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Msv/As

This article explores a clinical trial investigating the use of MSV/AS, a type of mesenchymal stem cell therapy, for treating chronic low back pain caused by degenerative disc disease (DDD). The study aims to assess the effectiveness and safety of intradiscal injections of allogeneic bone marrow mesenchymal stem cells in patients who have not responded to conventional treatments.

Table of Contents

What is MSV/AS?

MSV/AS is an investigational medical treatment that uses allogeneic adult bone marrow mesenchymal stem cells (BM-MSCs). These are special cells taken from the bone marrow of healthy donors, which have the potential to help repair and regenerate tissues[1]. The treatment is currently being studied as a potential therapy for chronic low back pain caused by degenerative disc disease.

What Condition Does MSV/AS Target?

MSV/AS is being developed to treat chronic low back pain due to lumbar degenerative disc disease (DDD) that hasn’t responded to conventional therapies[1]. DDD is a condition where the discs between the vertebrae in your spine break down over time, leading to pain and reduced mobility. This condition can significantly impact a person’s quality of life and ability to perform daily activities.

How Does MSV/AS Work?

The treatment involves injecting MSV/AS directly into the affected disc in the spine. The stem cells are believed to help:

  • Reduce inflammation in the disc
  • Promote tissue repair and regeneration
  • Increase the fluid content of the disc, which may improve its function
By addressing these factors, MSV/AS aims to reduce pain and improve the overall function of the affected disc[1].

Current Clinical Trial

MSV/AS is currently being studied in a Phase 2/3 clinical trial. This trial is:

  • Prospective: it follows patients forward in time
  • Multicentre: conducted at multiple medical centers
  • Randomized: patients are randomly assigned to receive either MSV/AS or a sham treatment
  • Double-blind: neither the patients nor the researchers know who is receiving the actual treatment
The trial aims to assess both the effectiveness and safety of MSV/AS in treating chronic low back pain due to DDD[1].

Who Can Participate in the Trial?

The trial has specific criteria for who can participate. Some key eligibility factors include:

  • Age between 18 and 60 years
  • Chronic low back pain for at least 3 months that hasn’t responded to conservative treatments
  • Confirmed degenerative disc disease on MRI
  • Pain level greater than 40 mm on a 100 mm visual analog scale (VAS)
There are also several exclusion criteria, such as certain medical conditions or previous spine surgeries, that might prevent participation[1].

What Does the Treatment Process Involve?

The treatment involves a single injection of MSV/AS directly into the affected disc. Specifically:

  • 20 million mesenchymal stem cells (plus or minus 10%) are injected
  • The cells are suspended in 2 ml of fluid
  • The injection is done under local anesthesia
Patients in the control group receive a sham procedure to maintain the study’s blinding[1].

Potential Benefits of MSV/AS

The researchers are looking at several potential benefits of MSV/AS, including:

  • Reduction in back pain
  • Improvement in physical function and disability
  • Better quality of life
  • Increased fluid content in the affected disc (which may indicate improved disc health)
  • Reduced need for pain medications
These outcomes are being measured at various time points up to 24 months after treatment[1].

Safety Considerations

As with any medical treatment, safety is a crucial consideration. The trial is closely monitoring for any side effects or complications. Some specific safety aspects being evaluated include:

  • Any adverse events related to the injection procedure
  • Potential immune reactions to the donor cells
  • Effects on the overall immune system
  • Long-term safety up to 5 years after treatment (in Germany)
It’s important to note that as an experimental treatment, all potential risks may not be known at this time[1].

Aspect Details
Study Type Phase 2/3 prospective, multicentre randomized, double-blind trial
Intervention Intradiscal injection of allogeneic bone marrow mesenchymal stem cells (MSV/AS)
Control Group Sham-treated controls
Primary Objectives 1. Assess pain reduction and functional improvement 2. Evaluate increase in disc fluid content
Key Measurements Visual Analog Scale (VAS), Oswestry Disability Index (ODI), MRI scans
Duration 24 months (60 months in Germany)
Eligibility Adults 18-60 years with chronic low back pain due to DDD, unresponsive to conventional therapy
Safety Monitoring Adverse events, immune response, systemic immune system effects

FAQ

  • What is MSV/AS and how is it used in this clinical trial? MSV/AS is a type of mesenchymal stem cell therapy derived from bone marrow. In this trial, it is injected directly into the affected spinal disc to potentially reduce pain and improve disc health in patients with degenerative disc disease.
  • Who is eligible to participate in this clinical trial? Eligible participants are adults aged 18-60 with chronic low back pain due to degenerative disc disease that hasn't responded to conservative therapy for at least 3 months. They must have a specific level of disc degeneration and pain intensity.
  • What are the main objectives of this clinical trial? The main objectives are to assess if MSV/AS can reduce chronic low back pain, improve functional status, and increase disc fluid content after 12 months of treatment. The study also aims to evaluate long-term safety and efficacy up to 24 months.
  • How is the effectiveness of MSV/AS measured in this trial? Effectiveness is measured using pain scales (VAS), functional status (ODI), quality of life assessments (SF-36), and MRI scans to evaluate changes in disc fluid content and overall disc health.
  • What are the potential benefits and risks of participating in this trial? Potential benefits include reduced pain and improved disc health. Risks may include procedure-related complications such as infections, bleeding, or nerve irritation. The trial also monitors for any immune responses to the allogeneic cell injection.

Ongoing Clinical Trials on Msv/As

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

    Recruiting

    1 1 1
    Investigated drugs:
    Germany

Glossary

  • Degenerative Disc Disease (DDD): A condition where the spinal discs break down or deteriorate, often causing pain and reduced mobility.
  • Mesenchymal Stem Cells (MSCs): A type of adult stem cell that can develop into various cell types, including bone, cartilage, and fat cells.
  • Allogeneic: Cells or tissues that are taken from a donor rather than the patient themselves.
  • Intradiscal injection: A procedure where medication is injected directly into a spinal disc.
  • Visual Analog Scale (VAS): A measurement tool used to assess pain intensity on a scale from 0 to 100.
  • Oswestry Disability Index (ODI): A questionnaire used to measure the degree of disability and quality of life in a person with low back pain.
  • Magnetic Resonance Imaging (MRI): A medical imaging technique that uses magnetic fields and radio waves to create detailed images of the body's internal structures.
  • Sham procedure: A fake or placebo treatment that mimics the real treatment but has no therapeutic effect, used for comparison in clinical trials.
  • Pfirrmann's score: A grading system used to assess the degree of lumbar disc degeneration on MRI scans.

References

  1. http://clinicaltrials.eu/trial/study-on-msv-as-for-chronic-low-back-pain-in-patients-with-degenerative-disc-disease-unresponsive-to-conventional-therapy/