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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients.
The Prince Charles Hospital
Brisbane, Queensland, Australia
Number of Participants Who Demonstrated Acute Adverse Events Following 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.
Time frame: 4 hours post-infusion
Percentage Change in Lung Function as Assessed by FVC Compared to Baseline
Forced Vital Capacity (FVC) was measured and reported as a percentage of predicted and comapred from 6 months post-infusion to baseline
Time frame: 6 months post MSC infusion
Percentage Change in 6 Minute Walk Distance Compared to Baseline
At 6 months 6 Minute Walk Distance was mesured and compared as a percentage to baseline
Time frame: Baseline and 6 months post MSC infusion
Percentage Change in Lung Function as Assessed by DLCO Compared to Baseline
DLCO was measured as a percentage of predicted, and the percentage change between 6 months post-infusion and baseline is reported.
Time frame: 6 months post MSC infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.