Study of an Intravenous Umbilical Cord Blood Stem Cell and Exosome Infusion for Adults With Chronic Mechanical Lower Back Pain Randomized, Placebo-Controlled, Single-Blind Crossover Trial to Assess Safety and Preliminary Effectiveness

What this Trial Is About

This research aims to evaluate the safety and early effects of an investigational intravenous infusion made from umbilical cord blood-derived stem cells and exosomes in adults with chronic mechanical lower back pain linked to degenerative spine disease. The study is designed as a randomized, placebo-controlled, single-blind crossover trial involving about 100 participants aged 18 to 85 years. Researchers want to find out if the infusion is safe, well tolerated, and whether it can reduce pain, improve physical function, and enhance quality of life compared to a placebo. Participants receive a single intravenous infusion of either the investigational stem cell and exosome product or a saline placebo administered over about five minutes, followed by at least one hour of monitoring. After three months, those initially given placebo may receive the investigational treatment during an open-label crossover phase. The study includes screening, baseline, and follow-up visits at months 1, 3, and 6, with assessments including MRI scans and laboratory tests. The trial excludes pregnant or breastfeeding individuals, prisoners, those with recent lumbar surgery or spinal injections, active infections, malignancies, or prior stem cell therapy. During the study, participants complete pain, disability, and quality-of-life questionnaires. Researchers monitor safety through adverse event tracking and laboratory evaluations. The main outcomes measured are changes in average low back pain intensity and functional disability from baseline to three months. Secondary outcomes include any treatment-emergent adverse events over six months. The study lasts about six months per participant and includes safeguards such as pre-infusion screening and independent safety oversight. Participants pay a 5,000 study fee plus possible MRI costs, and the trial aims to provide preliminary data to guide future research rather than confirm treatment effectiveness.

Adia Med of Winter Park LLC Lower Back Pain Research Study