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Adia Med of Winter Park LLC Lower Back Pain Research Study
A Randomized, Placebo-Controlled, Single-Blind, Crossover Study to Evaluate the Safety and Preliminary Efficacy of a Single Intravenous AdiaVita (Umbilical Cord Blood - Stem Cells and Exosomes) Infusion in Adults With Chronic Mechanical Lower Back Pain
Who can join
Ages 18 to 85 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Umbilical Cord Blood-Derived Stem Cells and Exosomes (biological)
- Placebo IV (other)
Sponsor: Adia Med of Winter Park LLC · Participants: 100 · Started: Jun 16, 2026
Contact the study team
- Larry Powalisz · Phone: 3217880850
Official record on ClinicalTrials.gov — NCT07587047
Locations in the U.S.
| Florida | Adia Med Of Winter Park, Winter Park |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.