Adia Med of Winter Park LLC Lower Back Pain Research Study

May 13, 2026 updated by: Adia Med of Winter Park LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study evaluates the safety and preliminary efficacy of a single intravenous infusion of an investigational umbilical cord blood-derived stem cell and exosome product in adults with chronic mechanical lower back pain. It is designed as a randomized, placebo-controlled, single-blind crossover clinical trial involving approximately 100 participants between 18 and 85 years old. The research primarily aims to characterize short-term safety while also exploring potential improvements in pain, disability, quality of life, MRI findings, and inflammatory biomarkers. Participants must have chronic low back pain lasting at least three months and MRI-confirmed degenerative spinal pathology such as disc disease, disc bulges, or facet joint osteoarthritis. The study excludes pregnant individuals, prisoners, people with active infections or malignancies, and those who recently underwent lumbar surgery or spinal injections. Participants are recruited through clinic databases, physician referrals, advertisements, and outreach to people previously interested in regenerative therapies. Researchers emphasize that the intervention is investigational, not FDA approved for lower back pain, and not guaranteed to provide improvement. Participants are randomized to receive either the investigational infusion or placebo saline administered intravenously over approximately five minutes with at least one hour of monitoring afterward. Those initially assigned to placebo may later receive the investigational product during an open-label crossover at three months. Outcome measures include Visual Analog Scale pain scores, Oswestry Disability Index assessments, SF-36 quality-of-life surveys, MRI reviews, and inflammatory biomarker testing. Study visits occur during screening, baseline, and follow-up evaluations at months 1, 3, and 6. Potential risks include infusion reactions, allergic responses, infection, thrombotic complications, and unknown long-term biologic effects. The protocol includes safety safeguards such as pre-infusion screening, emergency response equipment, structured adverse-event monitoring, and oversight by an independent Data Safety Monitoring Board. Researchers state that direct benefits are uncertain, although some participants may experience reduced pain or improved function and quality of life. Participants are required to pay a $5,000 study fee plus possible MRI costs, and the protocol acknowledges that this may bias enrollment toward individuals with higher socioeconomic status. The study is exploratory in nature and intended to generate feasibility, safety, and effect-size data to guide future larger clinical trials rather than establish definitive efficacy.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Adia Med Of Winter Park
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stem Cell
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.
Placebo Comparator: Placebo Control (with Crossover)
Other: Placebo IV
Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Average Low Back Pain Intensity From Baseline to Month 3
Time Frame: 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
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Baseline through Month 6
Assessment of safety and tolerability based on the frequency, severity, and relationship of adverse events following investigational infusion, graded using Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Baseline through Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adia Med of Winter Park LLC

Investigators

  • Principal Investigator: Evan Thomas, MD, PhD, Adia Med of Winter Park LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

May 8, 2026

First Submitted That Met QC Criteria

May 8, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adia Med LBP Research Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lower Back Pain

Clinical Trials on Umbilical Cord Blood-Derived Stem Cells and Exosomes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe