Stem Cell Injection for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for people with chronic low back pain due to facet joint osteoarthritis. It compares the safety and effectiveness of adipose-derived (fat-based) stem cell injections with standard corticosteroid injections. Participants who have experienced back pain for at least six months and have not found relief from other treatments might be suitable candidates. The goal is to determine if stem cell injections can offer better pain relief or improve joint function compared to the usual treatment. As an unphased trial, this study provides a unique opportunity to investigate innovative treatments that could potentially offer new options for pain relief.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like systemic corticosteroids and anticoagulants may need to be adjusted or stopped before participating. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that injections using stem cells from fat tissue are generally well-tolerated by people with osteoarthritis. One study examined their use for a type of back arthritis and found no major safety issues, suggesting the treatment is relatively safe for similar conditions.
These fat-derived stem cells have also been used successfully in other arthritis treatments. They can help renew and repair tissues, making them a promising option.
Corticosteroid injections are another common treatment to manage pain and swelling. When administered by a doctor, they are safe, though some people might experience temporary soreness at the injection site.
Overall, past research has demonstrated good safety for both treatments, making them viable options for those considering participation in a clinical trial.12345Why are researchers excited about this trial's treatments?
Unlike standard treatments for osteoarthritis, which often involve pain relief through medications like NSAIDs or corticosteroids, adipose-derived stem cell injections offer a regenerative approach. This treatment is unique because it uses stem cells harvested from a patient's own fat tissue, aiming to repair and regenerate damaged joint tissues. Researchers are excited about this method as it targets the root cause of joint degeneration rather than just alleviating symptoms, potentially leading to longer-lasting relief and improved joint function. Additionally, the minimally invasive procedure might reduce downtime and side effects compared to more traditional surgical interventions.
What evidence suggests that this trial's treatments could be effective for osteoarthritis?
Research shows that stem cells taken from fat tissue, known as adipose-derived stem cells (ADSCs), may help treat osteoarthritis. These cells can reduce pain and improve joint function by aiding tissue repair. Studies have found that ADSCs effectively treat knee osteoarthritis, suggesting they might also help with back pain caused by osteoarthritis. Although more research is needed specifically for back pain, current evidence for joint conditions is promising. In this trial, one group of participants will receive adipose-derived stem cell injections, while another group will receive corticosteroid injections. Corticosteroids are commonly used to reduce inflammation and relieve pain but do not support long-term healing like stem cells might. These findings suggest that adipose-derived stem cells could offer a more lasting solution for pain related to osteoarthritis.13456
Who Is on the Research Team?
Thomas Boetel, MD
Principal Investigator
Sanford Health
Are You a Good Fit for This Trial?
Adults aged 18-75 with chronic lower back pain due to facet joint osteoarthritis, who have not improved after 3 months of conservative care and physical therapy. Participants must have a baseline pain score of at least 4 out of 10 and show significant pain relief after a diagnostic injection. Exclusions include active cancer, high risk for bleeding or infection, severe autoimmune diseases, recent drug abuse, pregnancy or nursing women, extreme obesity (BMI >40), and certain medication use.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants in the treatment group undergo a small liposuction procedure and receive an ultrasound-guided injection of adipose-derived stem cells into the facet joint. The control group receives a corticosteroid injection.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of adverse events, function, and pain scores.
What Are the Treatments Tested in This Trial?
Interventions
- Adipose-derived stem cell injection
- Corticosteroid injection
Adipose-derived stem cell injection is already approved in United States, European Union, Canada for the following indications:
- Osteoarthritis of the facet joint
- Chronic lumbar back pain
- Orthopedic conditions such as osteoarthritis, joint arthritis, degenerative vertebral disks
- Orthopedic conditions such as osteoarthritis, joint arthritis, degenerative vertebral disks
Find a Clinic Near You
Who Is Running the Clinical Trial?
InGeneron, Inc.
Lead Sponsor
Sanford Health
Collaborator