Active not recruitingPHASE2, PHASE3INTERVENTIONAL

Efficacy of Intradiscal Injection of BM-MSC in Subjects With Chronic Low Back Pain (LBP) Due to Lumbar Degenerative Disc Disease (DDD) Unresponsive

This research is investigating a new treatment for chronic lower back pain that comes from worn-out spinal discs (Degenerative Disc Disease). Many people suffer from this, and current treatments aren't always effective. The study uses a special injection of stem cells, taken from a donor, directly into the affected disc. This new treatment is being compared to a 'sham procedure,' which is like a dummy treatment, to fairly assess its effects. Scientists want to see if the stem cells can help reduce pain and improve how well people can move and live their everyday lives over 12 months. This is a big step to find a better solution for this common problem.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

University Hospital, Montpellier

Enrolment target

113

Start

18 Feb 2019

Estimated completion

08 Mar 2026

Recurrent Low Back Pain Degenerative Disc Disease (DDD)

What is this study about?

This study is about exploring a new way to treat persistent lower back pain. Many people experience this kind of pain, especially when it's caused by 'Degenerative Disc Disease,' which is when the cushioning discs between your spinal bones wear down over time. It's a common issue, and for some, current treatments don't offer enough relief.

The researchers are testing a new treatment that involves injecting special 'stem cells' directly into the worn-out disc. These stem cells are taken from a donor and are thought to help repair and regenerate the disc tissue. This treatment has shown promising results in earlier, smaller studies, where patients reported less pain and improved movement without significant side effects.

To make sure the results are reliable, this study will compare the stem cell injection to a 'sham procedure.' A sham procedure is like a placebo; it looks and feels like the real treatment but doesn't contain the active stem cells. This helps scientists understand if the improvements are truly due to the stem cells or other factors. The main goal is to see if this stem cell injection can significantly reduce pain and improve a person's ability to live their life without as much discomfort for at least two years.

Key takeaways

New stem cell treatment for chronic lower back pain due to worn-out discs.
Compares stem cell injection to a dummy procedure (sham).
Aims to reduce pain and improve daily function over 12 months.
Participants will not know if they receive the real treatment or the sham.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you need to be between 18 and 60 years old and have had lower back pain for at least three months that hasn't gotten better with regular treatments like physical therapy or common painkillers. Your back pain must be due to a specific type of disc wear and tear in your spine, confirmed by scans.

You also need to meet certain health criteria. For example, your pain should be at a specific level, and you shouldn't have had certain other medical treatments recently, like steroid injections in your spine within the last three months. There are also checks to make sure your spine is stable enough for the treatment.

Some things would mean you can't join the study. These include having other spine conditions like severe curvature (scoliosis), prior spine surgery, having received specific medications recently, or having a high body mass index (BMI) over 35. They also can't include you if you're in another clinical trial or if there's a high chance you'll need back surgery in the next six months.

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 between 18 and 60 years old?
Have you had lower back pain for at least 3 months that hasn't improved with typical treatments?
Has a doctor told you your pain is due to worn-out spinal discs?
Have you avoided steroid injections in your spine for the past 3 months?
Do you have a Body Mass Index (BMI) of 35 or less?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have several checks to make sure you're suitable. Once enrolled, you will be randomly assigned to either receive the stem cell injection or a 'sham procedure.' Neither you nor your doctor will know which one you receive. The injection will be given directly into the affected disc in your lower back.

After the procedure, you'll have follow-up appointments over 12 months. During these visits, doctors will assess your pain levels using a scale and ask questions about how your back pain affects your daily activities. They will compare your results from before the treatment to how you feel 12 months later to see if there's an improvement. The total duration of active follow-up for the main part of the study is 12 months, though the detailed description mentions a longer-term goal of at least 24 months for pain and disability reduction.

Potential risks and benefits

There are potential benefits to taking part in this study, as the new stem cell treatment might reduce your pain and improve your ability to move and carry out daily activities, offering a solution where other treatments haven't worked. However, as with any medical procedure, there are potential risks, such as those related to the injection itself, like infection or bleeding, and it's not yet known if the stem cells will definitely work or if there could be unforeseen side effects. Also, because this is a new treatment, the full long-term effects aren't completely understood. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

UH Montpellier
Verified postcode
Montpellier, France
CHU de Nantes
Verified postcode
Nantes, France
CHU Saint Antoine
Verified postcode
Paris, France
APHP Cochin
Verified postcode
Paris, France
BG Klinikum Bergmannstrost
Verified postcode
Halle, Germany
Campus Bio-Medico University of Rome
Verified postcode
Roma, Italy
Institut de Teràpia Regenerativa Tissular
Verified postcode
Barcelona, Spain
Clínica Universidad de Navarra
Verified postcode
Pamplona, Spain
Hospital Sagrado Corazón Valladolid
Verified postcode
Valladolid, Spain

Common questions

What are 'stem cells' used in this study?

These are special cells from a donor that the body might use to help repair damaged tissue in your spinal discs.

What is a 'sham procedure'?

It's a dummy procedure that looks and feels like the real treatment but doesn't contain the actual stem cells. It helps researchers compare results fairly.

Will I know if I get the stem cell treatment or the sham procedure?

No, both you and your doctors will not know which treatment you receive; this is called 'double-blind'.

How long will I be involved in the study?

You'll have an initial assessment, the procedure, and then follow-up appointments over a 12-month period.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time without it affecting your standard medical care.