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Tests treatment safety and results for Low Back Pain
Official title Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain
ClinicalTrials.gov ID: NCT06361485
What this study is testing
What is Lumbar Injections with 10cc's of Wharton's Jelly Allograft?
Lumbar Injections with 10cc's of Wharton's Jelly Allograft is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for low back pain.
Also referred to as BelloWJY.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- 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).
You likely can't join if
- 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...
- 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.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Beverly Hills, California, United States
- New York, New York, United States
- Cleveland, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Beverly Hills, California, United States; New York, New York, United States; Cleveland, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.