Ongoing Clinical Trials for Intervertebral Disc Degeneration
There are currently 2 clinical trials investigating new treatments for intervertebral disc degeneration, a condition where the cushions between spine bones break down and cause chronic back pain. These trials are testing innovative stem cell therapies that aim to regenerate damaged discs and reduce pain in patients who haven’t found relief from standard treatments. The trials are taking place in Germany and Denmark.
Clinical trial locations
- Denmark
- Germany
Study on MSV/AS for Chronic Low Back Pain in Patients with Degenerative Disc Disease Unresponsive to Conventional Therapy
This clinical trial is being conducted in Germany and focuses on testing a novel cell therapy approach for people suffering from chronic low back pain caused by degenerative disc disease.
Main inclusion criteria:
- Age between 18 and 60 years
- Chronic low back pain that has not improved with standard treatments for at least 3 months
- Confirmed degenerative disc disease with specific grading scores
- Pain levels greater than 40 mm on a 100 mm visual scale
- Willingness to stop pain relief medications before screening
Main exclusion criteria:
- Other significant back conditions beyond degenerative disc disease
- Previous back surgery
- Severe allergies to medications or treatments used in the study
- Certain chronic illnesses that could affect study results
- Pregnancy or breastfeeding
- Current participation in another clinical trial
- History of substance abuse
- Inability to commit to the study schedule and follow-up visits
Focus and goal: The trial aims to determine whether allogeneic bone marrow stromal mesenchymal cells can effectively reduce chronic low back pain and improve spinal disc health. Participants will receive either the cell therapy or a placebo through an injection directly into the affected spine disc. The study will last approximately 12 months, with regular check-ups to monitor pain levels using visual pain scales and the Oswestry Disability Index. MRI scans will be used to assess changes in disc fluid content and structure. Researchers will also track quality of life improvements and changes in pain medication use.
Investigational drug: The treatment being tested uses allogeneic BM-MSCs, which are stem cells derived from a donor’s bone marrow. These cells are injected into the spine discs with the goal of promoting tissue repair, reducing inflammation, and potentially increasing disc fluid content to improve cushioning between vertebrae.
Study on Degenerative Disc Disease: Effects of Autologous Adipose-Derived Mesenchymal Stem Cells in Patients with Degenerative Disc Disease
This clinical trial is taking place in Denmark and explores a different type of stem cell therapy using cells from a patient’s own body fat.
Main inclusion criteria:
- Age between 20 and 60 years
- Lumbar back pain affecting a maximum of 2 levels of the spine
- Moderate disc degeneration classified as Pfirman grade 2-3
Main exclusion criteria:
- Absence of degenerative disc disease
- Age outside the specified range
- Being part of a vulnerable population
Focus and goal: This study investigates whether autologous adipose-derived mesenchymal stem cells can regenerate damaged spinal discs and improve symptoms. The treatment involves harvesting stem cells from a patient’s own fat tissue, expanding them in a laboratory, and then injecting them directly into the affected disc. The trial includes a control group for comparison and will monitor participants for two years. Researchers will use pain diaries and multiple health questionnaires including VAS-score, EQ-5D, ODI, SF-36, and LBPRS to assess pain reduction, quality of life, and physical function. MRI scans will track structural changes in the discs, including height, water content, and the presence of various substances that indicate disc health.
Investigational drug: The therapy uses AD-MSC, autologous adipose-derived mesenchymal stem cells harvested from the patient’s own body fat. This personalized approach aims to help repair damaged spinal tissues by injecting the patient’s processed stem cells into the degenerated disc area, potentially reducing pain and improving spinal function.
Summary
Both trials represent promising advances in regenerative medicine approaches to treating degenerative disc disease. A notable difference between the two studies is the source of stem cells: the German trial uses donor-derived cells, while the Danish trial uses cells from the patient’s own body. Both studies share similar age requirements and focus on patients with confirmed disc degeneration causing chronic pain. The trials employ comprehensive monitoring methods including pain scales, quality of life questionnaires, and advanced imaging to evaluate treatment effectiveness. The expected completion of the Danish study by the end of 2026 will provide valuable long-term data on stem cell therapy outcomes. These trials offer hope for patients who have not found relief through conventional treatments.
