R3 Stem Cell
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.
Low Back Pain
Lumbar Injections with 10cc's of Wharton's Jelly Allograft
PHASE1
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 evaluation of safety, pain relief and functional improvements.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 100 participants |
Masking : | NONE |
Masking Description : | Open Label |
Primary Purpose : | TREATMENT |
Official Title : | Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain |
Actual Study Start Date : | 2024-03-25 |
Estimated Primary Completion Date : | 2027-03-31 |
Estimated Study Completion Date : | 2028-04-01 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 20 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
R3 Anti Aging Scottsdale
Scottsdale, arizona, United States, 85262
RECRUITING
R3 Anti Aging Beverly Hills
Beverly Hills, California, United States, 90210
RECRUITING
Scheer Medical Wellness
New York, New York, United States, 10036
RECRUITING
Dr. Duc (Steve) Le, MD
Cleveland, Texas, United States, 77327