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Dsimc

In the realm of organ transplantation, researchers are constantly seeking innovative ways to improve patient outcomes and reduce the need for long-term immunosuppression. A groundbreaking clinical trial is currently underway, investigating the use of Donor Specific Immunomodulatory Cells (DSIMC) in liver transplant patients. This article delves into the details of this promising cell-based immunotherapy and its potential to revolutionize post-transplant care.

Table of Contents

What is DSIMC?

DSIMC, which stands for Donor Specific Immunomodulatory Cells, is an innovative cell-based therapy being developed for patients undergoing liver transplantation[1]. This new treatment is designed to help patients with end-stage liver disease who are receiving a liver transplant from a deceased donor[1].

How DSIMC Works

DSIMC is a type of immunotherapy, which means it works with your body’s immune system. The goal of this treatment is to help your body accept the new liver while reducing the need for strong immunosuppressive drugs that are typically used after transplantation[1]. These cells are specifically designed to match the donor’s characteristics, which is why they’re called “donor-specific.”

Potential Benefits of DSIMC

The main potential benefit of DSIMC is that it may allow patients to reduce or even stop taking immunosuppressive medications after their liver transplant[1]. This is important because while these medications are necessary to prevent rejection of the new liver, they can have serious side effects when used long-term. By potentially reducing the need for these drugs, DSIMC aims to improve the quality of life for liver transplant recipients.

Current Clinical Trial

DSIMC is currently being studied in a clinical trial to evaluate its safety and effectiveness[1]. The trial, named “Cell-based immunotherapy in solid organ transplantation to minimize systemic immunosuppression,” is designed to include 18 patients. Here are some key points about the trial:

  • It’s specifically for patients with end-stage liver disease who are undergoing liver transplantation with a deceased donor organ.
  • The main goal is to evaluate the safety of using DSIMC after liver transplantation.
  • Researchers will also look at how many patients can stop taking immunosuppressive drugs 36 months after the transplant while maintaining good liver function.

Who is Eligible for the DSIMC Trial?

The trial has specific criteria for who can participate. Here are some of the main requirements[1]:

  • Patients must be adults (18 years or older)
  • They must need a liver transplant from a deceased donor
  • Their white blood cell count must be above a certain level (>2.0 x10^9 Cells/L)
  • They must be able to understand the information provided and give written consent

Some conditions that would prevent a person from participating include[1]:

  • Having acute liver failure
  • Complete blockage of the portal vein (a major blood vessel in the liver)
  • Needing a second liver transplant
  • Being pregnant or of childbearing age without a negative pregnancy test
  • Participating in another interventional study

Safety Evaluation

The primary focus of this trial is to evaluate the safety of DSIMC[1]. Researchers will closely monitor patients for 12 months after their liver transplant to ensure that the treatment is safe. This careful monitoring is a crucial part of developing any new medical treatment.

How DSIMC is Administered

DSIMC is given as a solution for injection[1]. This means it’s a liquid that’s injected into the body, likely through an infusion. An infusion is when medication is given slowly through a vein, usually using an IV drip. This method allows the cells to enter the bloodstream and circulate throughout the body.

Aspect Details
Trial Name Cell-based immunotherapy in solid organ transplantation to minimize systemic immunosuppression
Investigational Drug Donor Specific Immunomodulatory Cells (DSIMC)
Target Population Adult patients with end-stage liver disease undergoing liver transplantation
Primary Objective Safety evaluation of DSIMC tolerance induction protocol
Secondary Objective Determine percentage of patients achieving immunosuppression freedom at 36 months
Administration Solution for injection via infusion
Key Inclusion Criteria Age ≥18, WBC >2.0 x10^9 Cells/L, able to provide informed consent
Key Exclusion Criteria Acute liver failure, total portal vein thrombosis, liver re-transplantation

FAQ

  • What is DSIMC and how does it work? DSIMC stands for Donor Specific Immunomodulatory Cells. It's a cell-based immunotherapy designed to modulate the immune system of liver transplant recipients. The goal is to help the patient's body accept the new organ while minimizing the need for systemic immunosuppression.
  • Who is eligible for this clinical trial? The trial is open to adult patients (18 years or older) with end-stage liver disease who are undergoing liver transplantation with a deceased donor organ. Participants must have a white blood cell count above 2.0 x10^9 cells/L and be able to understand and provide written consent.
  • What are the main objectives of the DSIMC clinical trial? The primary objective is to evaluate the safety of the DSIMC tolerance induction protocol following deceased donor liver transplantation. A secondary goal is to determine the percentage of patients who can achieve freedom from immunosuppression at 36 months post-transplant.
  • How is DSIMC administered to patients? DSIMC is administered as a solution for injection via infusion. The exact details of the administration protocol are part of what's being studied in this clinical trial.
  • What are some exclusion criteria for this trial? Patients with acute liver failure, total thrombosis of the portal vein, or those undergoing liver re-transplantation are not eligible. Additionally, female patients of childbearing age must have a negative pregnancy test, and patients participating in other interventional studies are excluded.

Ongoing Clinical Trials on Dsimc

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

    Not yet recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

Glossary

  • DSIMC: Donor Specific Immunomodulatory Cells: A type of cell-based therapy designed to modulate the immune system of transplant recipients to help accept the new organ.
  • Immunosuppression: The intentional prevention or reduction of the body's immune response, often necessary after organ transplantation to prevent rejection of the new organ.
  • End-stage liver disease: Advanced liver dysfunction that can no longer be treated effectively with other methods, often requiring liver transplantation.
  • Deceased donor organ: An organ obtained from a person who has been declared brain dead or after cardiac death, as opposed to a living donor.
  • Cell-based immunotherapy: A type of treatment that uses cells of the immune system to fight diseases or modulate immune responses.
  • Tolerance induction: The process of training the immune system to accept a transplanted organ without the need for long-term immunosuppressive drugs.
  • Portal vein: A blood vessel that carries blood from the gastrointestinal tract, gallbladder, pancreas, and spleen to the liver.
  • Thrombosis: The formation of a blood clot inside a blood vessel, which can obstruct blood flow.

References

  1. http://clinicaltrials.eu/trial/study-of-donor-specific-immunomodulatory-cells-dsimc-for-patients-with-end-stage-liver-disease-undergoing-liver-transplantation/