Idiopathic Pulmonary Fibrosis (IPF)Phase 1NCT07515066
Safety and Efficacy of Nebulized 3D-cultured Human Placental Mesenchymal Stem Cell-derived Extracellular Vesicles (hPMSC-EVs) for Idiopathic Pulmonary Fibrosis
A Phase 1 study testing 3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles in people with Idiopathic Pulmonary Fibrosis (IPF), run by Huan Ye at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- 3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 30 Apr 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Chest Hospital, Capital Medical University
Beijing
Huan Ye, MD, 010-89509000, yedahuan@yeah.net
Huan Ye, MD
About this study
Official 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
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.
Read more
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)
- Being tested
- 3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles
- Keywords
- Idiopathic Pulmonary Fibrosis, Extracellular Vesicles, Mesenchymal Stem Cells, Stem Cell Therapy
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-cultured human placental mesenchymal stem cell-derived extracellular vesiclesBiological
Also called hPMSC-EVs
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.
3D-cultured human placental mesenchymal stem cell-derived extracellular vesiclesBiological
Also called hPMSC-EVs
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.
3D-cultured human placental mesenchymal stem cell-derived extracellular vesiclesBiological
Also called hPMSC-EVs
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | Level 1: 1.0×10⁹ particles per treatment Receives: Biological: 3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles |
| Dose Level 2 | Experimental | Level 2: 2.0×10⁹ particles per treatment Receives: Biological: 3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles |
| Dose Level 3 | Experimental | 3.0×10⁹ particles per treatment Receives: Biological: 3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first dose to 4 weeks after last dose (up to Day 35)
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.
Measured: During the first 7-day treatment course and follow-up to Day 28
Secondary outcomes (5)
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.
Measured: Baseline, Day 8, Day 28, 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.
Measured: Baseline, Day 8, Day 28, 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.
Measured: Baseline, Day 8, Day 28, 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.
Measured: Baseline, Day 8, Day 28, Day 84
Change in chest high-resolution computed tomography (HRCT) findings from baseline
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.
Measured: Baseline, Day 28, Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huan Ye
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huan Ye, Beijing Chest Hospital
- Investigators
- Jingtao Gao, MD, Principal investigator, Beijing Chest Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515066
- Sponsor's protocol ID
- KY-2026-1
- Other IDs
- KY-2026-1
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07515066
- Acronym / sponsor ID
- KY-2026-1
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- Idiopathic Pulmonary Fibrosis, Extracellular Vesicles, Mesenchymal Stem Cells, Stem Cell Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Huan YeUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Biological: 3D-cultured human placental mesenchymal stem cell-derived extracellular vesiclesLevel 1: 1.0×10⁹ particles per treatment |
| Dose Level 2 | Experimental | Biological: 3D-cultured human placental mesenchymal stem cell-derived extracellular vesiclesLevel 2: 2.0×10⁹ particles per treatment |
| Dose Level 3 | Experimental | Biological: 3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles3.0×10⁹ particles per treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-cultured human placental mesenchymal stem cell-derived extracellular vesiclesAlso: hPMSC-EVs3D-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 | Dose Level 1 |
| 3D-cultured human placental mesenchymal stem cell-derived extracellular vesiclesAlso: hPMSC-EVs3D-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 | Dose Level 2 |
| 3D-cultured human placental mesenchymal stem cell-derived extracellular vesiclesAlso: hPMSC-EVs3D-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. | Biological | Dose Level 3 |
Primary outcome
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.
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.
5 secondary outcomes
Change in forced vital capacity (FVC % predicted) from baseline
Time frame: Baseline, Day 8, Day 28, Day 84
Change in diffusing capacity of the lung for carbon monoxide (DLCO % predicted) from baseline
Time frame: Baseline, Day 8, Day 28, Day 84
Change in 6-minute walking distance (6MWD) from baseline
Time frame: Baseline, Day 8, Day 28, Day 84
Change in Saint George's Respiratory Questionnaire (SGRQ) total score from baseline
Time frame: Baseline, Day 8, Day 28, Day 84
Change in chest high-resolution computed tomography (HRCT) findings from baseline
Time frame: Baseline, Day 28, Day 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jingtao Gao, MD principal investigator
Beijing Chest Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles in people with Idiopathic Pulmonary Fibrosis (IPF), run by Huan Ye at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huan Ye, MD (010-89509000, ye.huan@bjchest.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.