LEADING THE FIELD IN LIVER CELL REGENERATION

UNIQUE SYSTEMS

The 3D tissue engineering systems developed by Human Autocell are unique in providing an environment that keeps cells differentiated and fully functional.

CLINICAL PROOF OF CONCEPT

Human Autocell has already demonstrated clinical proof of concept related to the accelerated treatment of liver cirrhosis. In addition, exciting possibilities to address liver-related diseases caused by hepatitis exist. The processes have been developed over the past 11 years in Human Autocell’s laboratories and tested successfully on 75 patients. A statistical clinical trial was performed, and the efficacy rate was way above what is normally seen in a new drug or treatment.

IMPROVED QUALITY OF LIFE

The patient’s disease progression was halted, and the majority of the patients experienced notably improved quality of life. People who have a life expectancy of 6 months or less have survived in the long term and are once more living a normal life. Clinical parameters show significant improvements compared to former stages of the disease. Biopsies of patient implants 10 months after implantation showed good vascularisation and full viability of the “neo-liver” cells.

HOW IT WORKS

Human Autocell’s proprietary matrix solution – Porocell™ – provides a unique, safe and patented autologous procedure to isolate vital liver cells and re-implant them.

3-D GRAFTING

The Porocell™ (biodegradable) matrix provides a 3-dimensional graft environment. Liver cells need a specific type of 3-dimensional environment to fully exert their metabolic function. In addition, the matrix must be completely biocompatible yet recognisable to the body so that quick vascularisation can occur. The Hepautocell matrix implant is shown to promote in vitro cell proliferation and the ability of the implanted cells to provide additional liver function.

IMPROVED PATIENT SURVIVAL RATES

This new liver is able to function fully and reaches a steady state and size sufficient to support the diseased liver enough to enable patient survival.

A tissue sample is excised and the healthy cells are isolated. Using ‘Scaffolding Technology’, the cells are seeded in vitro on the Porocell matrix. Seeding is rapid and takes 3 days before the matrix is implanted into the patient’s abdominal cavity.,

COMPELLING BENEFITS

Proven, safe, fast, arrests disease progression, improves quality of life, an easily deployed, cost-effective solution.

OVER 75 SUCCESSFUL HOSPITAL PROCEDURES

Proven: Proof of concept has been established with 75 successful hospital procedures.

Safe: Observed survival using Human Autocell’s Hepautocell treatment benchmarked against patients with a MELD score (Model End Stage Liver Disease) greater or equal to 10 is significantly higher than the mortality risk reported in the literature for comparable cirrhotic patients undergoing a surgical procedure.

Fast: Typically takes 72 hours from receipt of tissue sample to implantation, compared to years of waiting for a transplant.

Regeneration of healthy cells: On average, progression of cirrhosis is arrested. A biopsy of a Hepautocell patient after 10 months shows the formation of fully vascularised tissue and macroscopic observation indicates neo-liver formation.

ARRESTED CIRRHOSIS

For those patients reporting pre-procedure, one year post procedure, and 2 years post procedure the MELD values on average remained constant, providing a trend that the Hepautocell treatment can stop disease progression of cirrhosis development. In addition, for patients given the extracorporeal MARS® treatment (a relatively new bridge-to-transplant “liver dialysis” method), there is a short term improvement in INR values but only subsequent Human Autocell therapy gives lasting benefit.

Improved quality of life: Post-procedure, disease progression is halted. Of the 75 patients treated, a majority experienced a stable or improved quality of life 12 months post treatment. People who formerly were not able to perform simple tasks any more have survived in the long term and are living a normal life again. Clinical parameters remain in a range significantly improved over the initial disease stage.

PATENTED TECHNOLOGY

The proprietary, patented 3D tissue engineering systems developed by Human Autocell go beyond current approaches and are unique in providing an environment that keeps these cells differentiated and fully functional.

MULTIPLE PATENTS

Human Autocell owns and holds patented processes and global patents for this proprietary treatment. Patent protection exists in all major territories, with particular emphasis on Europe, the USA and China. Human Autocell thereby commands a leading position in the cutting-edge technology of 3D cell regeneration.

In addition, the company owns the procedures and validation methods for matrix manufacturing. The Porocell patented matrix is a 3D structure with round cavities of defined diameters. Pore sizes are controlled along a gradient with larger pores of 300-400 mm on one side and smaller pore sizes greater than 50 mm on the other matrix side. The matrix has a highly interconnected porosity of scaffold, which exceeds 95%, and is highly hydrophilic; sponge-like qualities allow absorption of cell-suspensions of up to 7-fold its own weight.

BIOCOMPATIBLE, CUSTOMISABLE

The scaffolds’ mechanical properties and biocompatibility are favourable, as they are designed not to be damaged during handling and during the patient’s normal activities and are also biodegradable.

The Scaffold can be customised to fit any form and shape. The base material is a biocompatible and biodegradable polymer internationally approved for implantation.

Finally, Human Autocell owns clinical proof of concept related to the accelerated treatment of liver cirrhosis with exciting possibilities to tap into multi-billion dollar unmet needs. The systems have been developed over the past 11 years in our laboratories and tested successfully on 75 patients.

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