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Study on the Effectiveness of Autologous Bone Marrow Mesenchymal Stem Cell Injection for Patients with Chronic Low Back Pain Due to Lumbar Disc Degeneration

Verified siteRegistered 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 the effects of a new treatment for people suffering from chronic low back pain due to a condition called intervertebral disc degeneration (IDD). The treatment being tested involves an injection of a special type of cell called autologous bone marrow mesenchymal stem cells (BM-MSCs) directly into the affected discs in the spine. These cells are taken from the patient's own body, which is what "autologous" means, and are believed to help repair and regenerate the damaged discs.

The purpose of the study is to evaluate how effective this treatment is in reducing pain and improving the quality of life for patients over a period of 12 months. Participants in the study will receive the BM-MSC injection and will be monitored at various intervals to assess changes in their pain levels, functionality, and overall well-being. The study will also use Magnetic Resonance Imaging (MRI) to observe any changes in the treated discs over time.

Throughout the study, the safety and tolerability of the treatment will be closely monitored by recording any adverse events that participants may experience. The study aims to provide valuable insights into whether this innovative cell therapy can offer a new option for those struggling with chronic low back pain due to IDD.

The research process

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

  1. Step 1

    Initial assessment

    The initial assessment involves a thorough evaluation to confirm eligibility for the trial. This includes verifying age between 18 and 65 years, confirming chronic low back pain due to moderate intervertebral disc degeneration, and ensuring the pain is unresponsive to conservative treatments for at least 6 months.

    An MRI is conducted to confirm the integrity of the annulus fibrosus. Pain levels are assessed using a visual analog scale (VAS), and a baseline pain level greater than 40 mm is required.

    A washout period for NSAIDs and painkillers is necessary before screening. For females of childbearing potential, a negative pregnancy test is required.

  2. Step 2

    Treatment administration

    The treatment involves an intradiscal injection of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs). This is a one-time procedure aimed at reducing chronic low back pain and improving functionality and quality of life.

    The injection is administered directly into the intervertebral disc.

  3. Step 3

    Follow-up assessments

    Follow-up assessments are scheduled at 1, 3, 6, and 12 months after the injection. These assessments include evaluating pain relief using the VAS, functionality using the Oswestry Disability Index (ODI), and quality of life using the SF-36 questionnaire.

    Quantitative MRI signal measurements are conducted to assess changes in the treated intervertebral disc.

  4. Step 4

    Safety monitoring

    Throughout the study, safety and tolerability are monitored by recording any adverse events. The severity and correlation of these events to the treatment are evaluated.

    The consumption of pain-relief medications, such as paracetamol and other analgesics, is also monitored at each visit.

  5. Step 5

    Final evaluation

    At the end of the 12-month period, a final evaluation is conducted to determine the overall effectiveness of the treatment. This includes assessing improvements in pain and functionality, as well as any changes in quality of life.

    Responders are defined as those who show at least a 30% improvement in VAS or ODI scores compared to baseline.

Who can join the trial?

9 criteria

  • Age between 18 and 65 years
  • Signed informed consent
  • Have **chronic low back pain** due to moderate **intervertebral disc degeneration** (IDD) at a maximum of 3 levels of the lower back, which has not improved with regular treatments like physiotherapy, pain relievers such as NSAIDs, paracetamol, opioids, and muscle relaxants for at least 6 months
  • The outer layer of the spinal disc, called the **annulus fibrosus**, must be intact, as shown by an **MRI** (a type of scan)
  • Have a pain level greater than 40 mm on a **Visual Analogue Scale (VAS)**, which measures pain from 0 to 100
  • Stop taking **NSAIDs** (a type of pain reliever) at least 2 days before the screening
  • Stop taking other painkillers at least 24 hours before the screening
  • For females who can become pregnant, a negative pregnancy test must be documented at the screening
  • Both men and women should use effective birth control during treatment and for at least 24 months after stopping the treatment with **BM-MSCs** (a type of cell therapy). Breastfeeding should be stopped during treatment and not restarted after stopping the treatment

Who cannot join the trial?

4 criteria

  • Patients with conditions other than low back pain cannot participate. This study is specifically for those with low back pain.
  • Patients with more than three levels of lumbar intervertebral disc degeneration (IDD) are excluded. This means if more than three discs in the lower back are affected, the patient cannot join.
  • Patients who are not within the specified age range cannot participate. The study has a specific age group it is focusing on.
  • Patients who are part of a vulnerable population are not eligible. This refers to groups that might need special protection or care.
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Investigated drugs

Autologous Mesenchymal Stem/Stromal Cells (BM-MSCs) are cells taken from the patient's own bone marrow. These cells are then processed and injected into the intervertebral discs. The goal of this therapy is to help regenerate the damaged discs and reduce chronic lower back pain. This treatment aims to improve the patient's pain levels, functionality, and overall quality of life over a period of 12 months.

What is already known about the treatment

Autologous Mesenchymal Stem Cells (BM-MSCs) – This treatment involves injecting a patient's own mesenchymal stem cells directly into the intervertebral disc. It is currently being studied in clinical trials for its potential to relieve chronic low back pain caused by lumbar disc degeneration. The main therapeutic indication is to reduce pain and improve functionality and quality of life in patients with this condition. At the molecular level, these stem cells are believed to promote tissue repair and regeneration by differentiating into various cell types and releasing growth factors. This treatment falls under the category of regenerative medicine, focusing on using the body's own cells to heal damaged tissues.

Investigated diseases

Low Back Pain – Low back pain is a common condition characterized by discomfort or pain in the lower back area. It can result from various causes, including muscle strain, ligament sprain, or issues with the spine such as intervertebral disc degeneration. The pain may be acute or chronic, lasting for weeks or even longer. It often affects mobility and can interfere with daily activities. The condition may also be associated with stiffness and reduced flexibility in the back. Over time, the pain can fluctuate in intensity and may be influenced by physical activity or prolonged periods of inactivity.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519112-14-00Protocol codeDREAM-GR-2018-12367Estimated enrolment52 patientsSponsorFondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon

sourced from the EU Clinical Trials Register and site verification

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