Adia Med of Winter Park LLC Lower Back Pain Research Study

Part of paid clinical trials in Winter Park, Florida.

Sponsor
Adia Med of Winter Park LLC
Study ID
NCT07587047
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Umbilical Cord Blood-Derived Stem Cells and Exosomes — BIOLOGICAL
    Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.
  • Placebo IV — OTHER
    Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).

Study Details

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.

Key Dates

Start date
May 15, 2026
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Stem Cell
  • Placebo Comparator: Placebo Control (with Crossover)

Primary Outcome Measure

Change in Average Low Back Pain Intensity From Baseline to Month 3 [ Time Frame: Baseline to Month 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Adia Med Of Winter ParkWinter ParkFlorida32789
Larry Powalisz
[email protected]
3217880850

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