Intraperitoneal transplant of Hepatocytes co-Encapsulated with mesenchymal stromal cells in modified alginate microbeads for the treatment of acute Liver failure in Pediatric patients (HELP)-An open-label, single-arm Simon's two stage phase 1 study protocol.
Emer FitzpatrickCeline FilippiBarath JagadisanDharshene ShivapathamHanish AnandMike LyneKatherine-Daisy StroudRebecca NewtonMarc DeLordAbdel DouiriAnil DhawanPublished in: PloS one (2023)
HMB002, if safe and efficacious in acute liver failure, could be a bridge until the liver regenerates or a suitable organ becomes available. There are multiple advantages to using HT. HT, when delivered by the intraperitoneal route, is less invasive than LT. Hepatocytes from a single donor liver can be used to treat multiple patients. Cryopreserved cells provide an off-the-shelf emergency treatment in PALF. When encapsulated, alginate encapsulation of hepatocytes precludes the need for immunosuppression unlike in LT.
Keyphrases
- liver failure
- hepatitis b virus
- study protocol
- randomized controlled trial
- end stage renal disease
- liver injury
- newly diagnosed
- ejection fraction
- public health
- emergency department
- induced apoptosis
- clinical trial
- drug induced
- healthcare
- prognostic factors
- bone marrow
- combination therapy
- peritoneal dialysis
- intensive care unit
- cell cycle arrest
- cell death
- patient reported outcomes
- open label
- umbilical cord