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 range20 Years
SexALL
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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…
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