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Study of IMMUNOSTEM gene therapy using modified stem cells for newly diagnosed patients with type 1 diabetes who still produce insulin

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 clinical trial focuses on treating Type 1 diabetes using a new gene therapy approach. The treatment involves using the patient's own hematopoietic stem and progenitor cells (blood-forming stem cells) that are modified in a laboratory. These cells are altered using a special carrier called a lentiviral vector to introduce a gene that produces a protein known as human programmed death-ligand 1. This treatment is called IMMUNOSTEM.

The main purpose of this study is to evaluate if this new treatment is safe for patients who have been recently diagnosed with Type 1 diabetes and still have some functioning insulin-producing cells. The treatment is given as a single intravenous injection of the modified cells back into the patient's body.

During the study, patients will be monitored closely for any side effects and changes in their diabetes condition. The monitoring includes regular blood tests, checking blood sugar levels, and measuring how well the body is producing insulin. The study will track how the modified cells perform in the body and observe any changes in the patient's need for insulin treatment over time.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your eligibility for the study will be assessed based on specific criteria, including:

    - Age between 18 and 40 years

    - Recent diagnosis of type 1 diabetes (within 180 days of first insulin use)

    - Presence of at least 2 diabetes-related antibodies in your blood

    - Specific blood sugar control measurements

  2. Step 2

    Cell collection procedure

    A procedure will be performed to collect stem cells from your blood

    These cells will be modified in a laboratory to include a special protein called PD-L1

    The modified cells will be prepared as a suspension for injection

  3. Step 3

    Treatment administration

    The modified cells will be given back to you through an intravenous injection

    This is a one-time treatment administration

  4. Step 4

    Follow-up period

    Regular monitoring will occur over 24 months to assess:

    - Safety through vital signs and laboratory tests

    - Blood sugar control through continuous monitoring

    - Insulin requirements

    - Blood tests to measure the presence of modified cells

    The total duration of the study is from August 2025 to August 2029

  5. Step 5

    Testing procedures

    Throughout the study period, you will undergo:

    - Regular blood tests

    - Mixed meal tolerance tests to measure your body's insulin production

    - Continuous blood sugar monitoring

    - Regular health assessments

Who can join the trial?

9 criteria

  • You must be able to understand and sign an informed consent form
  • You can be either male or female
  • Your age must be between 18 and 40 years old
  • You must be able to follow all study procedures throughout the entire duration of the study
  • You must have been recently diagnosed with Type 1 diabetes (within 180 days of starting insulin treatment)
  • Your HbA1c (blood test that measures average blood sugar levels over the past 2-3 months) must be between 53 and 150 mmol/mol
  • You must test positive for at least 2 autoantibodies (proteins in your blood that indicate your immune system is attacking insulin-producing cells)
  • Your C-peptide (a substance released with insulin that shows how much insulin your body produces) must be either:
    • At least 0.2 nmol/L or 0.6 ng/mL when measured at rest, or
    • At least 0.2 nmol/L or 0.6 ng/mL during a special meal test (if your resting level is lower)

Who cannot join the trial?

14 criteria

  • Persons who have not been diagnosed with Type 1 diabetes
  • Children under 18 years of age
  • Pregnant or breastfeeding women
  • Persons with severe allergic reactions in the past
  • Participation in other clinical trials within the last 30 days
  • Persons with serious medical conditions that could interfere with the study (such as severe heart, liver, or kidney problems)
  • People unable to provide informed consent
  • Persons with a history of non-compliance with medical treatments
  • Those with unstable mental health conditions
  • People with conditions that might affect their ability to follow study procedures
  • Individuals taking medications that could interact with the study treatment
  • Those with uncontrolled blood sugar levels (extremely high or low glucose readings)
  • People with severe complications from diabetes
  • Those who cannot commit to regular study visits and follow-up appointments
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Investigated drugs

Autologous hematopoietic stem and progenitor cells (HSPCs) are cells taken from the patient's own body, specifically from their bone marrow or blood. In this trial, these cells are modified in a laboratory using a special genetic technique. This is not a traditional medication, but rather a cell therapy using the patient's own modified cells. Lentiviral vector (LVV) is a tool used to modify the patient's cells. It's designed to deliver genetic material that helps the cells produce a protein called PD-L1, which plays a role in controlling immune responses. This is not taken as a medication but is used in the laboratory to prepare the cell therapy. These modified cells are intended to help treat type 1 diabetes by potentially protecting the remaining insulin-producing cells in the pancreas from being destroyed by the immune system.

What is already known about the treatment

Autologous HSPCs with PD-L1 modification – This is an investigational cell therapy that uses the patient's own hematopoietic stem and progenitor cells (HSPCs), which are genetically modified using a lentiviral vector to express human programmed death-ligand 1 (PD-L1). The therapy is administered through intravenous infusion and is currently being studied in Phase I/II clinical trials for treating newly diagnosed Type 1 diabetes patients who still have some remaining beta cell function. The treatment works by potentially modulating the immune response through the PD-L1 pathway, which may help protect insulin-producing beta cells from autoimmune destruction. This experimental therapy belongs to the class of cell and gene therapies, combining stem cell treatment with genetic modification to address the autoimmune component of Type 1 diabetes.

Investigated diseases

Type 1 diabetes - A chronic autoimmune condition where the body's immune system attacks and destroys insulin-producing beta cells in the pancreas. This results in the body being unable to produce sufficient insulin, which is essential for controlling blood sugar levels. The condition typically develops during childhood or adolescence, but can occur at any age. People with Type 1 diabetes experience high blood sugar levels, and their bodies cannot properly convert glucose from food into energy. The disease progresses as more beta cells are destroyed over time, leading to complete or near-complete dependency on external insulin. Common symptoms include increased thirst, frequent urination, extreme hunger, unintended weight loss, and fatigue.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2025-521304-21-00Protocol codeImmunostemEstimated enrolment15 patientsSponsorAltheia Science S.r.l.

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