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Study on the Effects of Autologous Bone Marrow-Derived Mononuclear Cells for Patients with Diabetic Foot Syndrome and Lower Limb Ischemia

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What is this trial about?

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

This clinical trial is focused on studying the effects of a new treatment for patients with chronic limb-threatening ischemia and diabetic foot ulcers. These conditions are serious complications often seen in people with diabetes, where there is poor blood flow to the lower limbs, leading to severe pain and ulcers that are difficult to heal. The treatment being tested involves using a special type of cell therapy called autologous bone marrow-derived mononuclear cells, also known by the code name REX-001. These cells are taken from the patient's own bone marrow and are injected back into the body to help improve blood flow and promote healing.

The purpose of the study is to compare the effects of this cell therapy with the standard treatment currently available for these conditions. Participants in the study will receive either the cell therapy or the standard treatment, and their progress will be monitored over time. The study aims to see if the cell therapy can improve tissue oxygenation, which is the amount of oxygen reaching the tissues, and lead to better healing of the ulcers, less pain, and a lower risk of needing major amputations.

Throughout the study, researchers will also look at the safety of the cell therapy by monitoring any side effects that occur. Participants will be asked to provide feedback on their experience with the treatment through questionnaires. The study will also explore how the quality of the cell suspension used in the therapy relates to improvements in blood flow and healing. The trial is expected to continue until the end of 2027, providing valuable insights into the potential benefits of this innovative treatment approach for patients with these challenging conditions.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of diabetic foot ulcers or status after minor amputation, and chronic limb-threatening ischemia due to arterial occlusive disease.

    Eligibility criteria include being between 18 and 90 years old, having type 1 or type 2 diabetes, and providing signed informed consent.

  2. Step 2

    Treatment preparation

    The treatment involves the use of a suspension of autologous mononuclear cells derived from the patient's own bone marrow.

    These cells are prepared for intramuscular injection as part of the therapy.

  3. Step 3

    Treatment administration

    The prepared cell suspension is administered through intramuscular injection.

    The aim is to improve tissue oxygenation and clinical outcomes in patients with chronic limb-threatening ischemia and diabetic foot ulcers.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the effects of the treatment. This includes measuring tissue oxygenation and evaluating wound healing, pain changes, and the rate of major amputation.

    Safety is monitored by recording any adverse events, both expected and unexpected.

  5. Step 5

    Patient feedback

    Patients are asked to complete psychological questionnaires to assess their perception of the treatment.

    The quality of the cell suspension and its relation to tissue oxygenation is also evaluated.

  6. Step 6

    Study completion

    The study is estimated to conclude by December 31, 2027.

    Final assessments will compare the effects of cell therapy with standard treatment in terms of tissue oxygenation and clinical outcomes.

Who can join the trial?

5 criteria

  • Have diabetic foot ulcers, which are sores on the foot that occur in people with diabetes, or have had a minor amputation. The ulcers should be below the ankle, and classified according to specific international standards.
  • Have chronic limb-threatening ischemia, which means there is a severe lack of blood flow to the leg, proven by medical tests. The blood flow measurement, called TcPO2, should be under 40 mm Hg.
  • Be between the ages of 18 and 90 years old.
  • Have diabetes mellitus type 1 or type 2, which are conditions where the body has trouble managing blood sugar levels.
  • Provide a signed informed consent, which means you agree to participate in the study after being informed about it.

Who cannot join the trial?

4 criteria

  • Patients who have conditions other than **diabetic foot syndrome** or **lower limb ischemia**.
  • Patients who are eligible for **PTA** (a procedure to open blocked blood vessels).
  • Patients who are not in the specified age range for the study.
  • Patients who belong to a vulnerable population.
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Investigated drugs

  • Autologous Bone Marrow-Derived Mononuclear Cell Therapy

    is a treatment that uses cells taken from the patient's own bone marrow. These cells are collected and then injected back into the patient's body to help improve blood flow and oxygenation in areas affected by poor circulation, such as in diabetic patients with chronic limb-threatening ischemia. This therapy aims to enhance healing and improve clinical outcomes for patients who are not suitable for other procedures like angioplasty.

  • Standard Treatment

    refers to the usual care provided to patients with chronic limb-threatening ischemia and diabetic foot ulcers. This can include a variety of medical and surgical interventions aimed at managing symptoms, preventing complications, and improving quality of life. The specific treatments can vary but generally focus on improving blood flow, managing diabetes, and caring for foot ulcers to prevent further damage.

What is already known about the treatment

Autologous Bone Marrow-Derived Mononuclear Cell Therapy – This treatment involves using a patient's own bone marrow cells, which are collected and then reintroduced into the body. It is currently being studied in clinical trials to assess its effectiveness compared to standard treatments for conditions like diabetic foot syndrome and lower limb ischemia. The therapy aims to improve blood flow and tissue oxygenation in patients with chronic limb-threatening ischemia who cannot undergo certain surgical procedures. At the molecular level, these cells are believed to promote healing by enhancing blood vessel formation and reducing inflammation. This therapy falls under the category of regenerative medicine, focusing on repairing and regenerating damaged tissues.

Investigated diseases

  • Diabetic Foot Syndrome

    This condition occurs in individuals with diabetes and involves the development of ulcers, infections, or sores on the feet. It is primarily caused by nerve damage and poor blood circulation, which are common complications of diabetes. As the condition progresses, the affected areas may become more prone to infections due to reduced healing ability. Without proper care, these infections can worsen, leading to more severe foot problems. The syndrome often requires careful management to prevent further complications. Regular monitoring and foot care are essential to manage this condition effectively.

  • Lower Limb Ischemia

    This condition is characterized by reduced blood flow to the legs, often due to narrowed or blocked arteries. It can cause symptoms such as pain, cramping, or weakness in the legs, especially during physical activities. As the condition progresses, it may lead to more severe symptoms, including pain at rest and non-healing wounds. The lack of adequate blood supply can result in tissue damage and increase the risk of infections. Managing this condition involves improving blood flow to the affected areas. Early detection and lifestyle changes can help slow the progression of the disease.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-519687-40-00Protocol codeBMMNC_CLI_002Estimated enrolment60 patientsSponsorInstitute For Clinical And Experimental Medicine

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