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ULSC for Dermatomyositis/Polymyositis (IIM)

This study is looking at an investigational treatment called ULSC (umbilical-cord lining stem cells) for adults with Dermatomyositis or Polymyositis (DM/PM), also known as Idiopathic Inflammatory Myopathy (IIM). Researchers want to see if ULSC is safe and helps improve symptoms of DM/PM. You would receive ULSC or a placebo (a saline solution without cells) through an IV three times. The study will compare how people feel after receiving ULSC versus the placebo. To join, you must be at least 18 years old and have an active diagnosis of IIM, which includes certain blood test results like elevated Creatine Kinase (CK) or Aldolase.

Study design
This interventional study plans to enroll 40 participants. It compares ULSC to a placebo (a look-alike saline without cells).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored at each visit from Day 0, 7 days, and 30 days after each infusion, and all follow-up visits up to 12 months after the final treatment infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07160205

Safety and Efficacy of ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM), Also Known as Idiopathic Inflammatory Myopathy (IIM)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Restem, LLC.
~40 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:ULSC (1.5 x 10^8 cells/dose)Placebo (no cells)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety based on Adverse Events (AEs) and Serious Adverse Events (SAEs) that begin during or following treatment infusion.
Measured over Each visit from Day 0, 7 days, and 30 days after each infusion, and all follow-up visits up to 12 months after the final treatment infusion.
+1 more outcome measured

Conditions

Idiopathic Inflammatory Myositis (IIM)
DERMATOMYOSITIS OR POLYMYOSITIS

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Where it's being run

2 sites across 1 states
Florida2

Study leadership

  • Michael Bubb, MD · PRINCIPAL_INVESTIGATOR · Malcom Randall North Florida/South Georgia VA Medical Center

Who to contact

Clinical Trial Contact
[email protected]
352-278-8838
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Medical history and physical exam to determine the clinical course and progression of symptoms, the distribution of weakness, and the absence of features of myelopathy, neuropathy, neuromuscular disease, myotonic dystrophy, and congenital myopathy;
Elevated Creatine Kinase (CK) or Aldolase levels in blood;
Electromyography (EMG) and/or MRI of clinically affected 99+proximal muscle group;
Myositis-specific and myositis-associated autoantibodies in blood;
Muscle biopsy with characteristic features of IIM and excluding features of muscular dystrophy, metabolic myopathies, drug-induce myopathy, inclusion body myopathy, and necrotizing myopathy;

What this trial measures

  • Safety based on Adverse Events (AEs) and Serious Adverse Events (SAEs) that begin during or following treatment infusion.Each visit from Day 0, 7 days, and 30 days after each infusion, and all follow-up visits up to 12 months after the final treatment infusion.

    Cumulative listing of all AEs/SAEs per cohort with descriptive statistics for categorical variables and count variables to compare between ULSC and Placebo, with emphasis on All SAEs and AEs/SAEs suspected to be treatment infusion-related.

  • Efficacy based on Total Improvement Score (TIS, expressed as continuous variable) in the 2016 ACR/EULAR Myositis Response CriteriaFrom baseline (i.e., before first dose per treatment) to 7 months (i.e., one month after the third/final dose per treatment) for each treatment group and each study period.

    Total Improvement Score (TIS) as continuous variable (scale of 0 to 100 points) will be assessed; TIS is a weighted average of the sub-scores in the 6 core set measures that comprise the validated outcome measure in the 2016 ACR/EULAR Myositis Response Criteria.