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Stem Cell Therapy

Wharton's Jelly Injections for 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
No Placebo-Only Group

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.
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.
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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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)

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Who is running the clinical trial?

R3 Stem CellLead Sponsor
2 Previous Clinical Trials
5,200 Total Patients Enrolled
R3 Medical ResearchIndustry Sponsor
1 Previous Clinical Trials
120 Total Patients Enrolled
James Faber, BAStudy ChairInstitute of Cellular and Regenerative Medicine IRB
~67 spots leftby Mar 2027
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