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 range40 Years – 70 Years

SexALL

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.
✕. Subjects with current or prior history of spinal infection at the symptomatic level.
✕. Subjects with a diagnosis of severe osteoporosis with pathological fracture.
✕. Radiofrequency ablation at the index level prior to injection in the past 3 months with positive results.
✕. Any lumbar facet intra-articular injection including steroids at the index facet level prior to treatment injection in the past 3 months
✕. Subjects that have undergone a procedure affecting the structure/biomechanics of the index facet joint or a spinal fusion adjacent to the symptomatic level.
✕. Have undergone any procedure using biological treatment for any condition such as bone marrow aspirate concentrate, PRP, bone marrow-derived MSCs, adipose-derived MSCs, SVF, micro fragmented fat, embryonic membrane product etc.

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 range40 Years – 70 Years

SexALL

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.
✕. Subjects with current or prior history of spinal infection at the symptomatic level.
✕. Subjects with a diagnosis of severe osteoporosis with pathological fracture.
✕. Radiofrequency ablation at the index level prior to injection in the past 3 months with positive results.
✕. Any lumbar facet intra-articular injection including steroids at the index facet level prior to treatment injection in the past 3 months
✕. Subjects that have undergone a procedure affecting the structure/biomechanics of the index facet joint or a spinal fusion adjacent to the symptomatic level.
✕. Have undergone any procedure using biological treatment for any condition such as bone marrow aspirate concentrate, PRP, bone marrow-derived MSCs, adipose-derived MSCs, SVF, micro fragmented fat, embryonic membrane product etc.