Clinical Trials Logo

Clinical Trial Summary

This is a phase I, randomized, blinded, placebo-controlled 9 subjects pilot safety run-in followed by an additional 16 randomized subjects for a total of 25 subjects. In the pilot phase subjects will be randomized into three treatment groups of allogenic mesenchymal stem cells and in the randomized phase subjects will receive either allogenic mesenchymal stem cells or matched placebo.


Clinical Trial Description

Idiopathic Pulmonary Fibrosis (IPF) is a progressive and debilitating lung disease characterized by interstitial fibrosis with decreasing lung volumes and pulmonary insufficiency eventually resulting in death. Patients with Idiopathic Pulmonary Fibrosis (IPF) typically present with complaints of sub acutely progressive dyspnea and non-productive cough, often accompanied by digital clubbing. Due to the insidious onset of symptoms, however, most patients are diagnosed at late stages of the disease after significant fibrosis has occurred. Physical exam is characterized by hypoxemia, "dry" inspiratory crackles on auscultation, and occasional digital clubbing (6). Pulmonary function tests (PFTs) usually reveal restrictive lung physiology with progressive decline of forced vital capacity (FVC), diffusion capacity (DLCO) and six-minute walk distances. Diagnosis is established by the pathologic finding of usual interstitial pneumonia (with sub epithelial fibroblastic foci) by open lung biopsy (7), and/or by high resolution CT (HRCT) demonstrating the characteristic findings of peripheral/basal sub pleural reticulonodular changes with fibrosis, honeycombing, and traction bronchiectasis (8, 9). The prognosis for patients with Idiopathic Pulmonary Fibrosis (IPF) is uniformly poor. The natural history of the disease is characterized by inexorable progressive decline interspersed with "exacerbations" or periods of accelerated disease which are often fatal (5). There are no FDA approved treatment options for patients with Idiopathic Pulmonary Fibrosis (IPF) and thus no standard of care. In cases of patients under the age of 60 with limited comorbid disease, lung transplant may be offered. Patients with Idiopathic Pulmonary Fibrosis (IPF) receive empiric treatment, supportive care alone, and more recently, are offered enrollment in clinical trials. The pathogenesis of Idiopathic Pulmonary Fibrosis (IPF) is characterized by epithelial cell injury and activation with interstitial inflammation, fibroblast proliferation with extracellular matrix collagen deposition, and eventual loss of function. Because mesenchymal stem cells are known to home to sites of injury, inhibit inflammation, and contribute to epithelial tissue repair, their use has been suggested as a novel therapy for the treatment of Idiopathic Pulmonary Fibrosis (IPF). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02013700
Study type Interventional
Source University of Miami
Contact
Status Terminated
Phase Phase 1
Start date November 13, 2013
Completion date November 24, 2016

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04497831 - Morphine for Dyspnea in Pulmonary Fibrosis Phase 3
Recruiting NCT05119972 - Tolerability, Pharmacokinetics and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis (IPF) Phase 1/Phase 2
Completed NCT01718990 - Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis
Completed NCT00162760 - Treatment of Idiopathic Pulmonary Fibrosis With Thalidomide Phase 2
Terminated NCT04589260 - TD-1058 First-In-Human Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis Phase 1
Completed NCT04069143 - A Study to Evaluate the Safety, Tolerability, Kinetics and Repeatability of 18F-BMS-986327 Phase 1
Completed NCT03050255 - Short-term Effects of Supplemental Oxygen in Patients With IPF N/A
Recruiting NCT04598919 - Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis Phase 1/Phase 2
Completed NCT03981094 - A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants Phase 1
Completed NCT02758808 - Pulmonary Fibrosis Foundation Patient Registry
Not yet recruiting NCT05387785 - Study to Assess the Safety and Tolerability of ANG-3070 in Subjects With Idiopathic Pulmonary Fibrosis Phase 1
Recruiting NCT05938920 - Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Completed NCT02538536 - A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Completed NCT01371305 - STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Withdrawn NCT03720483 - Inhaled NAC in Treatment of IPF Phase 1/Phase 2
Recruiting NCT03478553 - The Genetics of Pulmonary Fibrosis
Completed NCT03650075 - To Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its PK Profile in Healthy Volunteers Phase 1
Recruiting NCT05975983 - Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis Phase 2
Completed NCT03832946 - A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Completed NCT02874989 - Targeting Pro-Inflammatory Cells in Idiopathic Pulmonary Fibrosis: a Human Trial Phase 1