Who is eligible for clinical trial NCT06361485?

Participants must meet protocol criteria for Low Back Pain. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06361485 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2024-04-09

Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain (NCT06361485)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: R3 Stem Cell

🩺 Plain-English Summary (8th-Grade Level)

This is a Pilot Study that is an open label, prospective, non-controlled study in which the safety and feasibility of Wharton's Jelly (WJ) allograft will be evaluated in 100 participants suffering with low back pain.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (18 items).

Location: R3 Anti Aging Scottsdale — Scottsdale, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Patient must
Be over age 20.
Suffering from chronic lumbar pain
Body Mass Index (BMI) \<50 Kilograms/m2.
Pain score of 4 or more on the Numeric Pain Rating Scale (NPRS).
Female participants must be abstinent, surgically sterilized or postmenopausal.
Premenopausal females must be on contraceptive measures and do not anticipate pregnancy during the duration of the study.
Be willing and capable of giving written informed consent to participate in English.
Be willing and capable of complying with study-related requirements, procedures and visits.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Patient must not
Have taken any pain medication including nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to study injection date.
Use anticoagulants have a substance abuse history, and fail to agree not to take any lumbar symptom modifying drugs during the course of the study without discussing and reporting the use to the site Clinical investigator and study team.
Known allergy to penicillin, sulfa or amphotericin medications.
Have had any lumbar injections (at all) of any drug in lumbar spine in the past 6 months.
Have had surgery on the lumbar spine within the past 6 months.
Had a traumatic injury to the lumbar spine with the past 3 months.
Planned elective surgery during the course of the study.
A history of organ or hematologic transplantation, rheumatoid arthritis, or other autoimmune disorders.
Be on immunosuppressive medications.
Have a diagnosis of carcinoma with the past 5 years.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (4 Sites)

R3 Anti Aging Scottsdale — Scottsdale, Arizona
R3 Anti Aging Beverly Hills — Beverly Hills, California
Scheer Medical Wellness — New York, New York
Dr. Duc (Steve) Le, MD — Cleveland, Texas

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗