Ongoing Clinical Trials for Chronic Hepatic Failure
There is currently 1 ongoing clinical trial for patients with chronic hepatic failure (also known as end-stage liver disease). This trial is investigating a new cell therapy approach designed to help liver transplant recipients by potentially reducing their long-term need for immunosuppressive medications.
Clinical trial locations
Study of Donor Specific Immunomodulatory Cells (DSIMC) for Patients with End-Stage Liver Disease Undergoing Liver Transplantation
This trial is being conducted in Sweden and focuses on patients who need a liver transplant from a deceased donor. The study is exploring whether a new type of cell therapy called Donor Specific Immunomodulatory Cells (DSIMC) can help reduce the need for traditional medications that suppress the immune system after transplantation.
Who can participate:
- Adults aged 18 years or older of all genders
- Patients requiring a liver transplant from a deceased donor
- Those with a MELD score of less than 20 (a measure of liver disease severity)
- Those with a Bar score of less than 9 (another assessment of liver disease severity)
- Patients with a white blood cell count greater than 2.0 x 10⁹ cells/L (white blood cells help fight infections)
- Individuals who can read, understand the patient information, and provide written consent
Who cannot participate:
- Patients not receiving a liver transplant from a deceased donor
- Those without a diagnosis of end-stage liver disease
- Patients outside the specified age range
- Members of vulnerable populations who may require special protection or care
What the trial involves:
The main goal of this study is to evaluate the safety of using DSIMC therapy after liver transplantation. The treatment involves giving patients specially prepared cells through an infusion after their transplant surgery. These cells are designed to help the body’s immune system accept the new liver without attacking it.
Researchers will monitor participants closely for 12 months to assess the safety of this approach. They will then continue following patients for up to 36 months to see how many can be completely taken off immunosuppressive medications while still maintaining good liver function. For those who cannot be completely weaned off these drugs, the study will evaluate what level of immunosuppression they still need.
The investigational treatment:
The treatment being tested is Immunomodulatory Cell Therapy. This therapy uses special cells designed to adjust how the immune system works, helping it accept the transplanted liver naturally. The goal is to reduce reliance on traditional immunosuppressive medications, which can have significant side effects. By using these cells, researchers hope the body will become more tolerant of the new organ on its own.
The study is expected to begin recruiting participants in August 2024 and aims to conclude by September 2030.
Summary
Currently, there is one clinical trial available for patients with chronic hepatic failure undergoing liver transplantation. This trial is being conducted in Sweden and represents an innovative approach to transplant medicine. Rather than focusing on new organ preservation techniques or surgical methods, this study explores cellular therapy as a way to improve long-term outcomes for transplant recipients.
The trial focuses specifically on patients receiving deceased donor liver transplants and aims to address one of the major challenges in transplantation: the lifelong need for immunosuppressive medications. These medications, while necessary to prevent organ rejection, can cause serious side effects and complications over time. The DSIMC approach being tested may offer a path toward reducing or even eliminating the need for these drugs while maintaining successful transplant outcomes.
Patients with chronic hepatic failure who are awaiting or considering liver transplantation may wish to discuss this trial with their healthcare providers to determine if participation might be appropriate for their situation.