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Stem Cell Therapy
Stem Cell Injection for Osteoarthritis
N/A
Recruiting
Led By Thomas Boetel, MD
Research Sponsored by InGeneron, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and female subjects, between 18 and 75 years of age.
Have documented the diagnosis of facet joint osteoarthritis from L1 to S1 in the opinion of the investigator.
Timeline
Screening 2 weeks
Treatment Varies
Follow Up 3 days
Awards & highlights
Study Summary
This trial is testing a new way to treat back pain that is caused by arthritis in the facet joints.
Who is the study for?
Adults aged 18-75 with chronic lower back pain due to facet joint osteoarthritis, who have not improved after 3 months of conservative care and physical therapy. Participants must have a baseline pain score of at least 4 out of 10 and show significant pain relief after a diagnostic injection. Exclusions include active cancer, high risk for bleeding or infection, severe autoimmune diseases, recent drug abuse, pregnancy or nursing women, extreme obesity (BMI >40), and certain medication use.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of injecting Adipose-derived Regenerative Cells (ADRC) compared to corticosteroid injections in treating lower back pain caused by osteoarthritis in the facet joints. It's randomized and controlled to ensure reliable results.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site such as pain or swelling, increased risk of infection due to stem cell manipulation, allergic reactions to components used during procedures like contrast agents or local anesthetics.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
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My doctor has confirmed I have arthritis in my lower back joints.
Select...
I have been diagnosed with symptomatic facet joint syndrome.
Select...
I've tried various non-surgical back pain treatments for 3 months without improvement.
Select...
My pain level is at least 4 out of 10 over a day.
Timeline
Screening ~ 2 weeks2 visits
Treatment ~ Varies
Follow Up ~ 3 days5 visits
Screening ~ 2 weeks
Treatment ~ Varies
Follow Up ~3 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety - Incidence of Treatment-Emergent Adverse Events experimental group
Secondary outcome measures
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
Efficacy - Change in Pain Scores on the VAS Scale at All Follow-up Visits
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Adipose-derived stem cell injectionExperimental Treatment1 Intervention
ADRC treatment group will receive ADRCs yielded from processing of lipoaspirate by a fluoroscopic-guided injection into the affected segment. The segment will consist of 2 joints per level and up to two levels (no more than 4 joints) injected during the procedure.
Group II: Corticosteroid injectionActive Control1 Intervention
The control group will undergo standard fluoroscopy guided injection of glucocorticoids and local anesthetics.
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Sanford HealthOTHER
48 Previous Clinical Trials
61,883 Total Patients Enrolled
2 Trials studying Osteoarthritis
290 Patients Enrolled for Osteoarthritis
InGeneron, Inc.Lead Sponsor
8 Previous Clinical Trials
671 Total Patients Enrolled
1 Trials studying Osteoarthritis
40 Patients Enrolled for Osteoarthritis
Thomas Boetel, MDPrincipal InvestigatorSanford Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 75 years old.I am a woman who can have children and I use or plan to use birth control during the study.I haven't had any lower back injections in the last 3 months, except for certain ones over 2 weeks ago.I am currently taking NSAIDs.I am not allergic to common local anesthetics like lidocaine.I am not currently taking antibiotics.I am okay with using saline in my treatment.I've been on steroids equivalent to 10 mg of prednisone daily for over a week.I have received stem cell therapy or biological treatment for my spine.I take more than 40mg of pain medication daily.I am at high risk for bleeding or infection according to my doctor.I have never had a spinal infection or any active infection in my body.I do not have severe or long-term pain that could affect spine pain assessments.I am part of a group that might not fully understand or agree to the study on my own.I have significant nerve or sacroiliac joint pain confirmed by a doctor.I have severe lower back pain due to a nerve being pinched in my spine.I have back or neck pain due to spinal narrowing.My condition may require surgery to stabilize my body, as per my doctor's advice.I have a recent spine fracture or damaged vertebrae from past injuries.I have leg pain that spreads from my spine.My doctor diagnosed me with arthritis in my lower back joints.I have been diagnosed with symptomatic facet joint syndrome.I have had chronic low back pain for at least 6 months.I have participated in physical therapy for my low back pain.My doctor has confirmed I have arthritis in my lower back joints.I have been diagnosed with symptomatic facet joint syndrome.I have completed physical therapy for my low back pain.I have had chronic low back pain for at least 6 months.You have lumbar facet joint osteoarthritis.I've tried various non-surgical back pain treatments for 3 months without improvement.I have tried various non-surgical treatments for back pain for 3 months without improvement.I have had a contrast dye injection for imaging tests.I haven't had cancer in the last 2 years, except for certain skin or cervical cancers that were fully removed.I have cauda equina syndrome.I failed part of my initial spine nerve function test.I am on immunosuppressant therapy or have a severe autoimmune disease.I don't have enough body fat to safely remove 100 mL of it.I am between 18 and 75 years old.I have tried various non-surgical back pain treatments for 3 months without improvement.My pain level is at least 4 out of 10 over the last day.I am not pregnant, nursing, or planning to become pregnant within a year after treatment.I haven't had any spinal injections or nerve treatments in the last 8 weeks.My pain level is at least 4 out of 10 over a day.My doctor has confirmed I have arthritis in my lower back joints.I have had chronic low back pain for at least 6 months.I am between 18 and 75 years old.I have completed a physical therapy program for my low back pain.
Research Study Groups:
This trial has the following groups:- Group 1: Corticosteroid injection
- Group 2: Adipose-derived stem cell injection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 1 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT03513731 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this trial ongoing?
"According to clinicaltrials.gov, 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."
Answered by AI
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."
Answered by AI
To what extent is enrollment in this clinical trial progressing?
"Absolutely, according to clinicaltrials.gov 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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Sports and Orthopedic Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I have bone on bone knee. I’ve tried other things to no avail.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Is this stem cell therapy?
PatientReceived no prior treatments
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