Safety and Preliminary Efficacy of hUCMSC-EVs in Interstitial Lung Disease
1 maj 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
24
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Tong, M.D
- Telefonnummer: 86-13764089607
- E-post: tong.lin@zs-hospital.sh.cn
Studieorter
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-
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Shanghai, Kina
- Zhongshan hospital, Fudan university
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Kontakt:
- Tong, M.D
- Telefonnummer: 86-13764089607
- E-post: tong.lin@zs-hospital.sh.cn
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Huvudutredare:
- Yuanlin Song, M.D
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Lågdosgrupp
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hUCMSC-EVs , nebulized BID × 7d/cycle, 3 cycles
Nebulized inhalation BID × 7d per cycle, 3 cycles
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Experimentell: Högdosgrupp
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hUCMSC-EVs , nebulized BID × 7d/cycle, 3 cycles
Nebulized inhalation BID × 7d per cycle, 3 cycles
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Incidence and Severity of Adverse Events
Tidsram: From first dose to Week 12
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From first dose to Week 12
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from Baseline in Forced Vital Capacity (FVC)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
30 april 2026
Primärt slutförande (Beräknad)
30 april 2027
Avslutad studie (Beräknad)
30 september 2028
Studieregistreringsdatum
Först inskickad
17 april 2026
Först inskickad som uppfyllde QC-kriterierna
1 maj 2026
Första postat (Faktisk)
6 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ACE001-RI001
Läkemedels- och apparatinformation, studiedokument
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Nej
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