Adia Med of Winter Park LLC Lower Back Pain Research Study

NCT07587047 | Recruiting Phase 1 FDA Drug

• 1 other identifier: Adia Med LBP Research Study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Lower Back Pain; Chronic Mechanical Lower Back Pain; Chronic Lower Back Pain

Keywords

stem cell; stem cell therapy; chronic lower back pain

Outcome Measures

Primary Outcomes (2)

• Change in Average Low Back Pain Intensity From Baseline to Month 3

  Measured using the Visual Analog Scale (VAS-Average), a 0-10 scale assessing average low back pain intensity over the past week, with higher scores indicating greater pain severity.

  Baseline to Month 3

• Change in Functional Disability From Baseline to Month 3

  Measured using the Oswestry Disability Index (ODI), a validated questionnaire assessing disability related to low back pain, scored from 0-100%, with higher scores indicating greater disability.

  Baseline to Month 3

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  Baseline through Month 6

Study Arms (2)

Stem Cell

EXPERIMENTAL

Biological: Umbilical Cord Blood-Derived Stem Cells and Exosomes

Placebo Control (with Crossover)

PLACEBO COMPARATOR

Other: Placebo IV

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.

Stem Cell

Placebo IV OTHER

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

Placebo Control (with Crossover)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or breastfeeding
• Prisoners or decisionally impaired adults
• Active malignancy (except non-melanoma skin cancer)
• Immunodeficiency or active systemic infection
• Prior lumbar surgery within 12 months
• Epidural steroid or facet joint injection within 3 months
• Participation in another interventional trial within 30 days
• Known allergy to product components
• Any medical condition posing unacceptable risk per investigator judgment.

Sponsors & Collaborators

• Adia Med of Winter Park LLC: lead

Study Sites (1)

Adia Med Of Winter Park

Winter Park, Florida, 32789, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Evan Thomas, MD, PhD

  Adia Med of Winter Park LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larry Powalisz

CONTACT

3212312843; ceo@adiamed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)