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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;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical assessment of nature, incidence, and severity of adverse events (AEs)

Narcotic Use Questionnaire

PROMIS-CAT

+3 more

Secondary outcome measures

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,448 Total Patients Enrolled

10 Trials studying Low Back Pain

251,456 Patients Enrolled for Low Back Pain

Wenchun Qu, MD, PhDPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

20 Total Patients Enrolled

1 Trials studying Low Back Pain

10 Patients Enrolled for Low Back Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available spots to join this experiment?

"Indeed, the clinicaltrials.gov registry indicates that this investigation is actively enrolling patients. It was published on September 1st 2023 and updated most recently on August 18th of the same year. This research requires 40 volunteers to be recruited from a single facility."

Answered by AI

Has the arm A treatment been granted certification from the FDA?

"Based on the evidence that is available, Arm A Treatment was given a safety score of 2. This evaluation takes into account its Phase 2 trial status which indicates some data supporting safety but not efficacy."

Answered by AI

What is the total count of participants in this research experiment?

"Affirmative. According to clinicaltrials.gov, this research is open and accepting participants; it was first advertised on September 1st 2023 before the last update dated August 18th 2023. Forty individuals are required from a single medical centre."

Answered by AI