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
Adia Med of Winter Park LLC
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.
Description
The study evaluates the safety and preliminary efficacy of a single intravenous infusion of an investigational umbilical cord blood-derived stem cell and exosome product in adults with chronic mechanical lower back pain. It is designed as a randomized, placebo-controlled, single-blind crossover clinical trial involving approximately 100 participants between 18 and 85 years old. The research primarily aims to characterize short-term safety while also exploring potential improvements in pain, disability, quality of life, MRI findings, and inflammatory biomarkers. Participants must have chronic l…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
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 imp…
Interventions
- BiologicalUmbilical 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.
- OtherPlacebo IV
Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).
Location
- Adia Med Of Winter ParkWinter Park, Florida