← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Cellkine Trial 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.Check my eligibility
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.See study design
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.

Cellkine Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My back pain was confirmed to be from facet joints by a successful nerve block test.
Select...
I have been diagnosed with painful joint issues in my lower back.
Select...
I have chronic low back pain that may spread to my buttock, groin, or upper thigh.
Select...
I am between 40 and 70 years old.

Cellkine Trial 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

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)
Self-reported assessment of nature, incidence, and severity of AEs
Study personnel assessment of nature, incidence, and severity of AEs
Secondary outcome measures
Aspartate Transaminase
Change in Blood Urea Nitrogen (BUN)
Change in Carbon Dioxide
+18 more

Cellkine 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
3,176 Previous Clinical Trials
3,758,041 Total Patients Enrolled
10 Trials studying Low Back Pain
251,486 Patients Enrolled for Low Back Pain
Wenchun Qu, MD, PhDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital Jacksonville
2 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Low Back Pain
40 Patients Enrolled for Low Back Pain

Media Library

Allogeneic BM-MSCs (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04410731 — Phase 1
Low Back Pain Research Study Groups: BM-MSC injections for low back pain
Low Back Pain 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

Frequently Asked Questions

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

Are persons aged 30 and over eligible to join this experiment?

"This particular trial is looking to recruit patients who are between 40 and 70 years old. For those seeking medical studies with younger or more elderly participants, there are 19 trials involving people under 18 and 332 for those over 65."

Answered by AI

Are there any restrictions on who can participate in this experiment?

"This research project is recruiting 10 individuals aged 40 - 70 who experience chronic low back pain with or without radiculopathy in the buttock, groin, and proximal thigh regions."

Answered by AI

Has the FDA authorized single bilaterally-administered injections of allogeneic bone marrow stem cells for lumbar facet joint arthropathy?

"Our team at Power gauged the safety of Single bilateral intra-articular injection of allogeneic BM-MSCs for lumbar facet joint arthropathy to be a 1 since it is in Phase 1, with minimal data affirming its efficacy and security."

Answered by AI

What objectives does this clinical trial seek to achieve?

"This two-year assessment is primarily focused on measuring the adverse effects that could be associated with this treatment. Secondary metrics also comprise of changes in AST levels (a serological test to measure liver enzyme activity), a self-reported Narcotic Use questionnaire, and platelet count (another laboratory analysis)."

Answered by AI

Is enrollment ongoing in this experiment?

"Confirmed, this trial is not actively enrolling patients. Initially published on April 28th 2020 and last edited May 11th 2022, there are no current recruitment efforts in place; however 412 other medical studies are currently seeking participants."

Answered by AI
~0 spots leftby Apr 2024