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Allogeneic Mitochondria (PN-101) Transplantation for Refractory Polymyositis or Dermatomyositis

NCT04976140 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-04-03

No results posted yet for this study

Summary

To determine the maximum tolerated dose (MTD) based on the safety and tolerability after single-dose administration of PN-101 in patients with refractory polymyositis or dermatomyositis. To explore the efficacy after single-dose administration of PN-101 in patients with refractory polymyositis or dermatomyositis.

Conditions

  • Polymyositis
  • Dermatomyositis

Interventions

BIOLOGICAL

PN-101

PN-101: Mitochondria isolated from Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells. 3 or 6 subjects are enrolled in each dose group in line with the traditional 3+3 rule-based method, and the investigator intravenously administers a single-dose of the investigational product according to the planned dose.

Sponsors & Collaborators

  • Paean Biotechnology Inc.

    lead INDUSTRY

Principal Investigators

  • Eunyoung Lee, MD · Seoul National University College of Medicine

  • Daehyun Yoo, MD · Hanyang University College of Medicine

  • Hyunsook Kim, MD · Soonchunhyang University College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2023-10-06
Completion
2023-10-06

Countries

  • South Korea

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 NCT04976140 on ClinicalTrials.gov