A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis
NCT ID: NCT04956744
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2021-08-31
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Low Dose
Low dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1.
IMS001
IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC).
High Dose
High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1.
IMS001
IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC).
Optional Dose
High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1 and at Month 6.
IMS001
IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC).
Interventions
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IMS001
IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC).
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Rho, Inc.
INDUSTRY
ImStem Biotechnology
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Kim, MD
Role: STUDY_DIRECTOR
ImStem Biotechnology
Locations
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Shepherd Center
Atlanta, Georgia, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Rocky Mountain MS Clinic
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Related Links
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Imstem Biotechnology
Other Identifiers
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IMS001-01
Identifier Type: -
Identifier Source: org_study_id
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