number
- NCT04956744
- Lead Sponsor
- ImStem Biotechnology
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Low Dose IMS001 Low dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1. High Dose IMS001 High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1. Optional Dose IMS001 High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1 and at Month 6.
- Primary Outcome Measures
Name Time Method Safety and tolerability Day 1 to Month 60 Clinically significant laboratory abnormalities.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Shepherd Center
🇺🇸Atlanta, Georgia, United States
Rocky Mountain MS Clinic
🇺🇸Salt Lake City, Utah, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States