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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Front+Pharmacol
2017 ; 8
(ä): 549
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A Pilot Study Evaluating the Safety of Intravenously Administered Human Amnion
Epithelial Cells for the Treatment of Hepatic Fibrosis
#MMPMID28878671
Lim R
; Hodge A
; Moore G
; Wallace EM
; Sievert W
Front Pharmacol
2017[]; 8
(ä): 549
PMID28878671
show ga
Liver cirrhosis is the 6th leading cause of death in adults aged 15-59 years in
high-income countries. For many who progress to cirrhosis, the only prospect for
survival is liver transplantation. While there is some indication that
mesenchymal stem cells may be useful in reversing established liver fibrosis,
there are limitations to their widespread use - namely their rarity, the need for
extensive serial passaging and the associated potential for genomic instability
and cellular senescence. To this end, we propose the use of allogeneic amnion
epithelial cells. This clinical trial will assess the safety of intravenously
delivered allogeneic human amnion epithelial cells (hAECs) in patients with
compensated liver cirrhosis. This will also provide clinical data that will
inform phases 2 and 3 clinical trials with the ultimate goal of developing hAECs
as a therapeutic option for patients with cirrhosis who are at significant risk
of disease progression. We will recruit 12 patients with compensated cirrhosis,
based on their hepatic venous pressure gradient, for a dose escalation study.
Patients will be closely monitored in the first 24 h post-infusion, then via
daily telephone interviews until clinical assessment on day 5. Long term follow
up will include standard liver tests, transient elastography and hepatic
ultrasound. Ethics approval was obtained from Monash Health for this trial
16052A, "A Pilot Study Evaluating the Safety of Intravenously Administered Human
Amnion Epithelial Cells for the Treatment of Liver Fibrosis, A First in Adult
Human Study." The trial will be conducted in accordance to Monash Health Human
Ethics guidelines. Outcomes from this study will be disseminated in the form of
conference presentations and submission to a peer reviewed journal. This trial
has been registered on the Australian and New Zealand Clinical Trials Registry
ACTRN12616000437460.