Safety and Preliminary Efficacy of hUCMSC-EVs in Interstitial Lung Disease
1. maj 2026 opdateret af: Shanghai Zhongshan Hospital
A Clinical Study to Explore the Safety and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles in the Treatment of Interstitial Lung Disease
This is an exploratory, randomized, single-blind, placebo-controlled, multiple-dose, dose-escalation clinical study. The study aims to evaluate the safety and preliminary efficacy of nebulized inhalation of Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs) in patients with interstitial lung disease (ILD).
This study is designed to include three sequential dose cohorts-low, medium, and high-with dose escalation proceeding in an ascending order. Eligible subjects will be enrolled and randomized sequentially, with a planned enrollment of 8 subjects per cohort. Within each cohort, subjects will be randomly assigned in a 3:1 ratio to receive either hUCMSC-EVs or saline placebo.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
24
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Tong, M.D
- Telefonnummer: 86-13764089607
- E-mail: tong.lin@zs-hospital.sh.cn
Studiesteder
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Shanghai, Kina
- Zhongshan Hospital, Fudan University
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Kontakt:
- Tong, M.D
- Telefonnummer: 86-13764089607
- E-mail: tong.lin@zs-hospital.sh.cn
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Ledende efterforsker:
- Yuanlin Song, M.D
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Key Inclusion Criteria:
- Age 18 years and older, regardless of gender.
- Diagnosed with interstitial lung disease (ILD).
- High-resolution computed tomography (HRCT) findings within 3 months prior to randomization must be consistent with interstitial pulmonary imaging changes.
- Pulmonary function test within the protocol-defined acceptable range prior to randomization.
- Good compliance, able to understand and cooperate with the required examinations and procedures, and willing to attend follow-up visits as scheduled.
- Voluntary participation and signing of written informed consent form.
Key Exclusion Criteria:
- Inability to tolerate nebulized inhalation therapy.
- Requirement for oxygen supplementation > 15 hours per day during the screening period.
- Allergic diathesis or a history of life-threatening drug hypersensitivity.
- History of malignancy within 5 years.
- Active hepatitis B, hepatitis C, or HIV infection.
- Active systemic infection requiring antibiotic therapy.
- Clinically significant laboratory abnormalities at screening.
- Concomitant significant or severe respiratory disease.
- History of psychiatric illness, epilepsy, or other central nervous system disorders.
- Concomitant severe cardiovascular, hepatic, or renal systemic disease.
- Pregnancy, planned pregnancy in the near future, or breastfeeding.
- Unwillingness to use effective contraception during the study period.
- Any condition that, in the opinion of the investigator, may increase the risk to the participant or interfere with the study outcomes.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Lavdosis gruppe
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hUCMSC-EVs , nebulized BID × 7d/cycle, 3 cycles
Nebulized inhalation BID × 7d per cycle, 3 cycles
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Eksperimentel: Højdosis gruppe
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hUCMSC-EVs , nebulized BID × 7d/cycle, 3 cycles
Nebulized inhalation BID × 7d per cycle, 3 cycles
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Eksperimentel: Moderate-dose group
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hUCMSC-EVs , nebulized BID × 7d/cycle, 3 cycles
Nebulized inhalation BID × 7d per cycle, 3 cycles
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Incidence and Severity of Adverse Events
Tidsramme: From first dose to Week 12
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From first dose to Week 12
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline in Forced Vital Capacity (FVC)
Tidsramme: From first dose to Week 24
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Forced Vital Capacity (FVC) will be assessed using standardized spirometry in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines.
Measurements will be performed at Baseline (prior to first dose) and at scheduled post-baseline visits.
Spirometry will be conducted using a calibrated spirometer.
Results will be summarized as absolute change from baseline and percent predicted normal values.
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From first dose to Week 24
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Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Tidsramme: From first dose to Week 24
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Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) will be assessed using the single-breath method in accordance with ATS/ERS guidelines.
Hemoglobin-corrected DLCO values will be recorded if applicable.
Measurements will be performed at Baseline and at scheduled post-baseline visits.
Results will be summarized as absolute change from baseline and percent predicted normal values.
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From first dose to Week 24
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Change from Baseline in 6-Minute Walk Test (6MWT) Distance
Tidsramme: From first dose to Week 24
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From first dose to Week 24
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Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score
Tidsramme: From first dose to Week 24
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The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure health-related quality of life in patients with chronic respiratory diseases.
The Total Score is calculated as a weighted sum of the domain scores and ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
A change of 4 units is generally considered the minimal clinically important difference (MCID).
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From first dose to Week 24
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
30. april 2026
Primær færdiggørelse (Anslået)
30. april 2027
Studieafslutning (Anslået)
30. september 2028
Datoer for studieregistrering
Først indsendt
17. april 2026
Først indsendt, der opfyldte QC-kriterier
1. maj 2026
Først opslået (Faktiske)
6. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ACE001-RI001
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Kliniske forsøg med Interstitiel lungesygdom (ILD)
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Hospital de GranollersRekrutteringInterstitiel lungesygdom (ILD) | Idiopatisk lungefibrose (IPF) | Fibrotisk interstitiel lungesygdom | Interstitiel Lungesygdom på Grund af Bindevevssygdom (Lidelse) | Suspected Interstitial Lung DiseaseSpanien