MedTrace Logo

Safety and Efficacy of Nebulized 3D-cultured Human Placental Mesenchymal Stem Cell-derived Extracellular Vesicles (hPMSC-EVs) for Idiopathic Pulmonary Fibrosis

NCT07515066 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-04-07

No results posted yet for this study

Summary

This is a single-center, open-label, dose-escalation clinical study to evaluate the safety and efficacy of nebulized 3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles (hPMSC-EVs) in patients with idiopathic pulmonary fibrosis (IPF).

Eligible participants will be assigned to one of three dose groups (1.0×10⁹, 2.0×10⁹, or 3.0×10⁹ particles per treatment) using a 3+3 design. All participants will receive nebulized hPMSC-EVs twice daily for 7 consecutive days.

The main purpose of this study is to assess the safety and tolerability of hPMSC-EVs, including the incidence of adverse events, changes in vital signs, laboratory tests, and immune markers. Secondary objectives include evaluating changes in lung function (FVC, DLCO), 6-minute walking distance, respiratory symptoms (SGRQ score), and chest HRCT findings.

Participants will undergo screening visits, treatment administration, and follow-up visits up to 12 months after the first dose to monitor safety and efficacy outcomes.

Conditions

  • Idiopathic Pulmonary Fibrosis (IPF)

Interventions

BIOLOGICAL

3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles

3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles (hPMSC-EVs) are administered via nebulization inhalation. The intervention is diluted in 6 mL of normal saline to a total volume of 7.5 mL, and delivered using a vibrating mesh nebulizer to target the lower respiratory tract. Three dose levels are evaluated: 1.0×10⁹ particles per treatment, administered twice daily (9:00±30 min and 20:00±30 min) for 7 consecutive days per treatment course.

BIOLOGICAL

3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles

3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles (hPMSC-EVs) are administered via nebulization inhalation. The intervention is diluted in 6 mL of normal saline to a total volume of 7.5 mL, and delivered using a vibrating mesh nebulizer to target the lower respiratory tract. Three dose levels are evaluated: 2.0×10⁹particles per treatment, administered twice daily (9:00±30 min and 20:00±30 min) for 7 consecutive days per treatment course.

BIOLOGICAL

3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles

3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles (hPMSC-EVs) are administered via nebulization inhalation. The intervention is diluted in 6 mL of normal saline to a total volume of 7.5 mL, and delivered using a vibrating mesh nebulizer to target the lower respiratory tract. Three dose levels are evaluated: 3.0×10⁹ particles per treatment, administered twice daily (9:00±30 min and 20:00±30 min) for 7 consecutive days per treatment course.

Sponsors & Collaborators

  • Huan Ye

    lead OTHER

Principal Investigators

  • Jingtao Gao, MD · Beijing Chest Hospital, Capital Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-04-30
Completion
2029-04-30

Countries

  • China

Study Locations

More Related Trials

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 NCT07515066 on ClinicalTrials.gov