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Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04956744
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	ImStem Biotechnology
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Richard Kim, MD
Principal Investigator Affiliation	ImStem Biotechnology
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Low Dose

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

Experimental: High Dose

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

Experimental: Optional Dose

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

Interventions

Biological: - IMS001

IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Shepherd Center, Atlanta, Georgia

Status

Recruiting

Address

Shepherd Center

Atlanta, Georgia, 30309

Site Contact

[email protected]

860-281-7836

UMass Memorial Medical Center, Worcester, Massachusetts

Status

Recruiting