Clinical Trial: A Study to Evaluate the Potential Role of Mesenchymal Stem Cells in the Treatment of Idiopathic Pulmonary Fibrosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I Study to Evaluate the Potential Role of Mesenchymal Stem Cells in the Treatment of Idiopathic Pulmonary Fibrosis

Brief Summary:

The primary objective of this study is to establish the feasibility and safety of infusions of placental Mesenchymal Stem Cells (MSC) from related or unrelated HLA identical or HLA mismatched donors in the treatment of Idiopathic Pulmonary Fibrosis (IPF).

The secondary objectives are to document changes in lung function, 6 minute walk distance (6MWD), gas exchange and radiological appearance following infusion of MSC over a six month evaluation period.


Detailed Summary: This is a Phase I, open-label, single centre, non-randomized dose-escalation evaluation of the safety and feasibility of MSC treatment for subjects diagnosed with IPF. The first 4 patients will receive a dose of 1 x 10^6 placenta-derived MSC/kg. An interim safety analysis will be carried out by the Data Safety Management Board (DSMB) when these first 4 patients have all undergone their 3 month study visit. Should no serious adverse events be documented due, or likely due, to the MSC infusion, a subsequent 4 patients will receive an IV infusion of 2 x 10^6 placenta-derived MSC/kg. Therefore a total of up to eight (8) subjects who meet all eligibility criteria and who provide written informed consent will be enrolled in the study.
Sponsor: The Prince Charles Hospital

Current Primary Outcome: Number of Participants Who Demonstrated Acute Adverse Events Following Infusion [ Time Frame: 4 hours post-infusion ]

Acute adverse events following infusion was defined as the development of anaphalaxis and/or a 25% increase or decrease from baseline of hemodynamic measurements.


Original Primary Outcome: To provide evidence of safe delivery of MSC in doses as per protocol. [ Time Frame: 6 months post MSC infusion ]

Current Secondary Outcome:

  • Percentage Change in Lung Function as Assessed by FVC Compared to Baseline [ Time Frame: 6 months post MSC infusion ]
    Forced Vital Capacity (FVC) was measured and reported as a percentage of predicted and comapred from 6 months post-infusion to baseline
  • Percentage Change in 6 Minute Walk Distance Compared to Baseline [ Time Frame: Baseline and 6 months post MSC infusion ]
    At 6 months 6 Minute Walk Distance was mesured and compared as a percentage to baseline
  • Percentage Change in Lung Function as Assessed by DLCO Compared to Baseline [ Time Frame: 6 months post MSC infusion ]
    DLCO was measured as a percentage of predicted, and the percentage change between 6 months post-infusion and baseline is reported.


Original Secondary Outcome:

  • Evidence of improvement in or stabilisation of lung function (FVC, TLC, DLCO). [ Time Frame: Baseline and 6 months post MSC infusion ]
  • Evidence of improvement in or stabilisation of exercise capacity as assessed by 6MWD. [ Time Frame: Baseline and 6 months post MSC infusion ]
  • Evidence of improvement in or stabilisation of gas exchange as assessed by resting PaO2 and pulse oximetry during exercise testing. [ Time Frame: Baseline and 6 months post MSC infusion ]


Information By: The Prince Charles Hospital

Dates:
Date Received: May 4, 2011
Date Started: October 2010
Date Completion:
Last Updated: November 24, 2015
Last Verified: November 2015