Clinical Trial: Study of Autologous Mesenchymal Stem Cells to Treat Idiopathic Pulmonary Fibrosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Treatment of Idiopathic Pulmonary Fibrosis With Bone Marrow Derived Mesenchymal Stem Cells

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 Summary:
Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Current Primary Outcome: Number of participants with adverse side effects. [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Efficacy of the infusion of mesenchymal stem cells in stopping the fall in pulmonary function in patients with mild to moderate IPF [ Time Frame: 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%.


Original Secondary Outcome: Assess the efficacy of the infusion of mesenchymal stem cells in stopping the fall in pulmonary function in patients with mild to moderate IPF [ Time Frame: 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%.


Information By: Clinica Universidad de Navarra, Universidad de Navarra

Dates:
Date Received: August 1, 2013
Date Started: March 2013
Date Completion: December 2017
Last Updated: January 5, 2017
Last Verified: January 2017