Clinical trial NCT06361485: Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain
Official title: Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Low Back Pain
Keywords: lumbago
low back pain
lumbar spondylosis
lumbar arthritis
facet syndrome
umbilical
umbilical cord allograft
stem cell
exosome
Lead sponsor: R3 Stem Cell
Sponsor class: INDUSTRY
Collaborators: name: R3 Medical Research
First posted: 2024-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, open label, non-controlled Pilot study
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a prospective, open label, non-controlled Pilot study in which the safety and feasibility of umbilical cord Wharton's Jelly (WJ) allograft will be evaluated in participants suffering with lumbar pain. The participants will receive a series of lumbar injections described in the protocol.

As this is a Pilot study primarily designed to evaluate safety, no control will be used. The dosing will consist of 10cc WJ Allograft with 100 total participants. In addition to baseline outcome instruments along with imaging and laboratory studies, participants will be followed for one year for evaluation of safety, pain relief and functional improvements.

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 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.

Primary outcomes:
measure: C-reactive protein
timeFrame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
measure: Erythrocyte sedimentation rate
timeFrame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
measure: Alanine transaminase (ALT)
timeFrame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
measure: Aspartate transaminase (AST)
timeFrame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
measure: Alkaline phosphatase (ALP)
timeFrame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
measure: Albumin
timeFrame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
measure: Creatinine
timeFrame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
measure: Blood Urea Nitrogen (BUN)
timeFrame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Secondary outcomes:
measure: 36-Item Short Form Survey (SF-36)
timeFrame: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
measure: Oswestry disability index (ODI)
timeFrame: Baseline, 1 week, 6 weeks, 3 months, 6 months, 1 year
measure: Roland Morris disability questionnaire (RMQ)
timeFrame: Baseline, 1 week, 6 weeks, 3 months, 6 months, 1 year
measure: The Patient-specific functional scale (PSFS)
timeFrame: Baseline, 1 week, 6 weeks, 3 months, 6 months, 1 year
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: R3 Anti Aging Scottsdale
state: Arizona
city: Beverly Hills
country: United States
facility: R3 Anti Aging Beverly Hills
state: California
city: New York
country: United States
facility: Scheer Medical Wellness
state: New York
city: Cleveland
country: United States
facility: Dr. Duc (Steve) Le, MD
state: Texas
Study officials:
affiliation: Institute of Cellular and Regenerative Medicine IRB
name: James Faber, BA
role: STUDY_CHAIR
References:
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citation: Evaluation of the Efficacy of Cryopreserved Human Umbilical Cord Tissue Allografts to Augment Functional and Pain Outcome Measures in Patients with Knee Osteoarthritis: An Observational Data Collection Study, Davis et al, Physiologia 2022, 2(3), 109-120