A Randomized, Placebo-Controlled, Single-Blind, Crossover Study to Evaluate the Safety and Preliminary Efficacy of a Single Intravenous AdiaVita Infusion in Adults With Chronic Mechanical Lower Back Pain

What this Trial Is About

Researchers are evaluating the safety and early effects of an investigational infusion made from umbilical cord blood-derived stem cells and exosomes in adults who have chronic mechanical lower back pain linked to degenerative spine conditions. This phase 1 clinical trial aims to determine if the infusion is safe and well tolerated, and whether it may reduce pain, improve physical function, and enhance quality of life. The study involves comparing this investigational treatment with a placebo to assess its potential benefits. Participants will receive one intravenous infusion of either the investigational stem cell and exosome product or a saline placebo during a study visit. The infusion is administered over about five minutes, followed by at least one hour of monitoring. After three months, those initially given the placebo may crossover to receive the investigational treatment. The study includes screening, baseline, and follow-up visits at 1, 3, and 6 months to assess outcomes and safety. During the study, participants will complete assessments measuring pain levels, disability, and quality of life, including Visual Analog Scale and Oswestry Disability Index scores, as well as MRI scans and lab tests for inflammatory markers. Safety is closely monitored through pre-infusion screening, structured adverse event tracking, and oversight by an independent board. The total participation time spans six months, with attention to any treatment-related effects and monitoring for potential risks such as infusion reactions or infections.

Adia Med of Winter Park LLC Lower Back Pain Research Study