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Study of Mesenchymal Stromal Cells expressing CXCR4 and IL-10 for patients with acute Graft Versus Host Disease who do not respond to steroids or ruxolitinib

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with acute Graft Versus Host Disease, a condition where transplanted immune cells attack the body's own tissues. This specific research is for patients whose condition has not responded well to corticosteroids, which are common anti-inflammatory medicines, or to ruxolitinib, a specific type of medication used to calm the immune system. The purpose of the study is to evaluate the safety and how well the body tolerates a new experimental treatment.

The treatment being tested consists of allogeneic adipose tissue derived mesenchymal stromal cells. These are special cells taken from fat tissue of a donor that have been modified in a laboratory to produce two specific proteins, CXCR4 and IL-10, which help manage immune responses. These modified cells are provided as a cell suspension for injection and are delivered through an intravenous infusion, which means the medicine is put directly into a vein.

During the study, participants will receive these cell infusions. Following the administration of the treatment, the medical team will monitor the participants closely over a period of time to observe any side effects or reactions to ensure the process is safe.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Administration of the test treatment

    The intravenous infusion (medicine delivered directly into a vein) of allogeneic adipose tissue derived mesenchymal stromal cells (specialized cells taken from fat tissue) is performed.

    These cells have been modified to express CXCR4 and IL10, which are specific proteins used to assist the body's response.

    The treatment is provided as a cell suspension for injection.

  2. Step 2

    Safety and efficacy monitoring

    The safety and tolerability of the treatment are monitored by observing for any serious adverse reactions (unexpected or harmful side effects) occurring during or after the infusions.

    The efficacy, or how well the treatment works, is evaluated through clinical and biological parameters (physical signs and laboratory tests).

Who can join the trial?

7 criteria

  • You must have had an allogeneic hematopoietic stem cell transplant (alloHSCT), which is a procedure where healthy blood-forming stem cells from a donor are given to a patient to replace damaged bone marrow. This can include stem cells from a matched unrelated donor, a sibling, or a half-matched donor, using bone marrow, blood, or cord blood.
  • You can have received any level of conditioning, which refers to the medical treatments, such as chemotherapy or radiation, used to prepare the body for a stem cell transplant.
  • You must be a male or female between the ages of 18 and 75 years.
  • You must have a clinical diagnosis of acute Graft-versus-Host Disease (GVHD), a condition where the transplanted immune cells attack the recipient's body, specifically at grades II to IV (moderate to severe stages).
  • Your acute GVHD must be refractory to corticosteroids (strong anti-inflammatory medicines) and ruxolitinib (a specific medication used to treat GVHD), meaning the disease has not responded to these treatments. Alternatively, you may be included if you are not able to take ruxolitinib.
  • For those not eligible for ruxolitinib, this includes patients whose disease continues to get worse despite steroid treatment, or those with very low blood counts, such as thrombocytopenia (a low number of platelets, which help blood clot) or neutropenia (a low number of white blood cells that help fight infection).
  • Female participants must either have gone through menopause for at least one year, have had a surgical procedure to prevent pregnancy, or agree to use highly effective contraception (methods to prevent pregnancy) or practice abstinence during the study.

Who cannot join the trial?

9 criteria

  • People with a blood disease that is currently getting worse or is not being managed by their recent transplant.
  • People who have tested positive for COVID-19 (using a test called PCR, which looks for the virus's genetic material) within 10 days before receiving the cell treatment.
  • Women who are pregnant, breastfeeding, or planning to become pregnant or donate eggs (ova) during the study or shortly after.
  • People with any unstable or uncontrolled health issues—such as problems with the heart, lungs, liver, kidneys, stomach, urinary system, blood clotting, immune system, hormones, or brain—that are not related to their main disease and could make the study unsafe or difficult to measure.
  • People who have a systemic infection, which is an infection spreading throughout the entire body, that is currently active.
  • People who are currently in a clinical trial or have finished one less than 3 months ago.
  • People who have ever participated in a trial involving advanced therapies, such as cell therapy (using living cells), gene therapy (changing genetic material), or tissue engineering (creating replacement tissues).
  • People with chronic hepatitis B (a long-term liver infection) or hepatitis C (another liver infection) that shows signs of active virus production in the blood.
  • People who have a history of testing positive for HIV, which is a virus that attacks the body's immune system.
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Investigated drugs

Allogeneic Adipose Tissue Derived Mesenchymal Stromal Cells (MSC) ectopically expressing CXCR4 and IL10 is a specialized cell therapy. This treatment uses stem cells taken from fat tissue of a donor. These cells have been genetically modified in a lab to produce two specific proteins, CXCR4 and IL-10, which are intended to help the cells work more effectively to treat graft versus host disease. The modified cells are delivered to the patient through an intravenous infusion.

What is already known about the treatment

Allogeneic adipose tissue derived mesenchymal stromal cells (MSC) ectopically expressing CXCR4 and IL10 - This treatment is administered as a cell suspension through an intravenous infusion into the bloodstream. Currently being studied in clinical trials, these specialized cells are taken from fat tissue and genetically modified to produce two specific proteins that help direct the cells to where they are needed and reduce inflammation. The medication works by using these proteins to home in on damaged tissues and calm an overactive immune system, making it a type of cell-based immunotherapy. It is being investigated as a way to treat patients suffering from severe acute graft versus host disease who have not responded to standard treatments.

Investigated diseases

Acute Graft-versus-Host Disease - This condition occurs when newly transplanted immune cells attack the recipient's healthy tissues. It most commonly affects the skin, liver, and gastrointestinal tract. The process begins when donor cells recognize the recipient's body as foreign and initiate an immune response. This reaction can progress rapidly, leading to inflammation and damage in various organ systems. In some cases, the condition does not respond to standard steroid medications or other specific therapies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-523139-21-00Protocol code2G-MSC-GVHDEstimated enrolment15 patientsSponsorFundacion Instituto De Investigacion Sanitaria De Navarra

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