NCT06361485 Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain
| NCT ID | NCT06361485 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | R3 Stem Cell |
| Condition | Low Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-03-25 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2024-03-25 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
James Faber, BA
STUDY CHAIR
Institute of Cellular and Regenerative Medicine IRB
Frequently Asked Questions
Who can join the NCT06361485 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06361485 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06361485 currently recruiting?
Yes, NCT06361485 is actively recruiting participants. Contact the research team at dgreene@r3medicalresearch.com for enrollment information.
Where is the NCT06361485 trial being conducted?
This trial is being conducted at Scottsdale, United States, Beverly Hills, United States, New York, United States, Cleveland, United States.
Who is sponsoring the NCT06361485 clinical trial?
NCT06361485 is sponsored by R3 Stem Cell. The principal investigator is James Faber, BA at Institute of Cellular and Regenerative Medicine IRB. The trial plans to enroll 100 participants.