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(352) 733-0111

PMDM

  • Status
    Accepting Candidates
  • Age
    18 Years - 90 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Details

Full study title Phase 1 Study of Mesenchymal Stromal Cells, Umbilical Cord Lining Stem Cells (ULSC), in Patients with Polymyositis (PM) and Dermatomyositis (DM)
Protocol number OCR33722
ClinicalTrials.gov ID NCT04723303
Phase Early Phase 1

Eligibility

Inclusion Criteria:

  1. Adult, male or female, age ≥18 years old

  2. Diagnosis of definite or probable DM or PM, according to the criteria of Bohan and Peter

  3. 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).

  4. Signs informed consent.

Exclusion Criteria:

  1. A diagnosis of inclusion body myositis, juvenile DM or PM, myositis in the context of significant overlap with another systemic autoimmune rheumatologic disease.

  2. Non immune myopathies.

  3. Cancer associated myositis.

  4. Hypersensitivity to study product components. History of hypersensitivity to dimethyl sulfoxide (DMSO).

  5. Pregnant or lactating women.

  6. Concomitant severe cardiac, pulmonary disease, active infection or other conditions that preclude assessment of safety and efficacy of the study product.

  7. 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.

  8. Anticipated need for surgery during the trial period.

  9. A history of prevalent noncompliance with medical therapy.

  10. Recipient of an organ transplant.

  11. Neutropenia (absolute neutrophil count

Lead researcher

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

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