Study on the Effectiveness of Autologous Bone Marrow-Derived Mononuclear Cells and Angioplasty in Diabetic Patients with Chronic Limb-Threatening Ischemia

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for people with chronic limb-threatening ischemia and diabetic foot ulcers. These conditions are serious complications often seen in individuals with diabetes, where there is poor blood flow to the legs and feet, leading to severe pain and ulcers that are difficult to heal. The treatment being tested involves a combination of autologous cell therapy and a procedure called percutaneous transluminal angioplasty (PTA). Autologous cell therapy uses a patient’s own cells, specifically autologous bone marrow-derived mononuclear cells, which are injected into the body to help improve blood flow and healing. This cell therapy is also known by the code names REXMYELOCEL-T or REX-001.

The purpose of the study is to compare the effectiveness of this combined treatment with the standard treatment of PTA alone. Participants in the study will receive either the combination of cell therapy and PTA or just PTA. The study will monitor the rate of major amputations, the healing of wounds, and the oxygen levels in the tissues of the affected limbs. These factors will help determine how well the treatments are working. The study will also look at other aspects such as pain levels, overall quality of life, and any side effects that may occur.

Throughout the study, participants will undergo regular check-ups and assessments to track their progress. The study aims to provide valuable information on whether the addition of autologous cell therapy can improve outcomes for patients with these challenging conditions. The trial is expected to continue for several years to gather comprehensive data on the long-term effects and safety of the treatments being tested.

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 a 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. Females of childbearing potential must use a highly effective method of contraception during the study.

2 treatment allocation

Participants are allocated to one of two treatment groups: one receiving autologous cell therapy combined with percutaneous transluminal angioplasty (PTA), and the other receiving PTA alone.

The aim is to compare the effects of the combined treatment with PTA alone, focusing on outcomes such as the rate of major amputation and wound healing.

3 cell therapy preparation

For those in the combined treatment group, autologous bone marrow-derived mononuclear cells are prepared. This involves collecting bone marrow, separating the mononuclear cells, and preparing a suspension for injection.

4 treatment administration

The prepared cell suspension is administered through intramuscular injection.

PTA is performed as a standard procedure to improve blood flow in the affected limb.

5 follow-up assessments

Regular follow-up assessments are conducted to monitor the treatment’s effectiveness and safety. This includes measuring the rate of major amputation, wound healing, and TcPO2 (a measure of oxygen pressure in tissues).

Secondary assessments may include other ischemia parameters, pain evaluation, and quality of life assessments using standardized questionnaires.

6 monitoring for side effects

Participants are monitored for any adverse events, both expected and unexpected, to ensure safety throughout the trial.

Who Can Join the Study?

Have diabetic foot ulcers (sores on the foot due to diabetes) or have had a minor amputation, following specific international classifications.
Have chronic limb-threatening ischemia, which means poor blood flow to the limbs, proven by medical tests. The TcPO2 (a test measuring oxygen in the skin) should be under 40 mm Hg, and there should be a need for PTA (a procedure to open blocked blood vessels).
Be between the ages of 18 and 90 years.
Have diabetes mellitus type 1 or 2, which are common types of diabetes.
Provide signed informed consent, meaning you agree to participate after understanding the study details.
If you are a female who can have children, you must agree to use a highly effective method of birth control during the study. This can include hormonal methods, barrier methods like condoms, or choosing not to have sex. The method should have a failure rate of less than 1% per year if used correctly.

Who Cannot Join the Study?

Patients who do not have chronic limb-threatening ischemia or diabetic foot ulcers cannot participate. These are serious conditions affecting blood flow and causing wounds on the feet.
Patients who are not within the specified age range cannot participate. The trial is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. This means the trial is looking for specific types of patients.
Both male and female patients can participate, but those who do not meet other criteria cannot join.
Patients who are considered part of a vulnerable population cannot participate. This means people who might need special protection or care are not included.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Iwjtyjilv Fjf Cvhewtjl Anh Etqrtrdfffjb Mrfutsvm	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not yet recruiting	01.07.2025

Trial locations

Investigated drugs:

AUTOLOGOUS BONE MARROW-DERIVED MONONUCLEAR CELLS

Autologous Cell Therapy is a treatment that uses cells taken from the patient’s own body. These cells are processed and then reintroduced into the patient’s body to help repair and regenerate damaged tissues. In this trial, the therapy is used to improve blood flow and promote healing in patients with chronic limb-threatening ischemia.

Percutaneous Transluminal Angioplasty (PTA) is a procedure used to open up blocked or narrowed blood vessels, usually in the legs. It involves inserting a small balloon into the blood vessel and inflating it to widen the vessel and improve blood flow. This procedure is commonly used to treat conditions that cause poor circulation, such as chronic limb-threatening ischemia in diabetic patients.

Investigated diseases:

Diabetic foot

Chronic Limb-Threatening Ischemia – This condition occurs when there is a severe reduction in blood flow to the limbs, often due to narrowed or blocked arteries. It can lead to pain, especially when walking or at rest, and may cause wounds or sores that do not heal properly. Over time, the lack of adequate blood supply can result in tissue damage and increase the risk of infections. If untreated, it may lead to significant complications in the affected limb.

Diabetic Foot Ulcers – These are open sores or wounds that commonly develop on the feet of individuals with diabetes. They occur due to a combination of factors such as poor circulation, nerve damage, and high blood sugar levels. The ulcers can be slow to heal and are prone to infection, which can complicate the healing process. Proper care and monitoring are essential to prevent further complications.

Trial ID:

2024-512873-29-00

Protocol code:

BMMNC_PTA_003

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Autologous Bone Marrow-Derived Mononuclear Cells and Angioplasty in Diabetic Patients with Chronic Limb-Threatening Ischemia

What is this study about?

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