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.
Age 18 to 75 years, male or female at the time of signing the informed consent form.
Confirmed diagnosis of idiopathic pulmonary fibrosis (IPF) in accordance with the 2022 ATS/ERS/JRS/ALAT clinical criteria.
Forced vital capacity (FVC) ≥50% and ≤80% of predicted value, and hemoglobin-corrected diffusing capacity of the lung for carbon monoxide (DLCO) ≥30% and ≤80% of predicted value at screening.
Stable dose of antifibrotic therapy (nintedanib, pirfenidone, or nerandomilast) for at least 8 weeks prior to screening.
Prior treatment with stem cell-derived products or extracellular vesicles for any disease.
Inability to tolerate nebulized inhalation therapy.
History of severe drug allergy or anaphylaxis to any component of the study treatment or nebulization materials.
Diagnosis of bronchial asthma or other active respiratory diseases that may interfere with study assessments.
Parallel
3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles
Biological/Vaccine3D-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.
3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles
Biological/Vaccine3D-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.
3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles
Biological/Vaccine3D-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.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Incidence and severity of all adverse events (AEs) and serious adverse events (SAEs) from first dose administration to 4 weeks after the last dose, graded according to NCI-DAIDS criteria.
Maximum tolerated dose (MTD) of nebulized hPMSC-EVs
Maximum tolerated dose (MTD) defined as the highest dose level with ≤1 dose-limiting toxicity (DLT) observed in 3 participants during the first treatment course.
Change in forced vital capacity (FVC % predicted) from baseline
Absolute and percent change in predicted forced vital capacity (FVC) from baseline to Day 8, Day 28, and Day 84.
Change in diffusing capacity of the lung for carbon monoxide (DLCO % predicted) from baseline
Absolute and percent change in hemoglobin-corrected predicted diffusing capacity of the lung for carbon monoxide (DLCO) from baseline to Day 8, Day 28, and Day 84.
Change in 6-minute walking distance (6MWD) from baseline
Absolute and percent change in 6-minute walking distance (6MWD) from baseline to Day 8, Day 28, and Day 84.
Change in Saint George's Respiratory Questionnaire (SGRQ) total score from baseline
Change in Saint George's Respiratory Questionnaire (SGRQ) total score and domain scores (Symptoms, Activity, Impact) from baseline to Day 8, Day 28, and Day 84. A lower score indicates better respiratory-related quality of life.
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Huan Ye
Lead sponsor
Beijing Chest Hospital
Sponsor institution
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