NCT07587047 · Adia Med of Winter Park LLC
Adia Med of Winter Park LLC Lower Back Pain Research Study
What this study is about
The goal of this clinical study is to evaluate the safety and preliminary effectiveness of an experimental umbilical cord blood-derived stem cell and exosome infusion in adults with chronic lower back pain associated with degenerative spine disease.
View original scientific description
The goal of this clinical study is to evaluate the safety and preliminary efficacy of an investigational umbilical cord blood-derived stem cell and exosome infusion in adults with chronic lower back pain associated with degenerative spine disease. The primary questions this study aims to answer are whether the investigational infusion is safe and well tolerated and whether treatment may reduce pain and improve physical function and quality of life. Researchers will compare the investigational infusion to a placebo (saline solution) to evaluate potential treatment effects in participants with chronic mechanical lower back pain. Participants will receive either the investigational infusion or placebo intravenously during a study visit, complete pain, disability, and quality-of-life assessments, undergo magnetic resonance imaging (MRI) and laboratory testing, and attend follow-up evaluations over a 6-month period. Participants initially assigned to placebo may later receive the investigational treatment during an open-label crossover phase of the study.
Interventions
BIOLOGICAL
Umbilical Cord Blood-Derived Stem Cells and Exosomes
Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.
OTHER
Placebo IV
Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).
Primary outcome measures
Change in Average Low Back Pain Intensity From Baseline to Month 3
Time frame: Baseline to Month 3
Measured using the Visual Analog Scale (VAS-Average), a 0-10 scale assessing average low back pain intensity over the past week, with higher scores indicating greater pain severity.
Change in Functional Disability From Baseline to Month 3
Time frame: Baseline to Month 3
Measured using the Oswestry Disability Index (ODI), a validated questionnaire assessing disability related to low back pain, scored from 0-100%, with higher scores indicating greater disability.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18-85 years
- Chronic lower back pain ≥3 months
- MRI within 12 months demonstrating one or more qualifying diagnoses: Degenerative disc disease Disc bulge or herniation Modic changes Facet joint osteoarthritis Mixed disc and facet pathology
- Baseline VAS-Average ≥4/10
- Able to comply with study visits and procedures
- Able to provide written informed consent
- Able to meet study cost requirements ($5,000 study fee plus MRI costs, if applicable) as described in the informed consent
Exclusion criteria
- Pregnancy or breastfeeding
- Prisoners or decisionally impaired adults
- Active malignancy (except non-melanoma skin cancer)
- Immunodeficiency or active systemic infection
- Prior lumbar surgery within 12 months
- Epidural steroid or facet joint injection within 3 months
- Participation in another interventional trial within 30 days
- Known allergy to product components
- Any medical condition posing unacceptable risk per investigator judgment.
- Prior stem cell therapy: History of stem cell therapy (including umbilical cord blood-derived stem cells or exosomes) at any time prior to screening
Where
- Winter Park, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations