A phase 2/3 prospective, multicentre randomized, double-blind trial, comparing intra-discal allogeneic adult BM-MSC therapy and sham-treated controls in subjects with chronic low back pain due to lumbar degenerative disc disease (DDD) unresponsive to conventional therapy
Lower back pain is often caused by degenerative disc disease, where the soft cushions between the spine bones dry out and wear down over time. Standard treatments like painkillers and physiotherapy do not always provide enough relief. This clinical trial is testing an experimental therapy that uses stem cells taken from healthy adult bone marrow donors. Doctors inject these cells directly into the worn spinal disc. The aim is to see if the cells can help restore moisture, improve disc health, and ease chronic pain. Half of the participants receive the stem cell injection, while the other half receive a dummy procedure (a sham) to ensure fair comparisons. The trial lasts for two years. Doctors will measure pain levels, daily mobility, and disc healing using specialised MRI scans to find out if this treatment is a safe, effective option.
At a glance
What is this study about?
Between each bone in your spine sits a rubbery cushion called a spinal disc. These discs act like shock absorbers, helping your back bend, twist, and absorb impact. As we age, or after an injury, these discs can lose water, shrink, and wear down—a condition called degenerative disc disease. This can lead to ongoing, severe lower back pain and make simple daily tasks very difficult. When normal treatments like exercises, physical therapy, and painkillers fail to help, treatment options become quite limited.
This clinical trial is investigating whether a type of cell therapy can help heal these damaged discs from the inside. The treatment uses 'mesenchymal stem cells' collected from the bone marrow of healthy adult donors. These cells are known to calm inflammation and support tissue repair. During the study, doctors inject the cells straight into the affected disc in the lower back, hoping to restore fluid and cushion the spine.
To prove whether the treatment truly works, this is a randomised, double-blind trial. This means half of the participants receive the real stem cell injection, and half receive a 'sham' (a dummy procedure that looks and feels similar but contains no cells). Neither the patients nor the study doctors will know who received which treatment until the trial is complete. By comparing the two groups over two years, researchers can see if the stem cells offer real, lasting pain relief and better quality of life.
Key takeaways
- Tests whether donor bone marrow stem cells can repair worn spinal discs in the lower back.
- Aims to reduce chronic back pain and improve everyday physical movement.
- Compares the active stem cell injection against a dummy (sham) procedure.
- Follows your progress closely over two years using questionnaires and MRI scans.
- Aimed at adults whose back pain has not responded well to usual care.
Who may be eligible?
This study is designed for adults aged 18 and older who suffer from long-term lower back pain caused by worn-down lumbar discs (degenerative disc disease). To qualify, your back pain must be ongoing and must not have improved enough after trying standard medical treatments, such as pain medicines or physical therapy.
You will need to have a medical assessment, including MRI scans, to confirm that your pain is coming from specific worn discs in your lower spine.
You might not be able to take part if you have other specific spinal problems (such as severe nerve compression requiring urgent surgery), certain other major medical conditions, or if you are unable to safely have an MRI scan.
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 aged 18 or older?
- Do you suffer from long-term lower back pain?
- Has a doctor told you that your pain is caused by worn discs (degenerative disc disease)?
- Have standard treatments like painkillers or physio failed to provide enough relief?
- Are you able to undergo MRI scans and attend regular hospital visits for two years?
What does participation involve?
If you take part, your participation will last for about two years. The study begins with screening visits where the medical team checks your back health, reviews your medical history, and performs an MRI scan. If eligible, you will have a minor procedure where the study injection (either the donor stem cells or the dummy treatment) is given into your spinal disc under local anaesthetic.
After the injection, you will attend regular check-up visits over the next 24 months. During these visits, doctors will monitor your recovery, ask you to fill in questionnaires about your pain and daily mobility, and track any painkillers you take. You will also have follow-up MRI scans at 12 and 24 months so researchers can look closely at any changes in the disc's fluid content and structure.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What are donor stem cells?
These are special cells taken from the bone marrow of healthy adult volunteers. They are carefully screened, cleaned, and grown in a laboratory to help reduce inflammation and encourage healing.
What is a sham procedure?
A sham is a harmless dummy procedure that mimics the real treatment. It allows researchers to see whether improvements come from the stem cells themselves or from the natural placebo effect of having a procedure.
Will I know if I received the real cells or the dummy?
No. To keep the results unbiased, neither you nor the study team will know which group you are in until the entire study has finished.
Will I have to stop taking my painkillers?
You will usually be allowed to take approved 'rescue' pain medicines if you need them, but the team will ask you to record everything you take so they can measure changes in your pain relief.
Does taking part cost me anything?
No, the study treatment, clinic visits, and MRI scans are provided free of charge as part of the trial, and travel expenses are often reimbursed.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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