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Study on Bone Marrow Cells and Saline for Treating Severe Limb Ischemia in Patients at High Risk of Amputation

Registered drugNo 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 is focused on studying a condition known as chronic limb ischemia, which is a severe blockage in the arteries of the lower extremities that significantly reduces blood flow. This condition can lead to pain and increase the risk of amputation. The study is particularly concerned with patients who are at high risk of losing a limb due to this condition. The treatment being tested involves using autologous bone marrow-derived cells, which are cells taken from the patient's own bone marrow, to see if they can help improve blood flow and reduce the risk of amputation.

The purpose of the study is to evaluate the safety and effectiveness of this treatment. Researchers aim to see if the treatment can decrease pain, improve the function of the affected limb, and delay or prevent amputation. The study will also explore the best way to administer the treatment. Participants will receive the treatment through an injection directly into the artery, and the effects will be monitored over time to assess any changes in their condition.

Throughout the study, participants will be observed for any side effects and improvements in their condition. The goal is to determine if this new approach can offer a viable option for those who have no other surgical or medical options available. The study will help to understand if using the patient's own cells can promote healing and improve quality of life for individuals with severe chronic limb ischemia.

The research process

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

Step 1
Initial assessment
The patient undergoes an initial assessment to confirm eligibility for the trial. This includes verifying age, medical condition, and other health parameters.
Eligibility criteria include being between 18 and 90 years old, having advanced chronic ischemia with a risk of limb amputation, and no surgical or endovascular revascularization options.
Step 2
Informed consent
The patient is required to sign an informed consent form, acknowledging understanding of the trial's purpose and procedures.
Step 3
Treatment administration
The treatment involves the use of autologous bone marrow-derived cells, administered intra-arterially.
The administration aims to evaluate safety and efficacy in reducing pain, improving function, and delaying or preventing amputation.
Step 4
Monitoring and follow-up
The patient is monitored for any adverse effects and improvements in their condition.
Primary endpoints include changes in anatomical and functional measures, such as the ankle/brachial index and ischemic ulcer size.
Step 5
Trial completion
The trial is estimated to conclude by April 30, 2025.
Final assessments are conducted to evaluate the overall outcomes of the treatment.

Who can join the trial?

8 criteria

The patient must be between **18 and 90 years old**.
The patient must have **advanced chronic ischemia**, which is a condition where blood flow to the limbs is severely reduced, classified as **Fontaine III-IV** or **Rutherford IV-V**. This means the patient is at risk of losing at least one limb.
The patient must have **no option for surgical or endovascular revascularization**, meaning there are no available procedures to restore blood flow to the affected limb.
The patient must have a **life expectancy of more than 2 years**.
The patient must have **normal blood parameters**, which include:
- **Leukocytes** (a type of white blood cell) must be **3000 or more**.
- **Neutrophils** (another type of white blood cell) must be **1500 or more**.
- **Platelets** (cells that help with blood clotting) must be **140,000 or more**.
- The patient must provide **signed informed consent**, which means they agree to participate in the study after being informed about it.

Who cannot join the trial?

5 criteria

Patients with a condition called advanced chronic ischemia in the most severe stages (Fontaine III-IV class and Rutherford IV-V) are not eligible. This condition involves poor blood flow to the limbs, which can lead to a risk of losing a limb.
Patients who are at risk of having at least one limb amputated cannot participate.
Individuals who are not within the specified age range for the study are excluded. The study is open to certain age groups only.
Both men and women can participate, but those who do not meet the gender criteria are excluded.
People who are considered part of a vulnerable population, which means they might need special protection or care, are not eligible for this study.

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Investigated drugs

Autologous Bone Marrow Derived Cells: These are special cells taken from a patient's own bone marrow. They are used in this trial to treat chronic limb ischemia, a condition where blood flow to the limbs is reduced, increasing the risk of amputation. The goal is to see if these cells can help improve blood flow, reduce pain, and prevent the need for amputation.

Saline

What is already known about the treatment

Autologous Bone Marrow Derived Cells – This treatment involves the administration of cells derived from a patient's own bone marrow, typically injected directly into the affected limb. It is currently being studied in clinical trials for its potential to treat advanced chronic limb ischemia, particularly in cases where there is a high risk of amputation. The main therapeutic indication is to improve blood flow and reduce the risk of limb loss in patients with severe arterial blockages. At the molecular level, these cells are believed to promote new blood vessel formation and repair damaged tissues. This approach falls under the category of regenerative medicine, focusing on using the body's own cells to heal and restore function.

Investigated diseases

Chronic Limb Ischemia – This condition occurs when there is a severe reduction in blood flow to the limbs, often due to narrowed or blocked arteries. It typically progresses through stages, starting with pain during exercise and advancing to pain at rest. In severe cases, it can lead to tissue damage and ulcers due to the lack of oxygen and nutrients. The condition is classified into stages, such as Fontaine III-IV and Rutherford IV-V, indicating the severity of symptoms and risk of complications. Chronic limb ischemia can significantly impact mobility and quality of life, as it may lead to the risk of amputation if not managed properly.