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New treatment option for Chronic Mechanical Lower Back Pain
Official title Adia Med of Winter Park LLC Lower Back Pain Research Study
ClinicalTrials.gov ID: NCT07587047
What this study is testing
What is Umbilical Cord Blood-Derived Stem Cells and Exosomes?
Umbilical Cord Blood-Derived Stem Cells and Exosomes is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic mechanical lower back pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- Baseline VAS-Average ≥4/10
- Able to comply with study visits and procedures
You likely can't join if
- 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
See the full eligibility 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
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Winter Park, Florida, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winter Park, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.