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Stem Cell Therapy
BM-MSC Injection for Low Back Pain
Phase 2
Recruiting
Led By Wenchun Qu, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmation of facet joint related pain by medial branch block with positive results
Low back pain for at least 6 months;
Must not have
Average baseline morphine equivalent dose (MED) of > 50mg/day
Presence of specific spinal deformities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Summary
This trial looks at if bone marrow stem cells can reduce low back pain.
Who is the study for?
This trial is for adults with chronic low back pain lasting at least 6 months, diagnosed with facet joint arthropathy between L1-S1. Participants must not be pregnant, agree to use contraception, and have no recent back procedures or biological treatments. They should understand the study and consent to participate.
What is being tested?
The trial is testing the safety and effectiveness of bone marrow-derived stem cell (BM-MSC) injections compared to DMSO injections in treating lower back pain caused by facet joint arthropathy.
What are the potential side effects?
Potential side effects may include discomfort at injection site, infection risk from the procedure, allergic reactions to injected substances, and possible temporary increase in back pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My back pain was confirmed to be from facet joints by a successful nerve block test.
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I have had low back pain for at least 6 months.
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I have been diagnosed with painful joint issues in my lower back.
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I have been diagnosed with painful joint issues in my lower back.
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My lower back pain is moderate and if I have leg pain, it's mild.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I take more than 50mg of pain medication daily.
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I have certain spine deformities.
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I had surgery on my spine or near the painful area in my back within the last year.
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I am on medication that weakens my immune system or have a condition that does so.
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I cannot have an MRI or do not want to undergo certain imaging tests.
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I currently have an infectious disease.
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I have unexplained fever or confusion.
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I have or had a spinal infection where I feel pain or an ongoing infection in my body.
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My BMI is over 40.
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I currently have or recently had a broken spine.
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I do not have serious heart, brain, kidney, liver, or hormone-related diseases.
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I have severe osteoporosis with a fracture caused by the condition.
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I have an active cancer or had cancer, except for certain removed cancers.
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I had successful radiofrequency ablation treatment at the target area within the last month.
Select...
I have had a lumbar facet injection with steroids in the last month, except for certain injections given more than 2 weeks ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical assessment of nature, incidence, and severity of adverse events (AEs)
Narcotic Use Questionnaire
PROMIS-CAT
+3 moreSecondary study objectives
Changes from baseline evaluated by MRI
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Arm A TreatmentActive Control1 Intervention
Participants in Arm A will be scheduled for a single set of intra-articular injections of allogeneic, culture-expanded BM-MSCs at the dose 10 x106 in 1 ml per facet joint, for a total of 2 joints to be injected. BM-MSC injections will be performed using fluoroscopic guidance.
Group II: Arm B: DMSO CrossoverPlacebo Group1 Intervention
Participants in Arm B will receive a DMSO injection. Following the BM-MSC or DMSO injection, each subject will be followed for study endpoints using a predetermined protocol. A final visit for evaluation and imaging will be conducted at the end of the study.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,344 Previous Clinical Trials
3,062,363 Total Patients Enrolled
Wenchun Qu, MD, PhDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
20 Total Patients Enrolled
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