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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 below

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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:

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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.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

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 more

Secondary 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.

0 / 20Eligibility criteria met