Recruiting
Phase 1

Umbilical Cord Blood

Sponsor:

Adia Med of Winter Park LLC

Code:

NCT07587047

Conditions

Chronic Mechanical Lower Back Pain

Lower Back Pain

Chronic Lower Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Umbilical Cord Blood-Derived Stem Cells and Exosomes

Placebo IV

Study Details

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.

Conditions

Chronic Mechanical Lower Back Pain

Lower Back Pain

Chronic Lower Back Pain

Study ID

NCT07587047

Start date

Jun 16, 2026

Status verified date

Jun, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stem Cell

placebo comparator: Placebo Control (with Crossover)

Interventions

Umbilical Cord Blood-Derived Stem Cells and Exosomes

Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.

Placebo IV

Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).

Primary outcome measure

  • Change in Average Low Back Pain Intensity From Baseline to Month 3 [ Time Frame: Baseline to Month 3 ]
  • Change in Functional Disability From Baseline to Month 3 [ Time Frame: Baseline to Month 3 ]

Central Contacts and Locations

Central contacts

Locations

Adia Med Of Winter Park

Recruiting

Winter Park, Florida, United States, 32789

Contacts

More Information

Sponsor

Adia Med of Winter Park LLC

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • stem cell
  • stem cell therapy
  • chronic lower back pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Adia Med of Winter Park LLC on 2026-06-17.