Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain
ConditionLow Back Pain
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age20+
SponsorR3 Stem Cell
About this trial
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
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Lumbar Injections with 10cc's of Wharton's Jelly Allograft
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
R3 Stem Cell
Lead sponsor
R3 Medical Research
Collaborator
Source ClinicalTrials.gov