MedTrace Logo

Adia Med of Winter Park LLC Lower Back Pain Research Study

NCT07587047 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Chronic Mechanical Lower Back Pain
  • Lower Back Pain
  • Chronic Lower Back Pain

Interventions

BIOLOGICAL

Umbilical 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.

OTHER

Placebo IV

Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).

Sponsors & Collaborators

  • Adia Med of Winter Park LLC

    lead OTHER

Principal Investigators

  • Evan Thomas, MD, PhD · Adia Med of Winter Park LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2028-01-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07587047 on ClinicalTrials.gov