Actively Recruiting

Phase 1
Age: 20Years +
All Genders
ID06361485

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

Led by R3 Stem Cell · Updated on 2024-04-11

100

Participants Needed

4

Research Sites

52 weeks

Total Duration

On this page

Sponsors

R

R3 Stem Cell

Lead Sponsor

R

R3 Medical Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and feasibility of using umbilical cord Wharton's Jelly (WJ) allograft injections for people suffering from chronic low back pain. This pilot study is open label and non-controlled, involving 100 participants. It aims primarily to assess safety while also monitoring pain relief and functional improvements over one year. Participants will receive a series of lumbar injections containing 10cc of WJ allograft. There is no control group, and the study is designed as a phase 1 trial. The treatment involves minimal manipulation of umbilical cord tissue delivered directly to the lumbar area as described in the protocol. Throughout the study, participants will undergo baseline assessments including outcome questionnaires, imaging, and laboratory tests. Safety and efficacy will be monitored through blood tests for inflammation and organ function at baseline and multiple follow-up points up to one year. Pain and function will also be tracked using various surveys and scales at scheduled intervals. The total study duration for each participant is one year.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be over age 20.
  • Suffering from chronic lumbar pain.
  • Body Mass Index (BMI) less than 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 use contraceptive measures and not plan pregnancy during the study.
  • Willing and capable of giving written informed consent in English.
  • Willing and capable of complying with study-related requirements, procedures, and visits.
Not Eligible

You will not qualify if you...

  • Taken any pain medication including NSAIDs within 2 weeks prior to study injection.
  • Use anticoagulants, have substance abuse history, or fail to agree not to take lumbar symptom modifying drugs without reporting.
  • Known allergy to penicillin, sulfa, or amphotericin medications.
  • Had any lumbar injections in the past 6 months.
  • Had lumbar spine surgery within the past 6 months.
  • Had a traumatic lumbar spine injury within the past 3 months.
  • Planned elective surgery during the study.
  • History of organ or hematologic transplantation, rheumatoid arthritis, or other autoimmune disorders.
  • On immunosuppressive medications.
  • Diagnosis of carcinoma within the past 5 years.
  • Lumbar infection or antibiotics for lumbar infection within the past 3 months.
  • Participation in any clinical study or treatment with investigational product within 30 days prior.
  • Female participants who are breastfeeding, pregnant, or desire pregnancy during the study.
  • Contraindications to radiographic or MRI imaging.
  • Serious neurological, psychological, or psychiatric disorders.
  • Injury or disability claims under current litigation or workers compensation claims pending or approved.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment session

Participants receive a series of lumbar injections with 10cc of Umbilical Cord Wharton's Jelly Allograft.

1 treatment visit (in-person)

Follow-up

Duration - 1 year

Participants are followed for one year for evaluation of safety, pain relief, and functional improvements with regular assessments.

Visits at 24 hours, 1 week, 6 weeks, 3 months, 6 months, and 1 year after treatment

Trial Site Locations

Total: 4 locations

1

R3 Anti Aging Scottsdale

Scottsdale, Arizona, United States, 85262

Actively Recruiting

2

R3 Anti Aging Beverly Hills

Beverly Hills, California, United States, 90210

Actively Recruiting

3

Scheer Medical Wellness

New York, New York, United States, 10036

Actively Recruiting

4

Dr. Duc (Steve) Le, MD

Cleveland, Texas, United States, 77327

Actively Recruiting

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Research Team

D

David L Greene, MD, PhD, MBA

K

Katherine Minter-Dykhouse, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Complications in lumbar fusion surgery for chronic low back pain: comparison of three surgical techniques used in a prospective randomized study. A report from the Swedish Lumbar Spine Study Group.

Peter Fritzell, Olle Hägg, Anders Nordwall...

https://pubmed.ncbi.nlm.nih.gov/12709856