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

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IMS001
Sponsored by
ImStem Biotechnology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shepherd CenterRecruiting
  • UMass Memorial Medical CenterRecruiting
  • Rocky Mountain MS ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low Dose

High Dose

Optional Dose

Arm Description

Low dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1.

High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1.

High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1 and at Month 6.

Outcomes

Primary Outcome Measures

Safety and tolerability
Frequency of treatment-emergent adverse events (TEAEs).
Safety and tolerability
Clinically significant laboratory abnormalities.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2021
Last Updated
September 26, 2023
Sponsor
ImStem Biotechnology
Collaborators
Rho, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04956744
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImStem Biotechnology
Collaborators
Rho, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Dose
Arm Type
Experimental
Arm Description
Low dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1.
Arm Title
High Dose
Arm Type
Experimental
Arm Description
High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1.
Arm Title
Optional Dose
Arm Type
Experimental
Arm Description
High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1 and at Month 6.
Intervention Type
Biological
Intervention Name(s)
IMS001
Intervention Description
IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC).
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
Frequency of treatment-emergent adverse events (TEAEs).
Time Frame
Day 1 to Month 60
Title
Safety and tolerability
Description
Clinically significant laboratory abnormalities.
Time Frame
Day 1 to Month 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Kim, MD
Phone
860-281-7836
Email
richard.kim@imstem.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Kim, MD
Organizational Affiliation
ImStem Biotechnology
Official's Role
Study Director
Facility Information:
Facility Name
Shepherd Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Individual Site Status
Recruiting
Facility Name
Rocky Mountain MS Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Links:
URL
http://www.imstem.com/
Description
Imstem Biotechnology

Learn more about this trial

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

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