Study on MSV/AS for Chronic Low Back Pain in Patients with Degenerative Disc Disease Unresponsive to Conventional Therapy

4 1 1

What is this study about?

This clinical trial is focused on studying a condition known as Degenerative Disc Disease, which often causes chronic low back pain. The trial is testing a new treatment using a special type of cell therapy called MSV Allogenic bone marrow stromal mesenchymal cells. These cells are injected into the spine to see if they can help reduce pain and improve the condition of the discs in the spine.

The purpose of the study is to find out if this cell therapy can effectively reduce chronic low back pain and improve the health of the spinal discs in people who have not found relief from other treatments. Participants in the study will receive either the cell therapy or a placebo. The study will last for about 12 months, during which participants will have regular check-ups to monitor their pain levels and the condition of their spinal discs using imaging techniques like Magnetic Resonance Imaging (MRI).

Throughout the study, participants’ overall health, quality of life, and any changes in their use of pain medication will be closely observed. The trial aims to provide valuable information on whether this new treatment can offer a better option for those suffering from chronic low back pain due to Degenerative Disc Disease.

1 Initial Screening

Eligibility is determined based on age (18-60 years) and chronic low back pain that has not improved with standard treatments for at least three months.

Pain levels are assessed using a visual analog scale (VAS) where a score greater than 40 mm is required.

A washout period for non-steroidal anti-inflammatory drugs (NSAIDs) and painkillers is necessary before screening.

2 Baseline Assessment

Baseline measurements include pain levels using the VAS and functional status using the Oswestry Disability Index (ODI).

Magnetic Resonance Imaging (MRI) is performed to assess disc fluid content and structure.

3 Randomization and Treatment

Participants are randomly assigned to receive either the treatment or a sham procedure.

The treatment involves an intradiscal injection of allogeneic bone marrow stromal mesenchymal cells (BM-MSCs).

The injection is administered as a suspension for injection directly into the affected disc.

4 Follow-up Assessments

Follow-up visits occur at regular intervals to monitor pain levels, functional status, and any changes in disc fluid content.

Pain relief is considered significant if there is at least a 20% improvement in VAS scores or ODI scores after 12 months.

5 Final Evaluation

At 12 months, a comprehensive evaluation is conducted to assess the efficacy of the treatment.

MRI is used to measure changes in disc fluid content and structure.

Secondary outcomes include quality of life assessments and any changes in medication use.

Who Can Join the Study?

Age between 18 and 60 years at the pre-screening visit
Experiencing chronic low back pain that does not get better with usual treatments, including pain medication, for at least 3 months
Degenerative Disc Disease (DDD) confirmed by a specific grading system, with a score between 4 and 7 at one level. If there is a second level affected, it should be next to the first one, with a score between 1 and 4
Low back pain measured at more than 40 mm on a scale from 0 to 100 during screening
No use of NSAIDs (a type of pain relief medication) for at least 2 days before screening
No use of painkillers for at least 24 hours before screening

Who Cannot Join the Study?

Patients with any other significant back condition besides Degenerative Disc Disease cannot participate. This means if you have another major back problem, you may not be eligible.
Individuals who have had previous back surgery may be excluded. This refers to any surgical procedure done on your back in the past.
People with severe allergies, especially to medications or treatments used in the study, might not be able to join. Severe allergies are strong reactions your body has to certain substances.
Patients with certain chronic illnesses that could interfere with the study results may be excluded. Chronic illnesses are long-lasting health conditions.
Women who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Individuals who are currently participating in another clinical trial may not be eligible. This means if you are already part of another study, you might not be able to join this one.
People with a history of substance abuse, which means misuse of drugs or alcohol, might be excluded.
Patients who cannot commit to the study schedule or follow-up visits may not be able to participate. This means if you cannot attend all required appointments, you might not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
BG Klinikum Bergmannstrost Halle gGmbH	Halle (Saale)	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	18.02.2019

Trial locations

Investigated drugs:

Msv/As

Allogeneic BM-MSCs: This therapy involves the use of stem cells derived from the bone marrow of a donor. These cells are injected into the discs of the spine to help reduce chronic low back pain caused by lumbar degenerative disc disease. The goal is to see if these stem cells can improve pain levels and increase the fluid content in the discs, potentially leading to better function and less discomfort for patients.

Investigated diseases:

Intervertebral disc degeneration

Degenerative Disc Disease – This condition involves the gradual deterioration of the discs between the vertebrae in the spine. As the discs wear down, they lose their ability to cushion the vertebrae, which can lead to pain and reduced mobility. The disease often begins with minor discomfort and can progress to more severe pain, particularly in the lower back. Over time, the affected discs may become thinner, leading to increased pressure on the spine and surrounding nerves. This can result in symptoms such as numbness, tingling, or weakness in the limbs. The progression of the disease varies among individuals, with some experiencing significant symptoms while others may have minimal discomfort.

Trial ID:

2023-510000-45-00

Protocol code:

9766_RECHMPL17_0206

NCT ID:

NCT03737461

Trial Phase:

Therapeutic use (Phase IV)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on MSV/AS for Chronic Low Back Pain in Patients with Degenerative Disc Disease Unresponsive to Conventional Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?