Zurich, Switzerland, 4. December 2019
Chronic liver cirrhosis, mainly caused by Hepatitis B and C, has for long been a huge problem without any option for treatment.
However, Baermed Liver Cell Technologies has developed the HMI treatment, which are "mini-livers" retrieved from a patient’s own body.
The addressable market for the HMI treatment is calculated at over $25 billion in Asia and Europe alone.
This treatment has been fully developed and is currently the only option (apart from liver transplantation) to treat liver cirrhosis.
Partnerships in Asia and Europe are being evaluated by Strategic Swiss Partners and Baermed to complete phase II studies, register the matrix and make the treatment widely available.
Chronic liver cirrhosis is one of the top causes of death, worldwide.
Number of patients dying of liver cirrhosis
Cirrhosis is a chronic liver disease. It occurs when scar tissue replaces healthy liver tissue, and then stops the liver from working normally.
A total of one million people die from liver cirrhosis annually. Asia is the most affected area, with China, India and Indonesia being the leading countries.
The most common causes of cirrhosis are Hepatitis B, C, and other viruses. The prevalence of hepatitis in Asia and the Middle East is very high with roughly 400 million patients. Around 30% will develop cirrhosis sooner or later. In some countries the prevalence even exceeds 10% of the population.
Cirrhosis can also be caused by alcohol abuse and non-alcoholic fatty liver disease. Fatty liver is caused by conditions such as obesity and usually high cholesterol and triglycerides, as well as high blood pressure.
Infection prevention programmes are being implemented and will have a positive impact on the occurrence of cirrhosis in roughly 20 years' time.
However, with more countries embracing modernisation, alcohol abuse and obesity are more common. This means that liver cirrhosis remains an important disease that requires treatment.
Often, cirrhosis is first detected through a routine blood test or checkup. Liver cirrhosis hardly has any symptoms.
Thus, cirrhosis is often only detected at a late stage of liver fibrosis (scarring), and often too late, where significant scar tissue has caused irrecoverable liver damage.
As long as the cirrhosis is compensated, patients can survive for up to 12 years.
If decompensation occurs with additional symptoms like ascites and esophageal varices, the median survival of patients is only about 1.6 years.
The only possibility to treat de-compensated liver cirrhosis is full liver organ transplantation.
However, there is a shortage of donor organs and entry conditions to the transplantation lists are very strict.
The total number of annual global liver transplantations is 25,000. This means that roughly 99% of patients cannot be treated; the waiting list is long and many patients die before transplantation.
Treatment in an earlier stage could enhance and save many lives.
Currently, no other treatment to cure this disease is available. To slow the progression of symptoms and complications, measures like weight management, treatment for high blood pressure and less alcohol consumption are being recommended.
In his abdominal surgery practice, Swiss Professor Hans U. Baer, like all other surgeons and hepatologists, saw many patients with chronic liver cirrhosis dying without being able to offer an effective treatment.
He has always been passionate about finding a solution for these patients.
Professor Hans U. Baer has established a unique method of creating and implanting "mini livers" in patients with chronic liver cirrhosis. This procedure is called the Hepatocyte Matrix Implant (HMI) procedure. In short, a small piece of the patient’s own liver tissue is removed.
Then, in a specialised laboratory, the healthy liver cells are separated and seeded onto a unique growth-enhancing matrix. Under optimised conditions the liver cells start to grow.
The selection and preparation of cells, matrix, culturing and implantation have been optimised over many years. This has resulted in the highest yield of cells from extracted liver tissue, a high stimulation of cell growth and a high number of implanted cells.
After three days the cells are re-implanted in the patient’s small bowel mesentery. These "mini livers" take over a part of the function of the original liver.
Research also suggests that these "mini livers" signal to the liver and help with the recovery process. Recovery after the operation takes only 14 days.
In contrast to a liver transplant, no life-long medication is needed, because the cells are taken from the patient’s own body.
The Swiss HMI treatment may not only improve quality of life and stamina, but also help patients lead a normal, productive and prolonged life with their families.
On top of this, it could restrict the need for a liver transplantation, or serve as an alternative. The cost of the HMI procedure is around 15% of that for a liver transplantation.
In 2005, Professor Hans U. Baer implanted the first ever HMI implant in a human. Since then, a multitude of animal trials and first trials in humans have proven the feasibility and safety of the treatment.
Over 80 patients have already been treated. Clinical Phase I trials have taken place in Germany and Indonesia, proving feasibility and showing encouraging results of efficacy.
Patients previously experiencing swollen legs, yellow eyes, fatigue, sleepiness and lack of stamina, could go back to work after treatment.
A 56-year-old man with large ascites was able to travel alone again and a 60-year-old woman with a history of gastro-intestinal bleeding and dizziness survived and live independently for five years.
A clinical Phase II trial with ethical approval from Indonesia's Ministry of Health, is being conducted to further prove the efficacy of the HMI procedure. So far, the results have been promising.
Patients in the treatment group, recorded feeling well while previous abnormal clinical values changed to normal values within six months. However, the health of patients in the control group without HMI deteriorated while their clinical values worsened. Currently, more patients are being recruited.
Also, a completely new research laboratory, accredited for biosafety level II, has been built in cooperation with Tarumanagara University Jakarta. Registration of the matrix and availability of the treatment is expected in 2021.
The Tarumanagara and Baermed Human Liver Cell Technology research laboratory in Jakarta.
In conclusion, the HMI treatment could improve and even save the lives of many patients with chronic liver cirrhosis.
Prof. Hans U. Baer, Baermed Liver Cell Technologies
Drs. Karin van Zuilen, SSP
Dr. Coert Huijbregsen, SSP