CompletedEarly Phase 1

Phase 1 Study of ULSC in Patients With Polymyositis (PM) and Dermatomyositis (DM)

United States10 participantsStarted 2021-10-06

Plain-language summary

This study will investigate Umbilical Cord Lining Stem Cells (ULSC) as an investigational medicinal product and its use in patients with polymyositis (PM) or dermatomyositis (DM) to see if a single intravenous (IV) infusion of allogeneic umbilical cord lining stem cells (ULSC) safe, tolerable, and feasible to administer.

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion criteria

✓. Adult, male or female, age ≥18 years old
✓. Diagnosis of definite or probable DM or PM, according to the criteria of Bohan and Peter
✓. Patients with PM will either be positive for a myositis-associated antibody or have undergone evaluation to exclude mimics, as deemed appropriate by the Investigator (See Note below).
✓. Signs informed consent.

Exclusion criteria

✕. A diagnosis of inclusion body myositis, juvenile DM or PM, myositis in the context of significant overlap with another systemic autoimmune rheumatologic disease.
✕. Non immune myopathies.
✕. Cancer associated myositis.
✕. Hypersensitivity to study product components. History of hypersensitivity to dimethyl sulfoxide (DMSO).
✕. Pregnant or lactating women.
✕. Concomitant severe cardiac, pulmonary disease, active infection or other conditions that preclude assessment of safety and efficacy of the study product.
✕. Patients with predominant muscle atrophy secondary to uncontrolled or chronic DM or PM, based on clinical, biochemical, and/or radiologic assessment, despite previous optimized treatment.
✕. Anticipated need for surgery during the trial period.

What they're measuring

Number of Subjects with Dose Limiting Toxicity (DLT) that begins during or following ULSC infusion as assessed within 24 hours.

Timeframe: Within 24 hours

Trial details

NCT IDNCT04723303

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-12

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