RecruitingPhase 1NCT06361485

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

Sponsor

R3 Stem Cell

Enrollment

100 participants

Start Date

Mar 25, 2024

Study Type

INTERVENTIONAL

Conditions

Low Back Pain

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

Min Age: 20 Years

Inclusion Criteria9

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 Criteria17

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.