Adia Med of Winter Park LLC Lower Back Pain Research Study
RecruitingPhase 1NCT07587047
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- 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
- Conditions
- Chronic Mechanical Lower Back Pain
- Lower Back Pain
- Chronic Lower Back Pain
- Interventions
- Biological: Umbilical Cord Blood-Derived Stem Cells and Exosomes
- Other: Placebo IV
- Sponsor
- Adia Med of Winter Park LLC
- Start date
- 2026-06-16
- Primary completion
- 2028-01
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07587047