Adia Med of Winter Park LLC Lower Back Pain Research Study

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Chronic Mechanical Lower Back Pain, Lower Back Pain, Chronic Lower Back Pain

In brief

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.

Key facts

Study ID

NCT07587047

Run by

Adia Med of Winter Park LLC

People needed

100

Starts

2026-06-16

Expected to finish

2028-01-01

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Adia Med Of Winter Park — Winter Park, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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