Evaluating IMS001 for Multiple Sclerosis Treatment

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)

This study is testing a new stem cell treatment called IMS001 to see if it can help people with Multiple Sclerosis who haven't had success with other medications.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: ImStem Biotechnology (Industry-sponsored)
• Locations: 3 sites (Atlanta, Georgia and 2 other locations)
• Trial ID: NCT04956744 on ClinicalTrials.gov

What this trial studies

This Phase 1 study evaluates the safety, tolerability, and exploratory efficacy of IMS001, a human embryonic cell-derived mesenchymal stem cell therapy, in patients with Multiple Sclerosis who have not responded adequately to existing disease-modifying treatments. Participants will receive a single dose of IMS001 and will be monitored for their response and any adverse effects. The study aims to assess the potential of MSCs to modulate the disease course in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of Multiple Sclerosis and an inadequate response to disease-modifying treatments.

Not a fit: Patients with a history of certain autoimmune diseases, neoplastic diseases, or prior allogeneic cell therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with Multiple Sclerosis who have not responded to current therapies.

How similar studies have performed: While the use of MSCs in treating Multiple Sclerosis is an emerging field, this specific approach with IMS001 is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Atlanta, Georgia and 2 other locations

• Shepherd Center — Atlanta, Georgia, United States (Recruiting)
• UMass Memorial Medical Center — Worcester, Massachusetts, United States (Recruiting)
• Rocky Mountain MS Clinic — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Study coordinator: Richard Kim, MD

Conditions Multiple Sclerosis