CompletedPhase 1

Allogeneic BM-MSCs in Patients with Lumbar Facet Arthropathy

United States10 participantsStarted 2020-04-28

Plain-language summary

Researchers are conducting this study to learn more about the side effects of bone marrow-derived stem cells when injected into the facet joints for the treatment of painful lumbar facet joint arthropathies.

Who can participate

Age range

40 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Persons of childbearing potential must be non-nursing and have a negative serum pregnancy test to be included in the trial and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 24 months following completion of the drug treatment cycle.
. Clinical diagnosis of symptomatic facet joint arthropathy involving the L3-S1 facets.
. Radiographic evidence of facet arthropathy involving the L3-S1 facets.
. Chronic low back pain with or without referred pain to the buttock, groin, or proximal thigh.
. Confirmation of facet joint related pain by medial branch block with positive results.
. Full understanding of the requirements of the study and willingness to comply with the treatment plan, including laboratory tests, diagnostic imaging, and follow-up visits and assessments.
. Can provide written informed consent.

Exclusion criteria

. Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI \> 40)
. Subjects who are pregnant or nursing or subjects planning to become pregnant in the first 24 months post-treatment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 24 months

Self-reported assessment of nature, incidence, and severity of AEs

Timeframe: 24 months

Study personnel assessment of nature, incidence, and severity of AEs

Timeframe: 24 months

Trial details

NCT IDNCT04410731

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-15

View on ClinicalTrials.gov More Facet-Mediated Low Back Pain trials

Who can participate

Age range

40 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Persons of childbearing potential must be non-nursing and have a negative serum pregnancy test to be included in the trial and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 24 months following completion of the drug treatment cycle.
. Clinical diagnosis of symptomatic facet joint arthropathy involving the L3-S1 facets.
. Radiographic evidence of facet arthropathy involving the L3-S1 facets.
. Chronic low back pain with or without referred pain to the buttock, groin, or proximal thigh.
. Confirmation of facet joint related pain by medial branch block with positive results.
. Full understanding of the requirements of the study and willingness to comply with the treatment plan, including laboratory tests, diagnostic imaging, and follow-up visits and assessments.
. Can provide written informed consent.

Exclusion criteria

. Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI \> 40)
. Subjects who are pregnant or nursing or subjects planning to become pregnant in the first 24 months post-treatment.