Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Intervertebral Disc REgeneration mediated by Autologous Mesenchymal stem/stromal cells intradiscal injection: a phase IIB randomized clinical trial

This research trial is investigating a new treatment for ongoing low back pain. Doctors will take special cells, called stem cells, from a patient's own body. These cells are then injected into the discs in the patient's spine, which are often a source of back pain. The main goal is to see if this treatment helps to reduce pain and improve how well people can move and do everyday activities after 12 months. They'll measure this by looking at changes in pain levels and a score that shows how much back pain affects daily life. The study also checks for any side effects and how the treatment might change the back discs themselves.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon

Enrolment target

Start

13 Feb 2025

low back pain

What is this study about?

This study is a clinical trial exploring a new approach to treating ongoing lower back pain. Many people suffer from back pain caused by problems with the discs between the bones in their spine. These discs can wear down or get damaged, leading to discomfort and difficulty with daily tasks.

The treatment being tested involves using a person's own unique stem cells. These are special cells that have the ability to develop into different types of cells in the body. For this study, doctors will take stem cells from the patient's own bone marrow and then carefully inject them directly into the problematic discs in their back. The idea is that these stem cells might help to repair or regenerate the damaged disc tissue.

The main aim of the study is to find out if this stem cell injection can significantly reduce back pain and improve how well people function in their daily lives. Researchers will follow participants for 12 months, checking their pain levels and how easily they can do everyday activities. They'll also monitor the treatment's safety and look for any changes in the back discs using special scans.

Key takeaways

This study is testing a new stem cell treatment for ongoing lower back pain.
It uses your own stem cells injected into your back discs.
The main goal is to see if it reduces pain and improves daily activities.
Participation lasts for 12 months with regular check-ups.
Potential risks and benefits are part of any study; you can withdraw at any time.

Who may be eligible?

This study is designed for adults aged 18 and over who are experiencing persistent lower back pain. Both men and women are welcome to participate.

More specific details about your health and medical history would be needed to know if this study is right for you. For example, certain types of severe back problems or other serious health conditions might mean you aren't able to join.

If you have long-lasting lower back pain and are interested in exploring new treatment options, you should speak to your doctor or the study team to see if you might be a good fit.

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 ongoing lower back pain?
Are you interested in a new treatment that uses your own cells?
Are you able to attend appointments for up to 12 months?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive an injection of your own stem cells into your back. Over the next 12 months, you would have several follow-up appointments. These visits would involve discussing your pain levels and daily activities, filling out questionnaires, and potentially having MRI scans to see how your back is changing. The research team will also carefully track any side effects you might experience and keep an eye on any pain relief medication you might be taking. The total duration of your participation in this study would be 12 months.

Potential risks and benefits

You might experience benefits such as reduced pain or improved daily function, but there's no guarantee the treatment will work for everyone, as it's still being investigated. As with any medical procedure, there are potential risks, such as discomfort from the injection, infection, or other side effects, which will be carefully monitored. You are free 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
Italy

Common questions

What are stem cells?

Stem cells are special cells in your body that can grow into different types of cells, helping to repair and replace damaged tissue.

Where do the stem cells come from?

In this study, the stem cells come from your own bone marrow, so they are from your own body.

How long will the study last?

If you take part, you will be in the study for a total of 12 months.

Will I know if the treatment is helping?

The study team will regularly check your pain levels and how your back pain affects your daily life to see if there are improvements.

What if I decide I don't want to continue?

You can leave the study at any time you wish, and it won't affect your regular medical care.