Adipose-derived stem cell injection for Lumbar Osteoarthritis

Phase-Based Progress Estimates
Sports and Orthopedic Center, Coral Springs, FLLumbar OsteoarthritisAdipose-derived stem cell injection - Device
18 - 75
All Sexes
What conditions do you have?

Study Summary

This trial is testing a new way to treat back pain that is caused by arthritis in the facet joints.

Eligible Conditions
  • Lumbar Facet Osteoarthritis

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 6, 12, 26, 52 weeks

52 weeks
Safety - Incidence of Treatment-Emergent Adverse Events experimental group
Week 52
Efficacy - Change in Pain Scores on the VAS Scale at All Follow-up Visits
Week 52
Efficacy - Change in Function Scores on the EQ-5D at All Follow-up Visits
Efficacy - Change in Function Scores on the Oswestry Disability Index at All Follow-up Visits

Trial Safety

Trial Design

2 Treatment Groups

Corticosteroid injection
1 of 2
Adipose-derived stem cell injection
1 of 2

Active Control

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Adipose-derived stem cell injection · No Placebo Group · N/A

Adipose-derived stem cell injection
Experimental Group · 1 Intervention: Adipose-derived stem cell injection · Intervention Types: Device
Corticosteroid injection
ActiveComparator Group · 1 Intervention: Corticosteroid injection · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6, 12, 26, 52 weeks

Who is running the clinical trial?

Sanford HealthOTHER
44 Previous Clinical Trials
61,914 Total Patients Enrolled
InGeneron, Inc.Lead Sponsor
8 Previous Clinical Trials
749 Total Patients Enrolled
Thomas Boetel, MDPrincipal InvestigatorSanford Health

Eligibility Criteria

Age 18 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been experiencing pain that rates at least 4 out of 10 on a pain scale for 24 hours.
You have a medical condition called "symptomatic facet joint syndrome", which is defined by a list of specific symptoms that you have.
You have been experiencing back pain for at least 6 months.

Who else is applying?

What state do they live in?
What site did they apply to?
Sports and Orthopedic Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

Is enrollment for this trial ongoing?

"According to, this trial is still enlisting participants as of May 16th 2022. It was initially published on December 7th 2018 and has been updated since then." - Anonymous Online Contributor

Unverified Answer

Could I join the research project?

"This trial is looking for 40 individuals between 18 and 75 years old who are suffering from arthrosis. Essential requirements include: both male and female participants, a minimum of 6 months of chronic low [back pain]( treatment with conservative measures such as medications or physical therapy, radiographic evidence of an alteration in spinal morphology at the symptom level, a baseline pain score on a 0-10 scale that exceeds 4 over 24 hours., relief after diagnostic injection exceeding 80%, willingness to participate willingly throughout the study period indicated by signed informed consent." - Anonymous Online Contributor

Unverified Answer

To what extent is enrollment in this clinical trial progressing?

"Absolutely, according to this research trial is actively recruiting patients as of May 16th 2022. The study was initially posted on December 7th 2018 and seeks 40 participants from 1 medical site." - Anonymous Online Contributor

Unverified Answer

Does this research initiative embrace subjects aged 35 and up?

"The ages of participants admitted into this clinical trial range from 18 to 75. Additionally, there are 30 trials for minors and 583 trials open to seniors." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.