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NCT Number: NCT07515066

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

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Chest Hospital, Capital Medical University

Beijing, China

Location contact

Huan Ye, MD

CONTACT

[email protected]

010-89509000

Huan Ye, MD

PRINCIPAL_INVESTIGATOR

Jingtao Gao, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 6-minute walking distance (6MWD) >150 meters at screening.
  • Willing to use effective contraception during the study and for 12 months after the last dose of study treatment (for subjects of childbearing potential, including male subjects whose spouses are of childbearing potential).
  • Signed and dated written informed consent form prior to any study-related procedures.
  • Able to comply with all study procedures and scheduled follow-up visits.

Exclusion criteria

  • 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.
  • Pregnant, breastfeeding, or planning pregnancy within 12 months after the last dose of study treatment.
  • Malignancy within 5 years prior to screening (except adequately treated basal cell carcinoma or cervical carcinoma in situ).
  • Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
  • History of solid organ or hematopoietic stem cell transplantation, or being on the transplant waiting list.
  • Requirement for long-term oxygen therapy for more than 15 hours per day.
  • Severe cardiac, hepatic, renal, or other systemic diseases that, in the investigator's judgment, would compromise study participation or confound study results.
  • Participation in another interventional clinical trial within 3 months prior to screening.

Treatment and study plan

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

Biological

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.

Other names: hPMSC-EVs

Primary outcomes

  1. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: From first dose to 4 weeks after last dose (up to Day 35)

    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.

  2. Maximum tolerated dose (MTD) of nebulized hPMSC-EVs

    Time frame: During the first 7-day treatment course and follow-up to Day 28

    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.

Secondary outcomes

  1. Change in forced vital capacity (FVC % predicted) from baseline

    Time frame: Baseline, Day 8, Day 28, Day 84

    Absolute and percent change in predicted forced vital capacity (FVC) from baseline to Day 8, Day 28, and Day 84.

  2. Change in diffusing capacity of the lung for carbon monoxide (DLCO % predicted) from baseline

    Time frame: Baseline, Day 8, Day 28, Day 84

    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.

  3. Change in 6-minute walking distance (6MWD) from baseline

    Time frame: Baseline, Day 8, Day 28, Day 84

    Absolute and percent change in 6-minute walking distance (6MWD) from baseline to Day 8, Day 28, and Day 84.

  4. Change in Saint George's Respiratory Questionnaire (SGRQ) total score from baseline

    Time frame: Baseline, Day 8, Day 28, Day 84

    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.

  5. Change in chest high-resolution computed tomography (HRCT) findings from baseline

    Time frame: Baseline, Day 28, Day 84

    Change in interstitial lung disease extent and fibrosis score on chest high-resolution computed tomography (HRCT) from baseline to Day 28 and Day 84, evaluated by two independent radiologists.

Study contacts

Contact information is provided by the study sponsor or research team.

Huan Ye, MD

CONTACT

[email protected]

010-89509000

Sponsors and collaborators

Lead sponsor

Huan Ye

Other

Registry information

Official study title

A Single-center, Open-label, Single and Multiple Dose, Dose-escalation Exploratory 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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