AuthorisedTherapeutic exploratory (Phase II)Interventional

Autologous Bone Marrow derived cells for the treatment of chronic arterial Limb Ischemia in patients with high risk of amputation

This research trial is investigating a new way to treat severe leg circulation problems, known as chronic arterial limb ischemia, where there's a high risk of losing a leg. The study uses a special treatment made from a patient's own bone marrow cells. These cells are thought to help grow new blood vessels and repair damaged ones, improving blood flow to the affected limb. Researchers want to see if this treatment can reduce pain, help leg ulcers heal, improve how far people can walk, and ultimately lower the chance of needing an amputation. Patients taking part will be compared to those receiving a dummy treatment (saline) to understand the real effects of the bone marrow cell therapy. It's a phase 2 trial, which means it's an early stage but important step in understanding this potential new treatment.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias

Enrolment target

Start

04 Feb 2025

advanced chronic ischemia (fontaine III-IV class and Rutherford IV-V)with risk of amputation of at least one limb

What is this study about?

Imagine your leg isn't getting enough blood, similar to how a plant might wilt without water. When this happens very seriously and for a long time, it's called chronic arterial limb ischemia. This can cause severe pain, especially when walking, and can lead to wounds that don't heal, sometimes even putting a leg at risk of needing to be removed (amputated).

This study is looking into a new way to help people with this severe condition. Researchers are using a person's own bone marrow – the spongy tissue inside some bones that makes blood cells. They collect some of these cells and then give them back to the patient, aiming to help improve the blood flow in the affected leg. The idea is that these special cells might encourage the body to grow new blood vessels or help repair existing ones.

The main goal is to see if this treatment can make a real difference. They'll be checking if it helps to improve how well blood flows to the leg, measure if painful sores or ulcers get smaller, and see if people can walk further without pain. Ultimately, they want to know if this treatment can help reduce the possibility of amputation. It's an important step in finding better ways to treat this challenging condition.

Key takeaways

The study explores using your own bone marrow cells to treat severe leg circulation problems.
It aims to improve blood flow, heal wounds, and reduce the risk of amputation.
Participation involves bone marrow collection and careful monitoring.
Some patients will receive the active treatment, others a dummy treatment.
You must have severe leg pain, wounds, or a high amputation risk to be eligible.
This is a research study; benefits are not guaranteed, and there are potential risks.

Who may be eligible?

This study is for adults, aged 18 and over. There's no upper age limit, meaning older adults can also take part. Both men and women are welcome to participate in this study.

To be considered for this study, you must have severe, long-lasting leg circulation problems. This means you experience significant pain in your leg or foot, even when resting, and you might have leg wounds or sores caused by poor blood flow that aren't healing well. These are considered very serious symptoms that put your leg at high risk of amputation.

You would not be able to join this study if your leg circulation problems are not as severe as described. The specific types of severity are rated by doctors using special scales (Fontaine III-IV and Rutherford IV-V), which essentially mean your condition is quite advanced and considered high-risk.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have severe, long-lasting leg pain, even at rest?
Do you have leg wounds or sores that are not healing due to poor blood flow?
Has a doctor told you that your leg is at a high risk of amputation?
Are you able to attend regular check-ups and follow-up appointments?
Are you generally willing to participate in a research study where you might receive a dummy treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have several tests to confirm your eligibility and get a baseline picture of your health and leg condition. The main treatment involves collecting a small amount of bone marrow from your body, usually from your hip bone, in a procedure similar to a bone marrow biopsy. These cells are then prepared and given back to you.

Some participants will receive the active cell treatment, while others will receive a dummy treatment (saline, which is just saltwater). This is decided by chance, like flipping a coin, and neither you nor your doctors will know which treatment you are getting. This is important for understanding if the cell treatment really works better than no specific treatment. You will have regular check-ups, assessments, and tests over a period of time to see how you are responding to the treatment. These may include measurements of blood flow in your leg, checks on any wounds, and tests of how far you can walk. The total duration of your involvement in the study will be explained to you by the study team.

Potential risks and benefits

Participating in any clinical trial has potential benefits and risks. A possible benefit of this study is that the experimental treatment might improve blood flow to your leg, reduce pain, help heal wounds, and potentially decrease your chance of needing an amputation, but this is not guaranteed. However, there are also risks, such as discomfort or side effects from the bone marrow collection procedure or the injection of the cells, and potential unknown side effects from the experimental cell therapy. You will be fully informed of all known potential risks before you decide to take part. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is chronic arterial limb ischemia?

It's a severe condition where your leg or arm isn't getting enough blood due to blocked or narrowed arteries, causing pain and potentially leading to serious wounds or even amputation.

What are 'bone marrow cells'?

These are special cells found in the spongy centre of your bones. They have the potential to repair and create new blood vessels, which is why they are being studied for this condition.

Will I know if I get the real treatment or the dummy treatment?

No, this is a 'blinded' study, meaning neither you nor your doctors will know whether you receive the active cell treatment or the saline (dummy) treatment. This helps ensure unbiased results.

What is 'amputation risk'?

It means your leg is in such a severe state due to poor blood flow that there's a significant chance it might need to be surgically removed to prevent serious complications.

Is this a new treatment?

Yes, this therapy using your own bone marrow cells is still being explored in research studies, like this Phase II trial, to determine if it is safe and effective.