Actively Recruiting
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain
Led by R3 Stem Cell · Updated on 2024-04-11
100
Participants Needed
4
Research Sites
209 weeks
Total Duration
On this page
Sponsors
R
R3 Stem Cell
Lead Sponsor
R
R3 Medical Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be over age 20.
- Have chronic lumbar pain.
- Have a Body Mass Index (BMI) under 50 kilograms per square meter.
- Have a pain score of 4 or more on the Numeric Pain Rating Scale.
- Female participants must be abstinent, surgically sterilized, postmenopausal, or using contraceptive measures and not anticipate pregnancy during the study.
- Be willing and able to give written informed consent in English.
- Be willing and able to comply with study procedures and visits.
You will not qualify if you...
- Have taken any pain medication including NSAIDs within 2 weeks before the injection.
- Use anticoagulants, have substance abuse history, or take lumbar symptom-modifying drugs without reporting to the study team.
- Have known allergies to penicillin, sulfa, or amphotericin medications.
- Have had any lumbar injections in the past 6 months.
- Have had lumbar spine surgery in the past 6 months.
- Have had a traumatic lumbar spine injury in the past 3 months.
- Have planned elective surgery during the study.
- Have history of organ or blood transfusion, rheumatoid arthritis, or autoimmune disorders.
- Be on immunosuppressive medications.
- Have a cancer diagnosis within the past 5 years.
- Have lumbar infection or used antibiotics for lumbar infection within the past 3 months.
- Have participated in another clinical study or treatment with investigational products within 30 days before enrollment.
- Female participants who are breastfeeding, pregnant, or planning pregnancy during the study.
- Have contraindications to radiographic or MRI imaging.
- Have serious neurological, psychological, or psychiatric disorders.
- Have injury or disability claims involved in current litigation or workers compensation claims.
AI-Screening
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Trial Site Locations
Total: 4 locations
1
R3 Anti Aging Scottsdale
Scottsdale, Arizona, United States, 85262
Actively Recruiting
2
R3 Anti Aging Beverly Hills
Beverly Hills, California, United States, 90210
Actively Recruiting
3
Scheer Medical Wellness
New York, New York, United States, 10036
Actively Recruiting
4
Dr. Duc (Steve) Le, MD
Cleveland, Texas, United States, 77327
Actively Recruiting
Research Team
D
David L Greene, MD, PhD, MBA
CONTACT
K
Katherine Minter-Dykhouse, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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