Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain
Recruiting
Phase 1
Interventional Study
Low Back Pain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 20 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- R3 Stem Cell · Industry
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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.
Trial Locations
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Eligibility Criteria
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 …
Contacts