Allogeneic cell therapy for the treatment of liver disease.
The scarcity of human organs available for transplantation is clearly evident. Efforts to maximize the use of available organs and to increase the number of donors have increased the number of transplantations performed, but at a rate that remains far behind the rate of growth of the waiting list. Thus, the likelihood of a patient with severe liver disease receiving a liver replacement is decreasing. In order to offer treatment to most patients with liver disease, alternatives to whole-organ replacement must be found. Cell-based treatments, in which suspensions of liver cells are injected into patients with liver failure and reconstitute the patient's liver functions, may be that alternative. Here, we report on a regulatory-compliant process for the production of a cryopreserved cell therapy product that yields viable, metabolically active hepatocytes that can be infused directly into patients with the goal of reconstituting liver function.
Ludlow
John W
JW
Vesta Therapeutics, Durham, NC, USA.
Bruce
Andrew T
AT
Kulik
Michael J
MJ
Meheux
Sonya O
SO
McCoy
Darell W
DW
Asfeldt
Thomas M
TM
D002469:Cell Separation / Q000379:methods; D002470:Cell Survival; D017690:Cell Transplantation / Q000379:methods; D017321:Clinical Trials, Phase I as Topic; D003374:Coumarins / Q000378:metabolism; D015925:Cryopreservation / Q000379:methods; D000939:Epitopes; D005434:Flow Cytometry / Q000379:methods; D022781:Hepatocytes / Q000378:metabolism / Q000637:transplantation*; D006801:Humans; D017093:Liver Failure / Q000628:therapy*; D018579:Patient Selection; D020858:Tissue and Organ Harvesting / Q000379:methods; D009927:Tissue and Organ Procurement; D014184:Transplantation, Homologous / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration; D014508:Urea / Q000378:metabolism
D003374:Coumarins; D000939:Epitopes; C017299:7-ethoxycoumarin; D014508:Urea