Study of Donor Specific Immunomodulatory Cells (DSIMC) for Patients with End-Stage Liver Disease Undergoing Liver Transplantation

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What is this study about?

This clinical trial is focused on patients with end-stage liver disease who are undergoing a liver transplantation using a deceased donor organ. The study is exploring a new treatment involving Donor specific immunomodulatory cells (DSIMC), which are a type of cell therapy. These cells are given as a solution for injection through an infusion. The purpose of the study is to evaluate the safety of this treatment approach, which aims to reduce the need for systemic immunosuppression, a common treatment to prevent organ rejection after transplantation.

Participants in the study will receive the DSIMC treatment after their liver transplant. The study will monitor the safety of this treatment over a period of 12 months. Additionally, researchers will assess how many patients can be completely weaned off immunosuppressive medications by 36 months after their transplant, while still maintaining optimal liver function. For those who cannot be completely weaned off, the level of immunosuppression they require will also be evaluated.

This trial is designed to help improve the outcomes for liver transplant patients by potentially reducing the long-term need for immunosuppressive drugs, which can have significant side effects. The study is expected to start recruiting participants in August 2024 and aims to conclude by September 2030.

1 joining the study

Upon joining the study, you will be required to provide written consent after reading and understanding the patient information.

Eligibility criteria include being an adult aged 18 years or above, having a medical indication for a deceased donor liver transplantation, and meeting specific health parameters such as a MELD score of less than 20 and a WBC count greater than 2.0 x10^9 Cells/L.

2 pre-transplantation phase

Before the liver transplantation, you will undergo standard medical evaluations to ensure readiness for the procedure.

This phase involves preparing for the transplantation surgery with a deceased donor organ.

3 transplantation and initial treatment

You will receive a liver transplant from a deceased donor.

Following the transplantation, you will begin treatment with donor specific immunomodulatory cells (DSIMC), which are administered as a solution for injection through an infusion.

4 post-transplantation monitoring

After the transplantation, your health and the function of the transplanted liver will be closely monitored.

The primary goal is to evaluate the safety of the treatment protocol over a period of 12 months.

5 long-term follow-up

You will be monitored for up to 36 months to assess the percentage of patients who can be completely weaned off immunosuppression while maintaining optimal liver function.

The level of immunosuppression in patients not completely weaned will also be evaluated at this time point.

Who Can Join the Study?

Patients who need a liver transplant from a deceased donor.
All genders can participate.
Must be an adult, 18 years or older.
Must have a MELD score of less than 20.
(MELD score is a number that helps doctors understand how severe liver disease is.)
Must have a Bar score of less than 9.
(Bar score is another measure used to assess liver disease severity.)
Must have a WBC count greater than 2.0 x 10⁹ Cells/L.
(WBC count refers to the number of white blood cells, which are important for fighting infections.)
Must be able to read and understand the patient information and give written consent to participate.

Who Cannot Join the Study?

Patients who are not undergoing a liver transplant with a deceased donor organ.
Patients who are not diagnosed with end-stage liver disease.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Karolinska University Hospital	Solna	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not yet recruiting	15.08.2024

Trial locations

Immunomodulatory Cell Therapy is a treatment that uses special cells to help the body accept a new organ, like a liver, after a transplant. These cells are designed to adjust the immune system so that it doesn’t attack the new organ. This therapy aims to reduce the need for other medications that suppress the immune system, which can have many side effects. By using these cells, the goal is to make the body more tolerant of the new organ naturally.

Investigated diseases:

Liver transplant

End-stage Liver Disease – End-stage liver disease is the final phase of chronic liver disease, where the liver can no longer perform its vital functions effectively. This condition often results from long-term damage due to factors like chronic hepatitis, alcohol abuse, or fatty liver disease. As the disease progresses, the liver tissue becomes scarred, leading to cirrhosis, which impairs blood flow and liver function. Patients may experience symptoms such as jaundice, fatigue, swelling in the abdomen and legs, and confusion. The liver’s inability to detoxify the blood and produce essential proteins can lead to complications like bleeding disorders and infections. In this stage, liver transplantation is often considered to replace the damaged liver with a healthy one from a donor.

Trial ID:

2024-514866-37-01

Protocol code:

1311

Trial Phase:

Phase II and Phase III (Integrated)

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Study of Donor Specific Immunomodulatory Cells (DSIMC) for Patients with End-Stage Liver Disease Undergoing Liver Transplantation

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