Lower back pain: stem cell and exosome infusion vs placebo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, single-blind, crossover trial evaluating the safety and potential efficacy of an intravenous infusion of investigational umbilical cord blood–derived stem cells and exosomes in adults with chronic mechanical lower back pain due to degenerative spine disease. About 100 participants aged 18–85 will receive either the stem cell infusion or placebo saline and then crossover to the other treatment after an initial period, with monitoring over six months. Primary focus is short-term safety, with exploratory endpoints including pain, disability, quality of life, MRI findings, and inflammatory biomarkers. Participants undergo MRI, laboratory tests, and regular follow-up visits to assess responses and any adverse events. The intervention is investigational and not FDA approved for this condition, and all participants will be followed for safety and efficacy signals during the study.

Why it matters

Who can join: the full rules

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

Where it's running

• Adia Med Of Winter Park
  Winter Park, Florida, United States Recruiting

Study contacts

• Principal investigator: Evan Thomas, MD, PhD — Adia Med of Winter Park LLC
• Study coordinator: Larry Powalisz
• Email: research@adiamed.com
• Phone: 3217880850

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.