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Stem Cell Therapy

Stem Cell Therapy for Lower Back Pain (Cellkine Trial)

Phase 1
Waitlist Available
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
Clinical diagnosis of symptomatic facet joint arthropathy involving the L3-S1 facets
Must not have
Clinically significant cardiovascular, neurological, renal, hepatic or endocrine disease
Acute fracture of the spine at the time of enrollment in the study or clinically compromised vertebral bodies at the affected level due to current or past trauma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the side effects of a stem cell treatment for a painful back condition.

Who is the study for?
This trial is for men and women aged 40-70 with chronic lower back pain diagnosed as lumbar facet joint arthropathy, confirmed by specific tests. Participants must not be pregnant or planning pregnancy soon, extremely obese, have severe osteoporosis, spinal deformities above a certain grade, recent back treatments or injections, immune system issues, or other serious health conditions.
What is being tested?
The study is testing the effects of injecting bone marrow-derived stem cells into the spine's facet joints to treat low back pain caused by arthritis in those joints. It aims to understand the side effects and potential relief offered by this single injection treatment.
What are the potential side effects?
While not explicitly listed in the provided information, typical side effects from similar procedures may include temporary increased pain at the injection site, infection risk at the puncture site, bleeding complications or allergic reactions to injected substances.

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 been diagnosed with painful joint issues in my lower back.
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I am between 40 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have serious heart, brain, kidney, liver, or hormone-related diseases.
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I currently have or recently had a broken spine.
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I have severe osteoporosis with a bone fracture.
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I have not had an epidural steroid injection in the last 4 weeks.
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I am on a high dose of pain medication.
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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 have had a treatment that uses living organisms or substances from living organisms.
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I have a significant spinal deformity.
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I've had surgery that changed the structure of my spine near the painful area.
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I have had or currently have a spinal infection.
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I have had unexplained fever or confusion recently.
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I have had cancer or symptoms from a tumor within the last 5 years.
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I currently have an infectious disease.

Timeline

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)
Self-reported assessment of nature, incidence, and severity of AEs
Study personnel assessment of nature, incidence, and severity of AEs
Secondary study objectives
Aspartate Transaminase
Change in Blood Urea Nitrogen (BUN)
Change in Carbon Dioxide
+18 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: BM-MSC injections for low back painExperimental Treatment1 Intervention
Single bilateral intra-articular injections of allogeneic BM-MSCs for lumbar facet joint arthropathy

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,342 Previous Clinical Trials
3,062,322 Total Patients Enrolled
Wenchun Qu, MD, PhDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital Jacksonville
2 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Allogeneic BM-MSCs (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04410731 — Phase 1
Facet Joint Syndrome Research Study Groups: BM-MSC injections for low back pain
Facet Joint Syndrome Clinical Trial 2023: Allogeneic BM-MSCs Highlights & Side Effects. Trial Name: NCT04410731 — Phase 1
Allogeneic BM-MSCs (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04410731 — Phase 1
~2 spots leftby Nov 2025
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