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Safety of allogeneic adipocyte-derived mesenchymal stromal cells expressing CXCR4 and IL‑10 in steroid‑refractory or ruxolitinib‑refractory acute graft‑versus‑host disease

Verified siteInvestigationalNo placebo
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What is this trial about?

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

The study focuses on patients who have developed acute graft-versus-host disease, a condition that can occur after a bone‑marrow transplant when the donor’s immune cells attack the recipient’s body. In these patients the disease does not improve with standard medicines such as corticosteroids or the drug ruxolitinib, or they cannot receive ruxolitinib at all. The investigational treatment consists of a suspension of allogeneic adipose tissue derived mesenchymal stromal cells that have been genetically modified to produce two proteins, CXCR4 and IL-10. The cells are given by an intravenous infusion, meaning they are delivered directly into a vein.

The main aim of the trial is to determine whether this cell therapy is safe and well‑tolerated in the target patients. Participants will receive a series of infusions over several weeks and will be closely monitored for any side effects or serious reactions. Throughout the follow‑up period doctors will check the patients’ health with routine examinations and simple laboratory tests to see if the condition shows any signs of improvement. The term “allogeneic” means the cells come from a donor, while “mesenchymal stromal cells” are a type of cell that can help calm an overactive immune response. The added proteins, CXCR4 and IL‑10, are intended to guide the cells to the areas of inflammation and to further reduce immune activity.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial Visit and Consent

    You meet the study team, sign the consent form, and receive information about the purpose of the trial and what will be required of you.

    Your medical history and current condition are recorded to confirm that you meet the trial criteria.

  2. Step 2

    Baseline Assessments

    A series of clinical and laboratory tests are performed to evaluate the severity of your acute graft‑versus‑host disease and to establish baseline values for later comparison.

    These assessments may include blood tests, organ function checks, and documentation of any symptoms.

  3. Step 3

    First Intravenous Infusion of Modified Cells

    You receive an infusion of allogeneic adipocyte‑derived mesenchymal stromal cells that have been genetically modified to express CXCR4 and IL‑10.

    The cells are delivered through a vein (intravenous infusion) in a sterile cell suspension.

    The exact dose and volume are determined by the study protocol and are not specified in the public summary.

    Allogeneic means the cells come from a donor rather than from your own body.

  4. Step 4

    Immediate Post‑Infusion Monitoring

    After the infusion, you are observed for several hours in a clinical setting to detect any immediate reactions.

    Vital signs such as blood pressure, heart rate, and temperature are checked regularly.

  5. Step 5

    Safety Follow‑Up Visits

    You attend scheduled follow‑up visits during which the study team evaluates you for any serious adverse reactions, regardless of the number of infusions you have received.

    Both clinical examinations and laboratory tests are performed to monitor your overall health.

  6. Step 6

    Additional Infusions (If Required)

    The protocol may call for one or more additional infusions of the same cell product, administered in the same manner as the first infusion.

    Each additional infusion is followed by the same monitoring procedures described above.

  7. Step 7

    Efficacy Assessments

    Throughout the study, the response of your disease is evaluated using clinical observations and laboratory markers.

    These assessments help determine whether the treatment is having a beneficial effect on your acute graft‑versus‑host disease.

  8. Step 8

    Final Study Completion

    At the end of the trial period, a comprehensive evaluation is performed to summarize safety findings and any observed efficacy.

    You receive a final report of the study results that pertain to your participation.

Who can join the trial?

6 criteria

  • Have had a allogeneic stem cell transplant (a transplant using donor blood‑forming cells) from any donor type, using bone marrow, peripheral blood stem cells, or cord blood.
  • Any type of transplant preparation (non‑myeloablative, myeloablative, or reduced‑intensity conditioning) is allowed.
  • Be between 18 and 75 years old, male or female.
  • Have a diagnosis of acute graft‑versus‑host disease (aGVHD) of grade II to IV that started after the transplant; a tissue sample (biopsy) is helpful but not required.
  • Have aGVHD that did not improve or got worse while taking both steroids (corticosteroids) and the medicine ruxolitinib, or be unable to take ruxolitinib for medical reasons. This includes: a) worsening after at least 7 days of ruxolitinib; b) no improvement after at least 14 days of ruxolitinib; c) loss of response after an initial improvement; or being steroid‑refractory (no response after 3‑7 days of steroids) and having severe thrombocytopenia (platelet count < 20,000/mm³) or neutropenia (neutrophil count < 500/mm³) or any other condition that makes ruxolitinib unsuitable.
  • Female participants must meet one of the following: be postmenopausal for at least one year, have had a surgical procedure that makes them unable to become pregnant, use a highly effective method of contraception during the study, or agree to practice true abstinence in a way that fits their normal lifestyle.

Who cannot join the trial?

10 criteria

  • Having a blood‑related disease that is not under control after a transplant or that is getting worse at the time you join the study.
  • Being allergic (having a known hypersensitivity) to DMSO, a chemical used to preserve the study cells, or to any other ingredient in the medication being tested.
  • Testing positive on a PCR test (a laboratory test that looks for the virus’s genetic material) for COVID‑19 (SARS‑CoV‑2) within 10 days before receiving the cell infusion.
  • Being pregnant, breastfeeding, planning to become pregnant, or planning to donate eggs during the study period.
  • Having any unstable or uncontrolled medical problem that is not related to your main condition, such as a recent heart attack, severe heart failure, very high blood pressure, serious liver or kidney problems, or uncontrolled hormone or metabolic disorders. The doctor will decide if any condition makes the study unsafe or could affect the results.
  • Having an active infection that affects the whole body (systemic infection) at the time of screening.
  • Being currently involved in another clinical trial, or having finished another trial less than three months ago.
  • Having ever taken part in an advanced‑therapy trial, such as a cell therapy, gene therapy, or tissue‑engineering study.
  • Having chronic hepatitis B (positive hepatitis B surface antigen) or hepatitis C infection confirmed by a PCR test, unless the hepatitis B core antibody is positive but the surface antigen is negative and no viral DNA can be detected.
  • Having a history of a positive test for HIV (human immunodeficiency virus).
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Investigated drugs

Allogeneic Adipose Tissue Derived Mesenchymal Stromal Cells (MSC) ectopically expressing CXCR4 and IL‑10
These are living cells taken from the fat tissue of a healthy donor. The cells are a type of stem cell called mesenchymal stromal cells. In the laboratory they are genetically altered so that they produce extra amounts of two proteins, CXCR4 and IL‑10. CXCR4 helps the cells travel to areas of inflammation, and IL‑10 is a natural substance that calms the immune system. In the trial the cells are suspended in a liquid and given to patients through an IV infusion. The purpose is to see if these specially‑modified cells can safely reduce the severe immune reaction called graft‑versus‑host disease in patients who have not responded to standard steroid treatments or to the drug ruxolitinib.

What is already known about the treatment

Allogeneic adipose tissue-derived mesenchymal stromal cells expressing CXCR4 and IL‑10 - The product is given as an intravenous infusion of a sterile cell suspension. It is still experimental and currently only being studied in early‑phase clinical trials, with no regulatory approval yet. It is intended for patients with acute graft‑versus‑host disease that does not respond to steroids or ruxolitinib. The cells are engineered to show the CXCR4 receptor, which helps them travel to inflamed tissue, and to produce the anti‑inflammatory protein IL‑10, reducing the immune attack; this therapy is classified as a gene‑modified mesenchymal stromal cell product.

Investigated diseases

Acute graft‑versus‑host disease - Acute graft‑versus‑host disease is an inflammatory condition that occurs when donor immune cells attack the recipient’s tissues after a stem cell or bone marrow transplant. It typically begins within the first 100 days post‑transplant and commonly involves the skin, liver, and gastrointestinal tract. The immune attack causes redness and rash on the skin, yellowing of the eyes or skin, and diarrhea or abdominal pain. In some patients the reaction does not improve with standard steroid therapy and can persist or worsen despite additional medications. Ongoing immune activity can lead to further tissue damage and organ dysfunction over time.
Trial detailsLast updated 7 Nov 2026
Age18+ yearsPhasePhase ITrial ID2025-523139-21-01Protocol code2G-MSC-GVHDEstimated enrolment15 patientsSponsorFundacion Instituto De Investigacion Sanitaria De Navarra

sourced from the EU Clinical Trials Register and site verification

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