Multiple Sclerosis
Conditions
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.
Interventions
BIOLOGICALIMS001
IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC).
Sponsors
ImStem Biotechnology
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | Day 1 to Month 60 | Frequency of treatment-emergent adverse events (TEAEs). |
Countries
United States
Contacts
STUDY_DIRECTORRichard Kim, MD
ImStem Biotechnology
Outcome results
None listed