Adia Med of Winter Park LLC Lower Back Pain Research Study

Официальное название

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

Обзор

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.

Подробное описание

The study evaluates the safety and preliminary efficacy of a single intravenous infusion of an investigational umbilical cord blood-derived stem cell and exosome product in adults with chronic mechanical lower back pain. It is designed as a randomized, placebo-controlled, single-blind crossover clinical trial involving approximately 100 participants between 18 and 85 years old. The research primarily aims to characterize short-term safety while also exploring potential improvements in pain, disability, quality of life, MRI findings, and inflammatory biomarkers. Participants must have chronic low back pain lasting at least three months and MRI-confirmed degenerative spinal pathology such as disc disease, disc bulges, or facet joint osteoarthritis. The study excludes pregnant individuals, prisoners, people with active infections or malignancies, and those who recently underwent lumbar surgery or spinal injections. Participants are recruited through clinic databases, physician referrals, advertisements, and outreach to people previously interested in regenerative therapies. Researchers emphasize that the intervention is investigational, not FDA approved for lower back pain, and not guaranteed to provide improvement. Participants are randomized to receive either the investigational infusion or placebo saline administered intravenously over approximately five minutes with at least one hour of monitoring afterward. Those initially assigned to placebo may later receive the investigational product during an open-label crossover at three months. Outcome measures include Visual Analog Scale pain scores, Oswestry Disability Index assessments, SF-36 quality-of-life surveys, MRI reviews, and inflammatory biomarker testing. Study visits occur during screening, baseline, and follow-up evaluations at months 1, 3, and 6. Potential risks include infusion reactions, allergic responses, infection, thrombotic complications, and unknown long-term biologic effects. The protocol includes safety safeguards such as pre-infusion screening, emergency response equipment, structured adverse-event monitoring, and oversight by an independent Data Safety Monitoring Board. Researchers state that direct benefits are uncertain, although some participants may experience reduced pain or improved function and quality of life. Participants are required to pay a $5,000 study fee plus possible MRI costs, and the protocol acknowledges that this may bias enrollment toward individuals with higher socioeconomic status. The study is exploratory in nature and intended to generate feasibility, safety, and effect-size data to guide future larger clinical trials rather than establish definitive efficacy.

Вмешательства

• Биопрепарат 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.
• Другое Placebo IV
  Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).

Первичные конечные точки

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

Вторичные конечные точки (1)

• Incidence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Baseline through Month 6]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Adia Med Of Winter Park — Winter Park

Идентификаторы

NCT: NCT07587047 · Adia Med LBP Research Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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