Safety and Preliminary Efficacy of hUCMSC-EVs in Interstitial Lung Disease
1. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
24
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Tong, M.D
- Telefonnummer: 86-13764089607
- E-post: tong.lin@zs-hospital.sh.cn
Studiesteder
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-
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Shanghai, Kina
- Zhongshan hospital, Fudan university
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Ta kontakt med:
- Tong, M.D
- Telefonnummer: 86-13764089607
- E-post: tong.lin@zs-hospital.sh.cn
-
Hovedetterforsker:
- Yuanlin Song, M.D
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Lavdosegruppe
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hUCMSC-EVs , nebulized BID × 7d/cycle, 3 cycles
Nebulized inhalation BID × 7d per cycle, 3 cycles
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Eksperimentell: Høydosegruppe
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hUCMSC-EVs , nebulized BID × 7d/cycle, 3 cycles
Nebulized inhalation BID × 7d per cycle, 3 cycles
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Eksperimentell: 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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Hva måler studien?
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
30. april 2026
Primær fullføring (Antatt)
30. april 2027
Studiet fullført (Antatt)
30. september 2028
Datoer for studieregistrering
Først innsendt
17. april 2026
Først innsendt som oppfylte QC-kriteriene
1. mai 2026
Først lagt ut (Faktiske)
6. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ACE001-RI001
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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