Types of Stem Cells to Treat Liver Disease
Researchers in Tehran, Iran, have completed a Phase I trial of autologous bone marrow-derived mesenchymal stem cells (MSCs) for treating decompensated liver cirrhosis. Mohamadnejad (et al, 2007) set out to investigate the ability of MSCs to lead to regression of liver fibrosis as had been previously demonstrated in animals and treated four patients during this trial. The patients’ own stem cells were harvested from their bone marrow and these stem cells were then infused into a peripheral vein, not directly into the liver circulation. Patients reported no side-effects of treatment and all patients reported improved quality of life following treatment. This small study is too small to give strong evidence of the safety or efficacy of stem cell transplants for liver disease however, although when combined with other studies contributes to a positive picture overall.
Mesenchymal Stem Cells
MSCs are also the focus of a Phase II clinical trial underway in China looking at liver failure caused by the hepatitis B virus (NCT01322906), another Phase I trial in Bologna for end-stage liver disease in twelve patients (NCT01025622), and a fairly unique trial already completed in Iran using pre-differentiated mesenchymal stem cells injected directly into the portal vein. The latter trial (NCT00420134) involved harvesting mesenchymal stem cells from the patients, culturing these stem cells in the laboratory to grow a population of hepatocytes and then using ultrasound to guide their injection into the liver’s circulatory system. This trial aimed to recruit thirty patients but no results have been published as yet regarding either the safety or the efficacy of the treatment. A clinical trial to take place at Imperial College London, in the UK, is currently on hold as their newly built facilities are awaiting the award of a Good Manufacturing Process (GMP) licence. This clinical trial is also looking at injecting stem cells directly in to the hepatic circulation, although they will be using undifferentiated autologous mesenchymal stem cells rather than hepatocytes to test the maximum dose of stem cells that can be tolerated by patients in the trial (NCT00655707).
Cord Blood Stem Cells for Liver Disease
Autologous stem cell transplant for liver disease is not the only focus of research however, with a number of trials looking at umbilical cord blood stem cells as potential regenerative therapies for liver cirrhosis. A Phase I clinical trial in Beijing (NCT01220492) is currently recruiting patients with liver cirrhosis for treatment with umbilical cord blood stem cells in light of the success achieved with autologous stem cell transplants. The researchers aim to treat sixty patients which would provide stronger evidence of safety, and possible efficacy, of the stem cell treatment for liver damage, with results anticipated later in 2011. Another clinical trial approaching the recruitment stage in China is a Phase I/II study using umbilical cord mesenchymal stem cells infused into the hepatic artery in patients with liver cirrhosis (NCT01224327). This trial’s recruitment aim is 50 patients and results are expected in early 2013 after the trial’s completion. Scientists at the Chinese Academy of Sciences are also using umbilical cord mesenchymal stem cells to treat liver disease in patients in another Phase I trial (NCT01233102). This time, the researchers are looking at recruiting 200 patients and carrying out long-term follow-up for up to two years after treatment, which will greatly assist in the assessment of such experimental techniques in comparison to short-term, low-powered trials.
Continue Reading –> Novel Sources of Stem Cells for Liver Disease
