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A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT04956744
Recruitment Status : Recruiting
First Posted : July 9, 2021
Last Update Posted : September 22, 2022
Sponsor:
Collaborator:
Rho, Inc.
Information provided by (Responsible Party):
ImStem Biotechnology

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: IMS001 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 31, 2021
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Low Dose
Low dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1.
 Biological: IMS001
IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC).
Experimental: High Dose
High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1.
 Biological: IMS001
IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC).
Experimental: Optional Dose
High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1 and at Month 6.
 Biological: IMS001
IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC).


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: Day 1 to Month 60 ]
    Frequency of treatment-emergent adverse events (TEAEs).

  2. Safety and tolerability [ Time Frame: Day 1 to Month 60 ]
    Clinically significant laboratory abnormalities.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04956744


Contacts
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Contact: Richard Kim, MD 860-281-7836 richard.kim@imstem.com

Locations
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United States, Georgia
Shepherd Center Recruiting
Atlanta, Georgia, United States, 30309
United States, Massachusetts
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01605
United States, Utah
Rocky Mountain MS Clinic Recruiting
Salt Lake City, Utah, United States, 84103
Sponsors and Collaborators
ImStem Biotechnology
Rho, Inc.
Investigators
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Study Director: Richard Kim, MD ImStem Biotechnology
More Information
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Additional Information:

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Responsible Party: ImStem Biotechnology
ClinicalTrials.gov Identifier: NCT04956744    
Other Study ID Numbers: IMS001-01
First Posted: July 9, 2021    Key Record Dates
Last Update Posted: September 22, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases