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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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Universita’ Campus Bio-medico Di Roma Rome Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
02.11.2020

Trial locations

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.

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 ID:
2024-519112-14-00
Protocol code:
DREAM-GR-2018-12367
NCT ID:
NCT05066334
Trial Phase:
Therapeutic exploratory (Phase II)

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