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

  • End date
    Apr 20, 2022
  • participants needed
  • sponsor
    University of Florida
Updated on 27 November 2021


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.

Condition Idiopathic Inflammatory Myopathies, Skin Conditions, Dermatomyositis, Polymyositis, Connective Tissue Diseases, Myositis, Congenital Skin Diseases, Polymyositis (Inflammatory Muscle Disease), Dermatosis, Dermatomyositis (Connective Tissue Disease), CONNECTIVE TISSUE DISEASE
Treatment MESENCHYMAL STROMAL CELLS (MSC's), Umbilical Cord Lining Stem Cells
Clinical Study IdentifierNCT04723303
SponsorUniversity of Florida
Last Modified on27 November 2021


Yes No Not Sure

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
A history of prevalent noncompliance with medical therapy
Recipient of an organ transplant
Neutropenia (absolute neutrophil count<1,800/mm3 [or <1,000/mm3 in African-American subjects])
Severe impairment in renal function (estimated glomerular filtration rate <30 ml/kgmin)
Recent or planned use of vaccination with live attenuated viruses
Active cancer or prior diagnosis of cancer within the past 2 years (patients with basal and squamous cell cancer of skin will not be excluded)
Condition that would impair an assessment of muscle strength, including neurological disorders such as Parkinson's disease or severe musculoskeletal condition
Any other condition that, in the judgment of the Investigator or Sponsor, would be a contraindication to enrollment, study product administration, or follow-up
History of Atrial septal defect or ventricular septal defect
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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