What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include interferon beta-1a, fingolimod, dimethyl fumarate, and glatiramer acetate. Interferon beta-1a can cause flu-like symptoms, injection site reactions, and elevated liver enzymes. Fingolimod is associated with headache, elevated liver enzymes, bradyarrhythmia, macular edema, and increased risk of infections. Dimethyl fumarate may cause flushing, gastrointestinal issues, and lymphopenia. Glatiramer acetate's side effects include injection site reactions and, rarely, systemic reactions. Mesenchymal stem cell (MSC) treatments, like IMS001, are still under investigation, but potential side effects may include immune reactions and infection risks.

What prior FDA approvals exist?

The FDA has approved several disease-modifying therapies for the treatment of Multiple Sclerosis, including interferon beta-1a (Avonex, Rebif), interferon beta-1b (Betaseron), and glatiramer acetate (Copaxone). These treatments primarily aim to reduce relapse rates and slow disease progression. More recently, oral medications like dimethyl fumarate (Tecfidera) have also been approved. While mesenchymal stem cells (MSCs) like those studied in IMS001 are still under investigation, they hold promise for modulating the disease course in MS patients who do not respond adequately to existing treatments.

What other types of research exist?

Promising novel alternatives to IMS001 for Multiple Sclerosis patients include: 1) Ponesimod, an oral S1PR modulator approved for relapsing forms of MS, which has shown efficacy in reducing relapse rates and MRI lesions. 2) Hematopoietic Stem Cell Transplantation (HSCT), which has demonstrated lower relapse rates and improved neurologic function in patients with refractory MS. 3) Siponimod, a selective S1P receptor modulator, which has shown efficacy in slowing disability progression in secondary progressive MS (SPMS).

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Mesenchymal Stem Cell Therapy

IMS001 for Multiple Sclerosis

Phase 1

Recruiting

Research Sponsored by ImStem Biotechnology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of MS

Aged between 18 to 65 years

Must not have

Body weight equal to or greater than 120 kg

Prior history of any other autoimmune disease, myelodysplasia, or hematologic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to month 60

Awards & highlights

No Placebo-Only Group

Summary

This trial tests IMS001, a treatment made from special cells, on Multiple Sclerosis patients who haven't had success with other treatments. These cells might help control or slow down the disease.

Who is the study for?

This trial is for adults aged 18-65 with Multiple Sclerosis who haven't had success with standard treatments. Participants must be able to have MRIs, not have other autoimmune or blood diseases, no recent serious infections, and should not be pregnant. They also need to be free from certain medications and conditions that could affect the study.

What is being tested?

IMS001, a therapy derived from human embryonic stem cells designed to potentially alter the course of Multiple Sclerosis, is being tested. This Phase 1 trial involves giving a single dose to participants who didn’t respond well to existing disease-modifying treatments.

What are the potential side effects?

Specific side effects are not listed but may include reactions related to stem cell therapies such as immune responses or infusion-related reactions. Close monitoring will occur due to the potential for unknown risks associated with new treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with multiple sclerosis (MS).

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I am between 18 and 65 years old.

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I have been in stable health for the last month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My body weight is 120 kg or more.

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I have a history of autoimmune, myelodysplasia, or blood diseases.

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I have had a serious infection recently.

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I have smoked the equivalent of 20 or more pack-years.

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I have had a transplant from a donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to month 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to month 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to month 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and tolerability

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Optional DoseExperimental Treatment1 Intervention

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

Group II: Low DoseExperimental Treatment1 Intervention

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

Group III: High DoseExperimental Treatment1 Intervention

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Sclerosis (MS) include disease-modifying therapies (DMTs) such as beta interferons, glatiramer acetate, and newer agents like dimethyl fumarate and teriflunomide. These treatments primarily work by modulating the immune system to reduce inflammation and prevent immune cells from attacking the myelin sheath. Mesenchymal stem cells (MSCs), like those in the IMS001 trial, offer a novel approach by potentially modulating the disease course through their immunomodulatory and neuroprotective properties. This is significant for MS patients as it provides a potential treatment option that not only targets inflammation but also promotes repair and regeneration of damaged tissues, potentially improving long-term outcomes.

Adoptive transfer of cytokine-induced immunomodulatory adult microglia attenuates experimental autoimmune encephalomyelitis in DBA/1 mice.