Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain
Recruiting
Phase 1Interventional Study
Low Back Pain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
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
Who this trial is looking for
This trial is looking for adults over 20 with chronic low back pain. Participants will receive injections of Wharton's Jelly to see if it helps relieve their pain.
Are You a Good Fit for This Trial?
Must not be takingNSAIDs
Rules you outOrgan transplantationRheumatoid arthritisAutoimmune disorders
You may be able to join if
I am over age 20.
I have chronic low back pain.
My BMI is less than 50.
I have a pain score of 4 or higher.
I can provide written consent in English.
I can follow study requirements and attend visits.
If female, I am abstinent, sterilized, or postmenopausal.
You may not be able to join if
I have taken pain medications in the past 2 weeks.
I have had any lumbar injections in the past 6 months.
I have had lumbar spine surgery in the past 6 months.
I have had a traumatic injury to my lumbar spine in the past 3 months.
I am breastfeeding, pregnant, or planning to get pregnant during the study.
I have a history of serious autoimmune disorders.
I have a diagnosis of cancer in the past 5 years.
I have a lumbar infection or used antibiotics for it in the past 3 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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 Criteria:
• Patient must not
* Have taken any pain medication including nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to study injection date.
* Use anticoagulants have a substance abuse history, and fail to agree not to take any lumbar symptom modifying drugs during the course of the study without discussing and reporting the use to the site Clinical investigator and study team.
* Known allergy to penicillin, sulfa or amphotericin medications.
* Have had any lumbar injections (at all) of any drug in lumbar spine in the past 6 months.
* Have had surgery on the lumbar spine within the past 6 months.
* Had a traumatic injury to the lumbar spine with the past 3 months.
* Planned elective surgery during the course of the study.
* A history of organ or hematologic transplantation, rheumatoid arthritis, or other autoimmune disorders.
* Be on immunosuppressive medications.
* Have a diagnosis of carcinoma with the past 5 years.
* Have a lumbar infection or have used antibiotics for lumbar infection within the past 3 months.
* Have participated in any other clinical study or treatment (not just for the lumbar spine, but for any reason) with any investigational product within the past 30 days prior to inclusion of study.
* Female participants who are breast feeding or are pregnant or desire to become pregnant during the course of the study.
* Contraindications to radiographic or MRI imaging.
* Serious neurological, psychological or psychiatric disorders.
* Injury or disability claims under current litigation or pending or approved workers compensation claims.
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