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Umbilical Cord Blood-Derived Stem Cells for Chronic Lower Back Pain

This study is looking for adults aged 18-85 with chronic lower back pain (pain lasting at least 3 months) due to degenerative spine conditions like disc disease or facet joint arthritis. Researchers are testing an investigational treatment called Umbilical Cord Blood-Derived Stem Cells and Exosomes, given as an intravenous (IV) infusion. This treatment contains stem cells and other beneficial components from umbilical cord blood. The study aims to see if this infusion is safe, well-tolerated, and if it can reduce your pain and improve your physical function and quality of life. You would receive either the investigational infusion or a placebo (a saline solution that looks the same but has no active ingredients). The study is currently recruiting about 100 participants.

Study design
This is a randomized, placebo-controlled, single-blind crossover clinical trial involving approximately 100 participants. This means you would be randomly assigned to receive either the active treatment or a placebo, and you wouldn't know which one you received.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures changes in pain and functional disability from when you start until 3 months later.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07587047

Adia Med of Winter Park LLC Lower Back Pain Research Study

Recruiting
PHASE1Ages 18–85InterventionalTreatment
Adia Med of Winter Park LLC
~100 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Umbilical Cord Blood-Derived Stem Cells and ExosomesPlacebo IV

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Average Low Back Pain Intensity From Baseline to Month 3
Measured over Baseline to Month 3
+1 more outcome measured

Conditions

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

Explore related trials

Intervertebral Disc Degenerative DisorderLower Back Pain

Where it's being run

1 sites across 1 states
Florida1

Study leadership

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

Who to contact

Larry Powalisz
[email protected]
3217880850
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18-85 years
Chronic lower back pain ≥3 months
MRI within 12 months demonstrating one or more qualifying diagnoses:
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

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.
Prior stem cell therapy: History of stem cell therapy (including umbilical cord blood-derived stem cells or exosomes) at any time prior to screening

What this trial measures

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

  • Change in Functional Disability From Baseline to Month 3Baseline 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.