Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
A Phase I Study to Evaluate the Potential Role of Mesenchymal Stem Cells in the Treatment of Idiopathic Pulmonary Fibrosis
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.
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. ;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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