A Phase 1 investigational study evaluating a single intravenous stem cell infusion for adults with chronic mechanical lower back pain associated with degenerative spine disease.
This Phase 1 investigational study evaluates the safety and preliminary efficacy of a single intravenous infusion of AdiaVita - a regenerative therapy made from umbilical cord blood-derived stem cells and exosomes - in adults with chronic mechanical lower back pain associated with degenerative spine disease. This 6-month, randomized, placebo-controlled, single-blind crossover study aims to determine whether the treatment reduces pain and improves physical function and quality of life.
Conducted under structured medical supervision, the study follows defined research protocols to evaluate safety, tolerability, and preliminary observations related to regenerative medicine interventions. All participants undergo comprehensive clinical evaluations including MRI and laboratory testing before, during, and after the study period. The study is approximately 100 adults aged 18 to 85 may participate.
Initial evaluation, medical history review, MRI review, and assessment of eligibility criteria including baseline pain assessment using the Visual Analog Scale (VAS).
Comprehensive baseline assessments including pain scores (VAS), disability assessment (Oswestry Disability Index), quality-of-life surveys (SF-36), MRI, and laboratory testing to establish starting measurements.
Participants receive a single intravenous infusion of either AdiaVita (umbilical cord blood-derived stem cells and exosomes) or a placebo saline solution, administered over approximately 5 minutes with at least one hour of monitoring afterward.
Pain, disability, and quality-of-life assessments at Month 1 and Month 3. At Month 3, participants initially assigned to placebo may receive the investigational AdiaVita treatment during an open-label crossover phase if eligible.
Final evaluation including pain scores, disability assessment, quality-of-life surveys, MRI review, and safety monitoring. The total study duration per participant is 6 months.
The one-time participation fee includes all investigational procedures, physician oversight, the stem cell therapy infusion, and crossover treatment if applicable. Travel to Orlando is excluded from this cost.
The participation cost may be financed through CareCredit. This flexible payment option allows participants to manage the financial aspects of participation. Qualified applicants may be eligible for 0% interest financing for up to 2 years.
If you have a sponsor for the study, please contact our clinical coordination team for information regarding 501(c)(3) nonprofit organization details and sponsorship verification processes.
This is a Phase 1, randomized, placebo-controlled, single-blind crossover trial with two treatment arms. Participants are randomly assigned to receive either the investigational AdiaVita infusion (umbilical cord blood-derived stem cells and exosomes) or a placebo saline infusion. The study is single-blind, meaning participants will not know which treatment they receive. Approximately 100 adults aged 18 to 85 with chronic mechanical lower back pain will participate.
Participants receive a single IV infusion at the baseline visit, followed by follow-up evaluations at months 1, 3, and 6. At Month 3, participants initially assigned to placebo may receive the investigational AdiaVita treatment during an open-label crossover phase if eligible.
While this is an investigational study and direct benefits are uncertain, participants may potentially benefit from:
Complete the form below to express interest and learn more about the study.
Complete a comprehensive screening including medical history review, MRI review, and baseline pain assessment.
Our team will review your information and confirm eligibility based on study criteria.
Meet with clinical staff to review the study protocol and sign informed consent documentation.
Begin baseline evaluations and proceed with the investigational treatment infusion.
Study Information
This is a Phase 1 research study testing whether a single intravenous infusion of AdiaVita - a regenerative treatment made from umbilical cord blood-derived stem cells and exosomes - is safe and can help reduce pain and improve physical function and quality of life in adults with chronic mechanical lower back pain associated with degenerative spine disease.
Adults ages 18 to 85 years old who have chronic lower back pain lasting at least 3 months, with MRI-confirmed degenerative spinal pathology (such as degenerative disc disease, disc bulge or herniation, Modic changes, or facet joint osteoarthritis) and a baseline pain score of 4 or higher on a 0-10 scale. The study plans to include approximately 100 participants. A doctor will check if you qualify during screening.
The study lasts 6 months for each participant. You will receive a single IV infusion at the baseline visit, followed by follow-up evaluations at months 1, 3, and 6 for pain assessments, disability and quality-of-life surveys, MRI review, and safety monitoring.
It's a randomized, single-blind study, meaning participants are randomly placed into one of two groups and do not know which treatment they receive:
Group 1: Receives a single intravenous infusion of AdiaVita stem cells and exosomes.
Group 2: Receives a placebo (saline solution) infusion.
A placebo looks like the real treatment but contains no active ingredients. At Month 3, participants initially assigned to the placebo group may receive the investigational AdiaVita treatment during an open-label crossover phase if they meet eligibility criteria.
At the Adia Med clinic in Winter Park, Florida.
This is a Phase 1, FDA-regulated investigational study. Safety is closely monitored by the research team and an independent Data Safety Monitoring Board throughout the study. The infusion is administered over approximately 5 minutes with at least one hour of monitoring afterward. All participants undergo regular assessments, MRI review, laboratory testing, and adverse event monitoring. Risks may include infusion reactions, allergic responses, infection, thrombotic complications, and unknown long-term biologic effects. The study team tracks and reports any serious problems.
TAKE THE NEXT STEP
Consultations are confidential and conducted by our Orlando-based
clinical staff - for local and international patients alike.
