RECRUITING

Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain

Conditions

Low Back Pain lumbago lumbar spondylosis lumbar arthritis facet syndrome umbilical umbilical cord allograft stem cell exosome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain

Quick Facts

Study Start:2024-03-25

Study Completion:2028-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06361485

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.

Contacts and Locations

Study Contact

David L Greene, MD, PhD, MBA

CONTACT

(602) 677-8981

dgreene@r3medicalresearch.com

Katherine Minter-Dykhouse, PhD

CONTACT

4803066256

kmd@bello.bio

Principal Investigator

James Faber, BA

STUDY_CHAIR

Institute of Cellular and Regenerative Medicine IRB

Study Locations (Sites)

R3 Anti Aging Scottsdale

Scottsdale, Arizona, 85262

United States

R3 Anti Aging Beverly Hills

Beverly Hills, California, 90210

United States

Scheer Medical Wellness

New York, New York, 10036

United States

Dr. Duc (Steve) Le, MD

Cleveland, Texas, 77327

United States

Collaborators and Investigators

Sponsor: R3 Stem Cell

James Faber, BA, STUDY_CHAIR, Institute of Cellular and Regenerative Medicine IRB

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-25

Study Completion Date2028-04-01

Study Record Updates

Study Start Date2024-03-25

Study Completion Date2028-04-01

Terms related to this study

Keywords Provided by Researchers

lumbago
low back pain
lumbar spondylosis
lumbar arthritis
facet syndrome
umbilical
umbilical cord allograft
stem cell
exosome

Additional Relevant MeSH Terms

Low Back Pain