Allogeneic BM-MSC's in Patients With Lumbar Facet Arthropathy (NCT06001853) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Allogeneic BM-MSC's in Patients With Lumbar Facet Arthropathy
United States40 participantsStarted 2023-11-03
Plain-language summary
The purpose of this research study is to evaluate the safety and effect of bone marrow-derived stem cells for the treatment of low back pain.
Who can participate
Age range18 Years
SexALL
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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 up to 18 months following completion of the drug treatment cycle. Persons of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered, and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using a kit. Persons becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcomes. Any SAEs associated with pregnancy will be recorded. The requirement for radiation (X-ray) will be removed.
* Clinical diagnosis of symptomatic facet joint arthropathy involving the L1-S1 facets.
* Radiographic evidence of facet arthropathy involving the L1-S1 facets.
* Chronic low back pain with or without referred pain to the buttock, groin, or proximal thigh.
* Chronic low back pain is …
What they're measuring
1
Clinical assessment of nature, incidence, and severity of adverse events (AEs)
Timeframe: 24 months
2
Self-reported assessment of nature, incidence, and severity of AEs
Timeframe: 24 months
3
Study personnel assessment of nature, incidence, and severity of AEs