Recruiting

IIMPACTUmbilical Cord Stem Cells for Dermatomyositis/Polymyositis

What is being tested

ULSC (1.5 x 10^8 cells/dose)

+ Placebo (no cells)

Biological

Who is being recruted

Connective Tissue Diseases+7

+ Dermatomyositis

+ Muscular Diseases

Over 18 Years

+34 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2 & 3

Interventional

Study Start: January 2026

See protocol details

Summary

Principal SponsorRestem, LLC.

Last updated: February 4, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 6, 2026

Actual date on which the first participant was enrolled.

This clinical trial aims to explore the effectiveness and safety of a new treatment for adults diagnosed with Dermatomyositis or Polymyositis, which are types of inflammatory muscle diseases. The treatment involves using stem cells derived from the lining of the umbilical cord, known as ULSC, to help alleviate the symptoms of these conditions. The study hopes to determine whether this treatment can safely reduce disease severity and allow patients to decrease their reliance on steroids, which are often used to manage these conditions. By addressing these aspects, the study could potentially offer a new therapeutic option for individuals with these challenging diseases. Participants in the study will receive intravenous infusions of the stem cell product and a placebo, each given in a specific order, over a period of 25 months. They will participate in 15 in-person clinic visits and 8 virtual appointments. Each person will receive three doses of ULSC and three doses of placebo in alternating sequences. During the study, the effects on symptoms will be assessed through various methods, including physical exams, muscle strength tests, and blood tests, among others. Participants may also see a reduction in their steroid medication doses if they are already undergoing such therapy. This comprehensive approach is designed to thoroughly evaluate the potential benefits and risks of the ULSC treatment for these conditions.

Official TitleA Phase 2-Phase 3, Double-blinded, Randomized, Dose-repeating, Cross-over Study to Assess the Safety and Efficacy of Allogeneic ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM)

NCT07160205

Principal SponsorRestem, LLC.

Last updated: February 4, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Connective Tissue DiseasesDermatomyositisMuscular DiseasesMusculoskeletal DiseasesMyositisNervous System DiseasesNeuromuscular DiseasesSkin DiseasesPolymyositisSkin and Connective Tissue Diseases

Criteria

11 inclusion criteria required to participate

Diagnosis of idiopathic inflammatory myositis (IIM) based on 2017 EULAR/ACR Classification Criteria for adult IIM, corresponding to a score of ≥ 5.5 (≥ 6.7 with muscle biopsy).

Participants will be ≥18 years old.

Active disease as defined by any one of the following test results: Elevated Creatine Kinase (CK) or Aldolase (more than 1.5 x the upper limit of normal) at screening, OR MRI positive for active, muscle inflammation within 12 weeks prior to screening, OR EMG read as active myositis within 12 weeks prior to screening, OR muscle biopsy obtained within 12 weeks of the screening showing active inflammatory disease.

Muscle weakness or active cutaneous manifestations of dermatomyositis assessed at Screening and documented with either of the following scores: Bilateral MMT-8 score of ≤142/150, OR CDASI Total Activity score of ≥ 7.

Show More Criteria

23 exclusion criteria prevent from participating

Diagnosis of IIM as part of an overlap syndrome (except overlap with Sjogren's syndrome).

Pregnant or lactating participants.

A diagnosis of inclusion body myositis, juvenile DM or PM, myositis in the context of significant autoimmune rheumatologic disease.

Initiation of Rituxan (rituximab) treatment within 12 weeks of randomization. If participant is already on Rituxan, they must remain on a stable dose throughout the trial.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Cohort 1 will receive 1.5 x 10\^8 ULSC per dose through IV infusion on Day 0, Month 3, and Month 6 (total of three doses). One month after the third dose, Cohort 1 will cross-over to receive Placebo IV infusion on Month 7, Month 10, and Month 13.

Group II

Experimental

Cohort 2 will receive Placebo IV infusion on Day 0, Month 3, and Month 6 (total of three Placebo infusions). One month after the third dose, Cohort 2 will cross-over to receive 1.5 x 10\^8 ULSC per dose through IV infusion on Month 7, Month 10, and Month 13.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Malcom Randall North Florida/South Georgia VA Medical Center

Gainesville, United StatesOpen Malcom Randall North Florida/South Georgia VA Medical Center in Google Maps

Recruiting

Bioresearch Partner

Miami, United States

Recruiting

2 Study Centers