Stem Cells for Lower Back Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment using stem cells from umbilical cord blood to help individuals with persistent lower back pain caused by degenerative spine issues. Researchers aim to determine the treatment's safety and its potential to reduce pain and improve daily life. Participants will receive either the treatment or a saline solution (placebo) and will be monitored for changes in pain and function. Individuals with chronic lower back pain for at least three months and specific spine issues shown on an MRI may be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have had an epidural steroid or facet joint injection within the last 3 months, you would not be eligible to participate.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that using exosomes (tiny particles that help cells communicate) and stem cells from umbilical cord blood is generally safe for treating low back pain. Studies indicate that patients tolerate these treatments well, experiencing only minor side effects like swelling and pain, which typically resolve within a few weeks. These studies have reported no major problems, offering encouragement for those considering participation in a clinical trial.12345
Why do researchers think this study treatment might be promising for lower back pain?
Most treatments for lower back pain, like pain relievers or physical therapy, focus on managing symptoms rather than addressing the root cause. Researchers are excited about using umbilical cord blood-derived stem cells and exosomes because they target healing at a cellular level. These stem cells have the potential to repair and regenerate damaged tissues, which could offer longer-lasting relief and possibly even reverse the damage. Additionally, exosomes can enhance cell communication and promote tissue repair, making the treatment potentially more effective and comprehensive compared to traditional options.
What evidence suggests that this treatment might be an effective treatment for lower back pain?
Research has shown that stem cells from umbilical cord blood might help treat back pain. In this trial, participants may receive these stem cells, which clinical trials have found can greatly reduce pain and improve movement in people with long-term back problems. Studies also suggest they might help repair damaged spinal discs, which can cause pain. Importantly, past trials have used these treatments safely, indicating they are generally well-tolerated. Overall, the evidence suggests they could improve the quality of life for those with spine issues.26789
Who Is on the Research Team?
Evan Thomas, MD, PhD
Principal Investigator
Adia Med of Winter Park LLC
Are You a Good Fit for This Trial?
This trial is for adults aged 18-85 who have had chronic lower back pain for at least 3 months due to degenerative spine issues. Participants must be able to attend study visits, complete assessments, and cover a $5,000 fee plus MRI costs if needed.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants undergo baseline assessments including pain, disability, and quality-of-life evaluations, MRI, and laboratory testing
Treatment
Participants receive a single intravenous infusion of either the investigational product or placebo, followed by at least one hour of monitoring
Follow-up
Participants attend follow-up evaluations at months 1, 3, and 6 to assess safety, pain, disability, quality of life, and MRI findings
Open-label Crossover
Participants initially assigned to placebo may receive the investigational product during an open-label crossover phase at three months
What Are the Treatments Tested in This Trial?
Interventions
- Umbilical Cord Blood-Derived Stem Cells and Exosomes
Trial Overview
The study compares an IV infusion of stem cells and exosomes from umbilical cord blood with a placebo (saline) in people with chronic lower back pain. Some participants may later receive the real treatment after starting on placebo. The main focus is safety and early signs of effectiveness.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Adia Med of Winter Park LLC
Lead Sponsor
Citations
1.
cryo-cell.com
cryo-cell.com/stem-cell-insider/august-2020/uc-mscs-are-explored-for-treatment-of-spine-conditionsUC-MSCs Are Explored For Treatment of Spine Conditions
The trial shows that 4–8 microliters (μl) of umbilical cord blood mononuclear cells could be safely injected into the spinal cord above and below the injury ...
Allogeneic umbilical cord blood mononuclear cell therapy ...
A significantly higher proportion of subjects in the hUCMNCs therapy group showed improved function in pain and temperature sensation, lower limb muscle ...
Umbilical cord mesenchymal stem cells for regenerative ...
Mesenchymal stem cells have been proposed for regenerative treatment of intervertebral discs in recent years, and encouraging results have been achieved in ...
Stem Cell Therapy for Back Pain: Benefits & Administration ...
Clinical trials investigating cord tissue-derived mesenchymal stem cells for back pain treatment have shown promising results, significantly improving pain ...
5.
genesispub.org
genesispub.org/regenerative-medicine-in-spine-care-clinical-potential-of-mesenchymal-stem-cells-for-chronic-low-back-painRegenerative Medicine in Spine Care: Clinical Potential of ...
Preclinical and early-phase clinical studies have demonstrated that MSC therapy can reduce pain, improve disc hydration, and enhance functional ...
Exosomes for the Management of Low Back Pain - PMC - NIH
The results showed that administering extracellular vesicles or exosomes is safe and potentially effective in patients suffering from low back pain.
Therapeutic Effect of Exosomes Derived From Stem Cells ...
A systematic review of the role of stem cell-derived exosomes in repairing spinal cord injury (SCI) and the existing problems in animal experiments.
8.
americordblood.com
americordblood.com/articles/clinical-trials-on-stem-cells-for-orthopedic-healing?srsltid=AfmBOoqB2v7HYHdj6XWQEBs3ghRUvq8pggDQ8UQHPyrgR18s9gxUJO1yClinical Trials on Stem Cells for Orthopedic Healing
Safety: Minimal risks, with side effects like swelling and pain resolving in weeks. No major complications have been reported. Sources and Methods: Bone marrow, ...
9.
michiganih.com
michiganih.com/stem-cell-therapy-and-umbilical-cord-tissue-for-back-pain-what-to-know-before-you-decide/Stem Cell Therapy and Umbilical Cord Tissue for Back Pain
Exosomes and microvesicles, which carry signals that influence healing and reduce inflammation. These substances have the ability to repair damaged tissues.
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