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Clinical Trial Phase I, open, multicentric, non randomized, study with escalating doses, to evaluate the safety and feasibility of treatment with mesenchymal stem cells in patients with diagnosis of idiopathic pulmonary fibrosis.
Primary endpoint: The aim is to evaluate the safety and feasibility of the endobronchial administration of mesenchymal autolog stem cells derived from bone marrow (BM-MSC)in patients with mild-to-moderate idiopathic pulmonary fibrosis.
Secondary endpoint:Assess the possible effect of the infusion of BM-MSC in stopping the fall of pulmonary function in patients with mild-to-moderate idiopathic pulmonary fibrosis.
Enrollment
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Inclusion criteria
Capacity for signing informing consent and express the willing to fulfill all the requirements of the study protocol during the study.
The patients should be, in the researcher opinion, capable to fulfill all the requirements of the trial.
Male or female patients, 30 to 80 years old, inclusive.
Diagnosis of idiopathic pulmonary fibrosis according to the following criteria, based on the ATS/ERS Guidelines:
i. High resolution CT (HRCT) showing definite findings for idiopathic pulmonary fibrosis (FPI): bibasal reticular opacities with minimal ground glass opacities.
ii. Absence of other known causes of FPI including toxicity from drugs, environmental exposure or connective tissue diseases.
iii. Pulmonary function tests showing ventilatory restrictive pattern and/or impaired gas exchange (FVC and/or DLCO <90% of predicted)
FVC ≥ 50% of predicted value with ratio of FEV1 to FVC ≥ 0.70.
DLco (corrected for hemoglobin) ≥ 35% predicted value.
Capability of performing a 6 minutes walk test at the time of inclusion.
Exclusion criteria
Any of the following:
Primary purpose
Allocation
Interventional model
Masking
17 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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