NCT07587047 Adia Med of Winter Park LLC Lower Back Pain Research Study
| NCT ID | NCT07587047 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Adia Med of Winter Park LLC |
| Condition | Chronic Mechanical Lower Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-06-16 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2026-06-16 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Evan Thomas, MD, PhD
PRINCIPAL INVESTIGATOR
Adia Med of Winter Park LLC
Frequently Asked Questions
Who can join the NCT07587047 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Chronic Mechanical Lower Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07587047 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07587047 currently recruiting?
Yes, NCT07587047 is actively recruiting participants. Contact the research team at research@adiamed.com for enrollment information.
Where is the NCT07587047 trial being conducted?
This trial is being conducted at Winter Park, United States.
Who is sponsoring the NCT07587047 clinical trial?
NCT07587047 is sponsored by Adia Med of Winter Park LLC. The principal investigator is Evan Thomas, MD, PhD at Adia Med of Winter Park LLC. The trial plans to enroll 100 participants.