Injections of Wharton's Jelly for treating low back pain
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain
PHASE1 · R3 Stem Cell · NCT06361485
This study is testing if injections made from umbilical cord tissue can help people with chronic low back pain feel better and improve their daily activities.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | R3 Stem Cell (industry) |
| Locations | 4 sites (Scottsdale, Arizona and 3 other locations) |
| Trial ID | NCT06361485 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety and feasibility of umbilical cord Wharton's Jelly allograft injections in 100 participants suffering from chronic lumbar pain. Participants will receive a series of lumbar injections and will be monitored for one year to assess safety, pain relief, and functional improvements. The study is open label and non-controlled, focusing on the effects of the treatment without a comparison group.
Who should consider this trial
Good fit: Ideal candidates are adults over 20 years old with chronic lumbar pain and a pain score of 4 or more on the Numeric Pain Rating Scale.
Not a fit: Patients who have taken pain medications or NSAIDs within two weeks prior to the injection date may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients suffering from chronic low back pain.
How similar studies have performed: While this approach is novel, similar studies exploring the use of allografts for pain management have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • 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. 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. * Have a lumbar infection or have used antibiotics for lumbar infection within the past 3 months. * Have participated in any other clinical study or treatment (not just for the lumbar spine, but for any reason) with any investigational product within the past 30 days prior to inclusion of study. * Female participants who are breast feeding or are pregnant or desire to become pregnant during the course of the study. * Contraindications to radiographic or MRI imaging. * Serious neurological, psychological or psychiatric disorders. * Injury or disability claims under current litigation or pending or approved workers compensation claims.
Where this trial is running
Scottsdale, Arizona and 3 other locations
- R3 Anti Aging Scottsdale — Scottsdale, Arizona, United States (RECRUITING)
- R3 Anti Aging Beverly Hills — Beverly Hills, California, United States (RECRUITING)
- Scheer Medical Wellness — New York, New York, United States (RECRUITING)
- Dr. Duc (Steve) Le, MD — Cleveland, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: David L Greene, MD, PhD, MBA
- Email: dgreene@r3medicalresearch.com
- Phone: (602) 677-8981
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Low Back Pain, lumbago, low back pain, lumbar spondylosis, lumbar arthritis, facet syndrome, umbilical, umbilical cord allograft