Clinical trial NCT04956744: A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis
Official title: A Phase 1, Dose-Escalating, Open-label Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of Single Dose of IV IMS001 in Subjects With Multiple Sclerosis and Treatment Failure to Prior Disease Modifying Treatments (DMTs)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Multiple Sclerosis
Lead sponsor: ImStem Biotechnology
Sponsor class: INDUSTRY
Collaborators: name: Rho, Inc.
First posted: 2021-07-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Safety and tolerability
timeFrame: Day 1 to Month 60
measure: Safety and tolerability
timeFrame: Day 1 to Month 60
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Salt Lake City
country: United States
facility: Rocky Mountain MS Clinic
state: Utah
Study officials:
affiliation: ImStem Biotechnology
name: Richard Kim, MD
role: STUDY_DIRECTOR
References: