Trial · NCT07890649
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Alveolar-arterial difference in oxygen tension (A-aDO2) | 24 weeks | The between-group difference in the change from baseline in the alveolar-arterial oxygen tension gradient (\[A-a\]DO₂) at Week 24, comparing the hBMMSC injection group with the placebo group. |
| Secondary | Diffusing capacity of the lungs for carbon monoxide (DLCO, % predicted) | 24 weeks/48 weeks | The between-group differences in the efficacy of hBMMSC injection versus placebo on the diffusing capacity of the lungs for carbon monoxide (DLCO, % predicted) at Weeks 24 and 48 after treatment |
| Secondary | PaO₂ | 24 weeks/48 weeks | The between-group differences in PaO₂ at Weeks 24 and 48 after treatment, comparing the hBMMSC injection group with the placebo group |
| Secondary | Oxygenation index | 24 weeks/48 weeks | The between-group differences in oxygenation indexat Weeks 24 and 48 after treatment, comparing the hBMMSC injection group with the placebo group |
| Secondary | Oxygen therapy requirements | 24 weeks/48 weeks | The between-group difference in oxygen therapy requirements at Weeks 24 and 48 after treatment, comparing the hBMMSC injection group with the placebo group |
| Secondary | Disease severity score (DSS) | 24 weeks/48 weeks | The between-group differences in disease severity score (DSS) at Weeks 24 and 48 after treatment, comparing the hBMMSC injection group with the placebo group.Disease Severity Score (DSS) is a scoring system used to evaluate disease severity based on predefined clinical signs, symptoms, or pathological changes. a higher DSS indicates more severe disease, whereas a lower DSS indicates milder disease, with 0 typically representing no detectable disease. |
| Secondary | 6-minute walk test (6MWT) | 12/24/48 weeks | The between-group differences in the 6-minute walk test (6MWT) results at Weeks 12, 24, and 48 after treatment, comparing the hBMMSC injection group with the placebo group |
| Secondary | Cardiopulmonary exercise testing (CPET) | 12/24/48 weeks | The between-group differences in the cardiopulmonary exercise testing (CPET) results at Weeks 12, 24, and 48 after treatment, comparing the hBMMSC injection group with the placebo group |
| Secondary | Forced vital capacity (FVC) | 4/24/48 weeks | The between-group differences in forced vital capacity (FVC) at Weeks 4, 24, and 48 after treatment, comparing the hBMMSC injection group with the placebo group |
| Secondary | Forced expiratory volume in 1 second (FEV₁) | 4/24/48 weeks | The between-group differences in forced expiratory volume in 1 second (FEV₁) at Weeks 4, 24, and 48 after treatment, comparing the hBMMSC injection group with the placebo group |
| Secondary | Pulmonary lesions assessed by imaging | 24/48 weeks | The between-group difference in changes in pulmonary lesions assessed by imaging at Weeks 24 and 48 after treatment, comparing the hBMMSC injection group with the placebo group |
| Secondary | Proportion of patients whose disease progressed to requiring whole-lung lavage (WLL) during the study period and the interval to WLL | 96 weeks | The between-group difference in the proportion of patients whose disease progressed to requiring whole-lung lavage (WLL) during the study period and the interval to WLL, comparing the hBMMSC injection group with the placebo group |
| Secondary | Medical Research Council (mMRC) dyspnea scores | 4/12/24 weeks | The between-group differences in modified Medical Research Council (mMRC) dyspnea scores at Weeks 4, 12, 24, and 48 after treatment, comparing the hBMMSC injection group with the placebo group. Modified Medical Research Council (mMRC) Dyspnea Scale is a questionnaire used to assess the severity of breathlessness and its impact on daily activities, particularly in patients with chronic obstructive pulmonary disease (COPD). The score ranges from 0 to 4, with Grade 0 indicating breathlessness only during strenuous exercise and Grade 4 indicating severe breathlessness that limits leaving the house or dressing. A higher mMRC score indicates more severe dyspnea and greater activity limitation |
| Secondary | St. George's Respiratory Questionnaire (SGRQ) scores | 4/12/24/48 weeks | The between-group differences in St. George's Respiratory Questionnaire (SGRQ) scores at Weeks 4, 12, 24, and 48 after treatment, comparing the hBMMSC injection group with the placebo group. The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific questionnaire used to assess health-related quality of life in patients with respiratory diseases. The total score ranges from 0 to 100, where higher scores represent worse respiratory health status and greater impairment of quality of life. |
| Secondary | The safety of hBMMSC injection | 24/48 weeks | The safety of hBMMSC injection compared with placebo during Weeks 24 and 48, as assessed by the incidence of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), important adverse events, and discontinuations due to AEs. |
| Secondary | The proportion of patients with an improvement from baseline in [A-a]DO₂ | 24/48 weeks | The proportion of patients with an improvement from baseline in \[A-a\]DO₂ at Weeks 24 and 48 after treatment |
| Secondary | The proportion of patients with an improvement from baseline in DLCO | 24/48 weeks | The proportion of patients with an improvement from baseline in DLCO at Weeks 24 and 48 after treatment |
| Secondary | The incidence of AEs and SAEs | 48 weeks | The incidence of AEs and SAEs through Week 48 after treatment |
| Secondary | The proportion of patients with improvements from baseline in PaO₂ | 24/48 weeks | The proportion of patients with improvements from baseline in PaO₂ at Weeks 24 and 48 after treatment |
| Secondary | The proportion of patients with improvements from baseline in oxygenation index | 24/48 weeks | The proportion of patients with improvements from baseline in oxygenation index at Weeks 24 and 48 after treatment |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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