Adia Med of Winter Park LLC Lower Back Pain Research Study (NCT07587047) | Clinical Trial Compass
RecruitingPhase 1
Adia Med of Winter Park LLC Lower Back Pain Research Study
United States100 participantsStarted 2026-06-16
Plain-language summary
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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on safety and early testing, what is currently known about the risks of the treatment being studied, and how does that uncertainty compare to my current treatment options for chronic mechanical lower back pain?
2This trial measures changes in pain intensity and functional disability over 3 months — based on my specific situation, is a 3-month commitment realistic for me, and what would I need to do or stop doing during that time?
3Because this is a Phase 1 study, the primary goal is likely to establish safety rather than prove the treatment works — does that change your recommendation about whether I should consider this versus starting a more established treatment first?
4What types of patients with chronic lower back pain are typically included or excluded from early-phase studies like this one, and do you think my particular history and condition would make me a good or poor fit to even discuss with the research team?
5If I enroll and the treatment doesn't reduce my pain or improve my ability to function by the 3-month mark, what would my options be at that point — would I still have access to standard care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Average Low Back Pain Intensity From Baseline to Month 3
Timeframe: Baseline to Month 3
2
Change in Functional Disability From Baseline to Month 3