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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to month 60
Awards & highlights

Study Summary

This trial is testing whether a single dose of IMS001, a human embryonic cell-derived mesenchymal stem cell, is safe and tolerable for people with Multiple Sclerosis who haven't responded well to other treatments.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability

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.

Find a Location

Who is running the clinical trial?

ImStem BiotechnologyLead Sponsor
Rho, Inc.Industry Sponsor
24 Previous Clinical Trials
5,733 Total Patients Enrolled
Richard Kim, MDStudy DirectorImStem Biotechnology
2 Previous Clinical Trials
603 Total Patients Enrolled

Media Library

Multiple Sclerosis Research Study Groups: Low Dose, High Dose, Optional Dose
Multiple Sclerosis Clinical Trial 2023: IMS001 Highlights & Side Effects. Trial Name: NCT04956744 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current opportunities to join this trial?

"Affirmative. Clinicaltrials.gov reveals that this experiment, initially posted on August 31st 2021 is currently enrolling individuals. 30 participants are needed from 3 separate sites for the trial's completion."

Answered by AI

Does this clinical trial permit the participation of individuals over 25 years old?

"This research project is open to people aged 18-65."

Answered by AI

Are there any restrictions on who can participate in this experiment?

"This MS clinical trial is only accessible to participants aged 18 to 65, and a maximum of 30 people will be accepted."

Answered by AI

Has IMS001 received clearance from the U.S. Food and Drug Administration?

"The safety profile of IMS001 has been rated as a 1 due to this being an initial Phase 1 trial, so there is only minimal evidence for its efficacy and no clinical data supporting its security."

Answered by AI

To what capacity is this research project accepting participants?

"Affirmative. According to the clinicaltrials.gov database, this trial is presently in search of participants and was initially posted on August 31st 2021 with a most recent update on September 20th 2022. The study requires 30 patients enrolled between 3 medical centres."

Answered by AI

Who else is applying?

What state do they live in?
Mississippi
Georgia
How old are they?
18 - 65
What site did they apply to?
Shepherd Center
UMass Memorial Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis
2021. "A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04956744.
All > Multiple Sclerosis
~17 spots leftby Dec 2027
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