protocolSection identificationModule nctId: NCT06361485, orgStudyIdInfo id: 011624, briefTitle: Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2028-04-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: R3 Stem Cell, class: INDUSTRY, collaborators name: R3 Medical Research, descriptionModule briefSummary: 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., conditionsModule conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, open label, non-controlled Pilot study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Open Label, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Lumbar Injections with 10cc's of Wharton's Jelly Allograft, outcomesModule primaryOutcomes measure: C-reactive protein, primaryOutcomes measure: Erythrocyte sedimentation rate, primaryOutcomes measure: Alanine transaminase (ALT), primaryOutcomes measure: Aspartate transaminase (AST), primaryOutcomes measure: Alkaline phosphatase (ALP), primaryOutcomes measure: Albumin, primaryOutcomes measure: Creatinine, primaryOutcomes measure: Blood Urea Nitrogen (BUN), secondaryOutcomes measure: 36-Item Short Form Survey (SF-36), secondaryOutcomes measure: Numerical Pain Rating Scale (NPRS), secondaryOutcomes measure: Oswestry disability index (ODI), secondaryOutcomes measure: Roland Morris disability questionnaire (RMQ), secondaryOutcomes measure: The Patient-specific functional scale (PSFS), eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: R3 Anti Aging Scottsdale, status: RECRUITING, city: Scottsdale, state: Arizona, zip: 85262, country: United States, contacts name: David Greene, MD, PhD, MBA, role: CONTACT, phone: 480-306-6256, email: dgreene@r3medicalresearch.com, contacts name: Sabrina Solt, NMD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.50921, lon: -111.89903, locations facility: R3 Anti Aging Beverly Hills, status: RECRUITING, city: Beverly Hills, state: California, zip: 90210, country: United States, contacts name: Kathleen Francesca, BA, role: CONTACT, phone: 424-382-1074, email: kfrancesca@r3stemcell.com, contacts name: Neville Campbell, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.07362, lon: -118.40036, locations facility: Scheer Medical Wellness, status: RECRUITING, city: New York, state: New York, zip: 10036, country: United States, contacts name: Alexandre Scheer, MD, role: CONTACT, phone: 646-762-9499, email: ascheer911@gmail.com, contacts name: Alexandre Scheer, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Dr. Duc (Steve) Le, MD, status: RECRUITING, city: Cleveland, state: Texas, zip: 77327, country: United States, contacts name: Steve Le, MD, role: CONTACT, phone: 281-593-1500, email: ducstevele@gmail.com, contacts name: Steve Le, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.67682, lon: -99.25367, hasResults: False