In short
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.
At a glance
- 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
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. 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. 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.
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.
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.
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.
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.
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.