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

Sponsor
ImStem Biotechnology (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04956744
Collaborator
Rho, Inc. (Industry)
30
Enrollment
3
Locations
3
Arms
75
Anticipated Duration (Months)
10
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: IMS001
 Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Aug 31, 2021
Anticipated Primary Completion Date :
Dec 1, 2027
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

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

Primary Outcome Measures

  1. Safety and tolerability [Day 1 to Month 60]

    Frequency of treatment-emergent adverse events (TEAEs).

  2. Safety and tolerability [Day 1 to Month 60]

    Clinically significant laboratory abnormalities.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shepherd Center Atlanta Georgia United States 30309
2 UMass Memorial Medical Center Worcester Massachusetts United States 01605
3 Rocky Mountain MS Clinic Salt Lake City Utah United States 84103

Sponsors and Collaborators

  • ImStem Biotechnology
  • Rho, Inc.

Investigators

  • Study Director: Richard Kim, MD, ImStem Biotechnology

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
ImStem Biotechnology
ClinicalTrials.gov Identifier:
NCT04956744
Other Study ID Numbers:
  • IMS001-01
First Posted:
Jul 9, 2021
Last Update Posted:
Sep 21, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis

Study Results

No Results Posted as of Sep 21, 2021