Recruiting
Phase 1

Umbilical Cord Allograft

Sponsor:

R3 Stem Cell

Code:

NCT06361485

Conditions

Low Back Pain

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Interventions

Lumbar Injections with 10cc's of Wharton's Jelly Allograft

Study Details

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.

Conditions

Low Back Pain

Study ID

NCT06361485

Start date

Mar 25, 2024

Status verified date

Apr, 2024

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lumbar Injection Arm

Lumbar Injections with 10cc's of Umbilical Cord Wharton's Jelly Allograft (BelloWJY)

Interventions

Lumbar Injections with 10cc's of Wharton's Jelly Allograft

Low Back Injections with Minimal Manipulation Umbilical Cord Tissue

Primary outcome measure

  • C-reactive protein [ Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year ]
  • Erythrocyte sedimentation rate [ Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year ]
  • Alanine transaminase (ALT) [ Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year ]
  • Aspartate transaminase (AST) [ Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year ]
  • Alkaline phosphatase (ALP) [ Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year ]
  • Albumin [ Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year ]
  • Creatinine [ Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year ]
  • Blood Urea Nitrogen (BUN) [ Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year ]

Central Contacts and Locations

Central contacts

David L Greene, MD, PhD, MBA

(602) 677-8981dgreene@r3medicalresearch.com

Katherine Minter-Dykhouse, PhD

4803066256kmd@bello.bio

Locations

R3 Anti Aging Scottsdale

Recruiting

Scottsdale, Arizona, United States, 85262

Contacts

David Greene, MD, PhD, MBA

480-306-6256dgreene@r3medicalresearch.com

Principal Investigator:

Sabrina Solt, NMD

R3 Anti Aging Beverly Hills

Recruiting

Beverly Hills, California, United States, 90210

Contacts

Kathleen Francesca, BA

424-382-1074kfrancesca@r3stemcell.com

Principal Investigator:

Neville Campbell, MD

Scheer Medical Wellness

Recruiting

New York, New York, United States, 10036

Contacts

Alexandre Scheer, MD

646-762-9499ascheer911@gmail.com

Principal Investigator:

Alexandre Scheer, MD

Dr. Duc (Steve) Le, MD

Recruiting

Cleveland, Texas, United States, 77327

Contacts

Steve Le, MD

281-593-1500ducstevele@gmail.com

Principal Investigator:

Steve Le, MD

More Information

Sponsor

R3 Stem Cell

Last update posted

Apr 11, 2024

Last verified

Apr, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by R3 Stem Cell on 2024-04-11.