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Stem Cell Therapy

Lumbar Injection Arm for Lower Back Pain

Phase 1
Recruiting
Research Sponsored by R3 Stem Cell
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
Awards & highlights

Study Summary

"This trial is a small preliminary study where 100 people with low back pain will receive Wharton's Jelly allograft to see if it is safe and possible to use."

Who is the study for?
This trial is for individuals experiencing low back pain. To participate, there are no specific inclusion criteria provided, but participants will likely need to meet certain health standards as determined by the study's protocol.Check my eligibility
What is being tested?
The trial is testing the safety and feasibility of injecting 10cc's of Wharton's Jelly Allograft into the lumbar (lower back) region in people with back pain. It’s an open-label and non-controlled pilot study involving 100 participants.See study design
What are the potential side effects?
Since this is a pilot study focused on safety and feasibility, potential side effects may not be fully known yet. However, common risks could include injection site reactions, inflammation, or allergic responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alanine transaminase (ALT)
Albumin
Alkaline phosphatase (ALP)
+5 more
Secondary outcome measures
36-Item Short Form Survey (SF-36)
Numerical Pain Rating Scale (NPRS)
Oswestry disability index (ODI)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lumbar Injection ArmExperimental Treatment1 Intervention
Lumbar Injections with 10cc's of Umbilical Cord Wharton's Jelly Allograft (BelloWJY)

Find a Location

Who is running the clinical trial?

R3 Stem CellLead Sponsor
2 Previous Clinical Trials
5,200 Total Patients Enrolled
R3 Medical ResearchIndustry Sponsor
James Faber, BAStudy ChairInstitute of Cellular and Regenerative Medicine IRB

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial currently accepting new participants?

"Affirmative. The details on clinicaltrials.gov indicate that this specific medical trial is actively seeking suitable candidates. This trial was initially listed on March 25, 2024, and the latest update occurred on April 9, 2024. There is a need to recruit around 100 participants from four different locations for this study."

Answered by AI

What is the current number of participants being enlisted for this clinical trial?

"The trial requires a cohort of 100 individuals who satisfy the specified eligibility criteria. The research will be overseen by R3 Stem Cell and conducted at various locations, notably R3 Anti Aging Scottsdale in Scottsdale, Arizona, as well as Scheer Medical Wellness in New york City, New York."

Answered by AI

Are multiple locations within the United States involved in conducting this research?

"This research is being conducted at R3 Anti Aging Scottsdale in Scottsdale, Arizona; Scheer Medical Wellness in New york, New York; and Dr. Duc (Steve) Le, MD's practice in Cleveland, Texas among 4 additional sites."

Answered by AI

What are the anticipated results that researchers hope to achieve through this experimental investigation?

"The primary objective of this clinical trial, monitored at various intervals including a baseline and post-procedure assessments up to one year, is to evaluate the levels of Alanine transaminase (ALT). Secondary endpoints include the assessment of pain through the Numerical Pain Rating Scale (NPRS), which utilizes an 11-point scale ranging from 0 for no pain to 10 indicating extreme discomfort. Additionally, functional outcomes will be measured using the Oswestry Disability Index (ODI) questionnaire that quantifies disability on a percentage basis with higher scores reflecting greater impairment. The Roland Morris disability questionnaire (RMQ) will also be employed to gauge pain"

Answered by AI

What are the risks associated with Lumbar Injection Arm for individuals?

"The safety evaluation conducted by our team at Power rated Lumbar Injection Arm with a score of 1 due to its Phase 1 trial status, indicating minimal available data on both safety and efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Dr. Duc (Steve) Le, MD
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Muscle relaxers Ibuprofen 800 Injections.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain
2024. "Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06361485.
All > Low Back Pain > Paid Studies Pasadena
~67 spots leftby Mar 2027
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