Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain
R3 Stem Cell
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.
Description
This is a prospective, open label, non-controlled Pilot study in which the safety and feasibility of umbilical cord Wharton's Jelly (WJ) allograft will be evaluated in participants suffering with lumbar pain. The participants will receive a series of lumbar injections described in the protocol. As this is a Pilot study primarily designed to evaluate safety, no control will be used. The dosing will consist of 10cc WJ Allograft with 100 total participants. In addition to baseline outcome instruments along with imaging and laboratory studies, participants will be followed for one year for evalua…
Eligibility
- Age range
- 20+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BiologicalLumbar Injections with 10cc's of Wharton's Jelly Allograft
Low Back Injections with Minimal Manipulation Umbilical Cord Tissue
Locations (4)
- R3 Anti Aging ScottsdaleScottsdale, Arizona
- R3 Anti Aging Beverly HillsBeverly Hills, California
- Scheer Medical WellnessNew York, New York
- Dr. Duc (Steve) Le, MDCleveland, Texas