Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain (NCT06361485) | Clinical Trial Compass
RecruitingPhase 1
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain
United States100 participantsStarted 2024-03-25
Plain-language summary
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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
C-reactive protein
Timeframe: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
2
Erythrocyte sedimentation rate
Timeframe: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
3
Alanine transaminase (ALT)
Timeframe: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
4
Aspartate transaminase (AST)
Timeframe: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
5
Alkaline phosphatase (ALP)
Timeframe: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
6
Albumin
Timeframe: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
7
Creatinine
Timeframe: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year