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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

Status: Recruiting
Location: See location...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Adia Med Of Winter Park
RECRUITING
Winter Park
Contact Information
Primary
Larry Powalisz
research@adiamed.com
3217880850
Time Frame
Start Date: 2026-06-16
Estimated Completion Date: 2028-01
Participants
Target number of participants: 100
Treatments
Experimental: Stem Cell
Placebo_comparator: Placebo Control (with Crossover)
Related Therapeutic Areas
Sponsors
Leads: Adia Med of Winter Park LLC

This content was sourced from clinicaltrials.gov