Medically reviewed by Dr. Younis Yaseen, Medical Director, Regenova BioTech. Last updated: November 2026.
Short answer: Stem cell therapy for liver cirrhosis and pulmonary fibrosis is still being tested, and no stem cell product is approved for either disease in the US or the EU. Some trials report better liver function or slower loss of lung function, while others found no benefit, so it is considered alongside standard treatment and never in place of it.
Cirrhosis and pulmonary fibrosis affect different organs, but they share one process: healthy tissue is slowly replaced by scar tissue that does not work. This guide explains what stem cell research shows for each disease, how it fits with the treatments that already exist, what the risks are, and what to ask before you consider it.
What liver cirrhosis and pulmonary fibrosis have in common
In cirrhosis, years of injury from hepatitis B or C, alcohol, fatty liver disease or other causes leave the liver full of scar tissue. As scarring grows, the liver makes less albumin and clotting proteins, and fluid, bleeding and confusion can follow. This later stage is called decompensated cirrhosis.
In pulmonary fibrosis, scar tissue builds up in the walls of the air sacs, so oxygen passes into the blood less easily. The most common form is idiopathic pulmonary fibrosis (IPF), which has no known cause. Doctors follow it with lung function tests, mainly forced vital capacity (FVC), which measures how much air you can breathe out.
How stem cells might help scarred organs
Most trials use mesenchymal stem cells (MSCs), taken from bone marrow, fat tissue or the umbilical cord. In laboratory studies, MSCs release growth factors and other signals that calm inflammation and slow the cells that lay down scar tissue. In the liver these are the hepatic stellate cells, and in the lungs the fibroblasts. MSCs also release tiny particles called extracellular vesicles, which carry proteins and genetic messages between cells and are now being studied as a cell-free treatment. Researchers are also working with liver progenitor cells and with liver-like cells grown in the lab, but these are still mostly at the research stage. None of these cells is expected to rebuild a liver or a lung. The aim in trials is to improve organ function or slow its decline. You can read more about the different cells in our guide to types of stem cells used in medicine.
Stem cell therapy for liver cirrhosis: what the trials show
Standard care comes first. It means treating the cause where possible (antiviral medicines for hepatitis B and C, stopping alcohol, managing weight and diabetes), treating complications, and liver transplantation for patients who qualify. Stem cell research looks at whether cells can add to this care.
Survival in decompensated cirrhosis (Hepatology International, 2021): in an open-label randomized trial of 219 patients with hepatitis B-related decompensated cirrhosis, those who received three umbilical cord MSC infusions plus standard care had a higher overall survival rate over up to 75 months than those on standard care alone. Albumin, bilirubin and clotting markers improved over 48 weeks. The rate of liver cancer did not differ between the groups, and no significant side effects were reported.
Pooled results (Stem Cell Research & Therapy, 2023): a review of 11 clinical trials found that MSCs raised albumin and lowered the MELD score, a measure of how severe liver disease is, within the first 6 months. None of the included studies reported severe adverse effects.
Placebo-controlled trial (Liver International, 2013): in 27 patients with decompensated cirrhosis, the patient's own bone marrow MSCs given through a vein made no difference to MELD score, liver function tests or liver volume at 12 months compared with placebo.
REALISTIC trial (Lancet Gastroenterology & Hepatology, 2018): in 81 UK patients with compensated cirrhosis, a different approach (a blood growth factor with or without infusions of the patient's own CD133 blood stem cells) did not improve liver function or fibrosis. Serious adverse events were more frequent in the group given stem cells: 43%, compared with 11–12% in the other groups.
These results do not agree with each other. The largest positive trial was open-label, which means patients and doctors knew who was treated, and it included only patients with hepatitis B. Larger controlled trials are still needed to show who benefits and by how much. The type of cell also matters, and the REALISTIC result shows that a cell treatment can add risk in liver disease.
Stem cell therapy for pulmonary fibrosis: what the trials show
Standard care for idiopathic pulmonary fibrosis includes antifibrotic medicines (nintedanib and pirfenidone), oxygen therapy, pulmonary rehabilitation and, for some patients, lung transplantation. In October 2025 the US FDA approved a third medicine, nerandomilast. In a trial of 1,177 patients with IPF, it slowed the loss of FVC by about 69 ml over one year compared with placebo. Its approval was extended to progressive pulmonary fibrosis in December 2025.
Stem cell trials in pulmonary fibrosis are smaller and earlier:
AETHER (Chest, 2017): 9 patients with mild to moderate IPF received a single infusion of donor bone marrow MSCs. This early safety trial found no treatment-related serious adverse events. Over 60 weeks, FVC as a percentage of the predicted value fell by 3.0% on average.
High-dose MSCs (Stem Cells Translational Medicine, 2020): 20 patients with rapidly worsening IPF received donor MSCs or placebo. After 12 months, FVC had risen by 7.8% in the MSC group and fallen by 5.9% in the placebo group. Deaths (two in each group) and the CT fibrosis score did not differ.
Inhaled cell-derived vesicles (Signal Transduction and Targeted Therapy, 2025): in an early placebo-controlled trial of 24 patients, nebulized vesicles made from umbilical cord MSCs were well tolerated, and patients improved in lung function and in breathing and cough questionnaires. These vesicles are released by stem cells and contain no living cells.
These studies are small, and none has yet confirmed the results in a large trial. In pulmonary fibrosis, the realistic aim of cell therapy is to slow the decline in lung function. CT scans in these trials have not shown scar tissue disappearing.
Is stem cell therapy approved for cirrhosis or pulmonary fibrosis?
No. The US FDA states that the only stem cell products it has approved are cord blood products for blood-forming disorders. The European Medicines Agency has not authorized any MSC product for liver or lung disease. In the EU, these treatments are given within clinical studies or under national rules for advanced therapies.
Who may be considered
Trials usually enrolled patients with a confirmed diagnosis and set limits on how advanced the disease could be. A doctor would usually look at:
For the liver: the cause of cirrhosis and whether it is controlled, recent blood tests (albumin, bilirubin, INR), the MELD or Child-Pugh score, ultrasound or elastography, and any history of bleeding, infection or liver cancer.
For the lungs: the type of fibrosis, a recent high-resolution CT scan, lung function tests (FVC and DLCO), oxygen needs, the 6-minute walk test and current medicines.
Other conditions, recent hospital stays and whether you are on a transplant list.
Cell therapy may not be suitable for patients with very advanced disease, an active infection or suspected cancer. In these situations, a responsible clinic will say so and point you back to your specialist or transplant team.
Risks and side effects
In the MSC trials described above, no serious treatment-related side effects were reported. Patients with cirrhosis are more prone to infection and bleeding, so they need careful assessment, and the REALISTIC trial reported more serious adverse events in the group given stem cells. Laboratory quality, the cell dose and the way cells are given all affect safety.
Questions to ask before any stem cell treatment for the liver or lungs
Which cells will be used, from which source, and in which laboratory are they prepared and tested?
How will the cells be given, and how many cells will I receive?
Which published studies support this treatment for my diagnosis and stage?
How will my current treatment continue, and will my specialist be informed?
Which tests will show whether it helped, and when will they be done?
What happens if I develop a fever, infection or other problem after I go home?
Frequently asked questions
Can stem cells reverse liver cirrhosis?
This has not been shown. Some trials report better liver function and one reported longer survival, but reversal of cirrhosis has not been proven, and some controlled trials found no benefit.
Can stem cell therapy cure pulmonary fibrosis?
No. Small trials suggest it may slow the loss of lung function in some patients, but CT scans in these trials have not shown scar tissue disappearing. Larger trials are still needed.
Should I stop my current medicines before stem cell therapy?
No. Antiviral medicines for hepatitis and antifibrotic medicines for the lungs have proven benefits. Any cell treatment is considered in addition to them, and only your doctors should change your medicines.
How are stem cells given for liver and lung disease?
In most trials, cells were given by intravenous infusion. Some liver trials delivered cells through the hepatic artery, and one recent lung trial used inhaled vesicles made from stem cells.
Is stem cell therapy approved for cirrhosis or lung fibrosis?
No. No stem cell product is approved for either disease by the US FDA or the European Medicines Agency. In the EU, such treatments are offered within clinical studies or under national rules.
Liver and lung assessment at Regenova BioTech
Regenova BioTech is a regenerative medicine clinic in Sofia, Bulgaria, inside the European Union. The clinic has a small laboratory on site, and cells are prepared in our main laboratory in Graz, Austria, which works under quality systems certified to ISO 9001 and ISO 20387 (biobanking). Every donor is screened for infections, and each batch of cells is tested for identity, viability and sterility before release, with a certificate of analysis that we can share with you and your doctor.
A program is planned in four steps:
Assessment: the cause and stage of your disease, blood tests, imaging and, for the lungs, lung function tests.
Choice of cells and route: usually mesenchymal stem cells given by intravenous infusion. The type of cells, dose and number of sessions depend on your case.
Treatment alongside your usual care: antiviral, antifibrotic and other medicines continue as your specialist prescribed them.
Follow-up: repeat blood tests and ultrasound or elastography for the liver, or lung function tests and CT for the lungs, so you and your doctors can see whether anything has changed.
Every program starts with a free review of your reports. For the liver, send recent blood tests and imaging. For the lungs, send your CT report and lung function tests. Our doctors tell you in writing whether a program may be suitable, what it can and cannot be expected to do, and what it would cost. If cell therapy is not right for you, we tell you that too. You can see all the conditions we assess, or read our patient guide to stem cell therapy in Bulgaria.
Send your reports for a free, no-obligation review via WhatsApp at +49 176 5689 1000 or through our contact form.
Read this article in Arabic: علاج تليف الكبد وتليف الرئة بالخلايا الجذعية.
This article is for general information and does not replace individual medical advice. Stem cell treatments do not work for every patient, and no result can be guaranteed. Medically reviewed by Dr. Younis Yaseen, Medical Director, Regenova BioTech.
References
Shi M, et al. Mesenchymal stem cell therapy in decompensated liver cirrhosis: a long-term follow-up analysis of the randomized controlled clinical trial. Hepatol Int. 2021;15:1431-1441. PubMed
Lu W, et al. Efficacy and safety of mesenchymal stem cell therapy in liver cirrhosis: a systematic review and meta-analysis. Stem Cell Res Ther. 2023;14:301. PubMed
Mohamadnejad M, et al. Randomized placebo-controlled trial of mesenchymal stem cell transplantation in decompensated cirrhosis. Liver Int. 2013;33:1490-1496. PubMed
Newsome PN, et al. G-CSF and autologous CD133-positive stem-cell therapy in liver cirrhosis (REALISTIC). Lancet Gastroenterol Hepatol. 2018;3:25-36. PubMed
Glassberg MK, et al. Allogeneic human mesenchymal stem cells in patients with idiopathic pulmonary fibrosis via intravenous delivery (AETHER). Chest. 2017;151:971-981. PubMed
Averyanov A, et al. First-in-human high-cumulative-dose stem cell therapy in idiopathic pulmonary fibrosis with rapid lung function decline. Stem Cells Transl Med. 2020;9:6-16. PubMed
Li M, et al. Clinical investigation on nebulized human umbilical cord MSC-derived extracellular vesicles for pulmonary fibrosis treatment. Signal Transduct Target Ther. 2025;10:179. PubMed
Richeldi L, et al. Nerandomilast in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2025;392:2193-2202. PubMed
Pulmonary Fibrosis Foundation: FDA approves nerandomilast for IPF
US FDA: Important patient and consumer information about regenerative medicine therapies
