Study of Autologous Mesenchymal Stem Cells to Treat Idiopathic Pulmonary Fibrosis

Phase 1

Completed

• Conditions: Idiopathic Pulmonary Fibrosis

• Registration Number: NCT01919827
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-08-01
• Study First Submitted QC: 2013-08-06
• Study First Posted: 2013-08-09
• Status Verified: 2018-05
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse side effects.	Up to 12 months	Number of participants with adverse side effects, and according to the level of severity: 1. Low level: Increase in cough, fever or skin reactions; 2. Medium level: Infections not requiring hospital admission, mild alterations of renal or liver function; 3. High level: Death or major side effects requiring hospitalization: 1. Worsening dyspnea with \>=10% reduction in forced vital capacity, reduction in arterial pressure oxygen \>= 10 mmHg and radiology progression between 3 months separated visits.; 2. Need for hospitalization due to respiratory failure requiring mechanical ventilation, worsening in gases exchange or lung infection.; 3. Carcinogenesis at 12 months after the endobronchial infusion of mesenchymal stem cells.

Secondary Outcome Measures

Name	Time	Method
Efficacy of the infusion of mesenchymal stem cells in stopping the fall in pulmonary function in patients with mild to moderate IPF	Up to 12 months	Measures of efficacy: 1. Fall in forced vital capacity as a continuous variable; 2. Progression of the disease defined by: Death, need for transplantation or deterioration in pulmonary function defined by fall in forced vital capacity (FVC) \> 10% or in lung diffusion capacity (DLCO) \> 15%.

Trial Locations

Locations (2)

Servicio de Neumología, Clínica Universidad de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Servicio de Neumología. Hospital Universitario de Salamanaca; 🇪🇸 Salamanca, Spain