Injections of Wharton's Jelly for treating low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study evaluates the safety and feasibility of umbilical cord Wharton's Jelly allograft injections in 100 participants suffering from chronic lumbar pain. Participants will receive a series of lumbar injections and will be monitored for one year to assess safety, pain relief, and functional improvements. The study is open label and non-controlled, focusing on the effects of the treatment without a comparison group.

Why it matters

Who can join: the full rules

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.

Where it's running

• R3 Anti Aging Scottsdale
  Scottsdale, Arizona, United States Recruiting
• R3 Anti Aging Beverly Hills
  Beverly Hills, California, United States Recruiting
• Scheer Medical Wellness
  New York, New York, United States Recruiting
• Dr. Duc (Steve) Le, MD
  Cleveland, Texas, United States Recruiting

Study contacts

• Study coordinator: David L Greene, MD, PhD, MBA
• Email: dgreene@r3medicalresearch.com
• Phone: (602) 677-8981

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.