Longitudinal outcomes of patients enrolled in a phase Ib clinical trial of the adipose-derived stromal cells-stromal vascular fraction in idiopathic pulmonary fibrosis.
Ntolios P., Manoloudi E., Tzouvelekis A., Bouros E., Steiropoulos P., Anevlavis S.
Clinical Trial with a reported sample of 14, published in Clin Respir J (2018) — summary generated from the PubMed abstract.
Several human studies show positive signals, while research methods and sample sizes continue to develop.
- Level A · Stronger Clinical Evidence
- Level B · Emerging clinical evidence with positive signals
- Level C · Early human research exploring benefits
- Level D · Scientific groundwork from lab and animal studies
- Emerging · Emerging topic under active research
This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.
- Study type
- Clinical Trial
- Journal
- Clin Respir J (2018)
- Country
- England
- Reported sample size
- 14
- Source database
- PubMed
- PMID
- 29412521
- DOI
- 10.1111/crj.12777
- Citations
- 44
Abstract (original English)
Background and objective Cell-based therapies have been used for the management of several diseases, holding promising results. Few studies have evaluated their use in chronic lung diseases. Idiopathic pulmonary fibrosis (IPF) remains a lethal disease although new therapies have emerged the recent years. We have recently published a phase I study of 14 patients receiving endobronchially adipose-derived stem cells (ADSCs). The aim of this report is to assess the outcome for our patients' population. Patients and methods Patients who originally participated in this phase I study were followed up until the time of death. Pulmonary function tests as well as disease progression and survival time points were recorded. Results After first administration, a significant functional decline was observed as assessed by the changes (delta-Δ) of diffusion capacity for carbon monoxide (DLco) (mean ΔDLco = 6.2%, P = .04) and forced vital capacity (FVC) (mean ΔFVC = 6%, P = .029) at 18 and at 24 months, respectively. Median overall progression-free survival was 26 months and median overall survival was 32 months. All patients were alive for at least 2 years (survival rate, 100%) after first administration. Twelve patients (85.7%) died owing to disease progression. None of the patients experienced tumor development. Conclusions Significant functional decline occurred at 24 months after first adm
What this study does not prove
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
Evidence level
Several human studies show positive signals, while research methods and sample sizes continue to develop.
How we grade evidenceBrowse all related research
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