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

NCT04723303 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-01-24

No results posted yet for this study

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.

Conditions

  • Polymyositis
  • Dermatomyositis

Interventions

DRUG

Umbilical Cord Lining Stem Cells

An IV infusion of ULSCs will be administered.

Sponsors & Collaborators

  • Restem, LLC.

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Carl Pepine, MD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2023-12-12
Completion
2024-03-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04723303 on ClinicalTrials.gov