RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2021-08-31

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04956744

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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

Study Contact

Richard Kim, MD

CONTACT

860-281-7836

richard.kim@imstem.com

Principal Investigator

Richard Kim, MD

STUDY_DIRECTOR

ImStem Biotechnology

Study Locations (Sites)

Shepherd Center

Atlanta, Georgia, 30309

United States

UMass Memorial Medical Center

Worcester, Massachusetts, 01605

United States

Rocky Mountain MS Clinic

Salt Lake City, Utah, 84103

United States

Collaborators and Investigators

Sponsor: ImStem Biotechnology

Richard Kim, MD, STUDY_DIRECTOR, ImStem Biotechnology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-31

Study Completion Date2027-12

Study Record Updates

Study Start Date2021-08-31

Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

Multiple Sclerosis