Facet-Mediated Low Back Pain, Lumbar Facet Joint Osteoarthritis
Conditions
Brief 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.
Detailed description
This study is a prospective, double blinded, randomized, cross over phase II study evaluating efficacy and safety of intra-articularly injected BM-MSCs in the treatment of painful facet joint arthropathy (FJA). Patients with mild to severe facet arthropathy will be considered for this study. A total of 40 patients with diagnosis evidence of chronic low back pain associated with FJA and positive outcome of a MBB will be recruited. After confirming eligibility, patients will be randomized to Arm A: Treatment or Arm B: DMSO. After 6 months, patients randomized to Arm B: DMSO will be unblinded and may cross-over to Arm A: treatment then be followed for 12 months.
Interventions
DRUGBM-MSC injection
BM-MSCs at the dose 10 x 106 in 1 ml per facet joint for a total of 2 joints
DRUGDSMO Injection
After 6 months, patients randomized to Arm B: DMSO will be unblinded and re-assigned to Arm A: treatment then be followed for 12 months.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
This is a double-blind study. Patients and providers will be blinded. After 6 months, patients randomized to Arm B: DMSO will be unblinded and may crossed over to Arm A: treatment then be followed for 12 months. The statistician will generate the randomization list. Research personnel involved in patient recruitment and other activities will have no access to the randomization list.
Intervention model description
After confirming eligibility, patients will be randomized to Arm A: BM-MSC or Arm B: DMSO. After 6 months, patients randomized to Arm B: DMSO will be unblinded and may cross-over to Arm A: treatment then be followed for 12 months or continue with Arm B for another 6-month follow-up without BM-MSC injections. All patients will be followed up to 12 months after BM-MSCs.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be eligible for inclusion into this study, the subjects must fulfill all the following criteria: 1. Male or female subjects ages 18 and older 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 12 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. 2. Clinical diagnosis of symptomatic facet joint arthropathy involving the L1-S1 facets. 3. Radiographic evidence of facet arthropathy involving the L1-S1 facets. 4. Chronic low back pain with or without referred pain to the buttock, groin, or proximal thigh. Chronic low back pain is defined as the following: * Low back pain for at least 6 months * Subjects should be treated with currently available standard therapies prior to receiving an investigational product, and only subjects who do not have an adequate response to standard therapies. Have at a minimum undergone supervised physical therapy, such as daily walking routines, therapeutic exercises, and back education programs specifically for the treatment of low back pain AND taken a pain medication for back pain (e.g. NSAID and/or opioid medication). * Low back pain of at least 3 to 9 on numeric rating scale (NRS) (average pain in the past 7 days). 5. Confirmation of facet joint related pain by double medial branch blocks with positive results. Positive results are defined as at 75% or more improvement on pain. 6. 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. 7. Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure.
Exclusion criteria
Subjects will be excluded from participating in the study if they meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical assessment of nature, incidence, and severity of adverse events (AEs) | Up to 18 months | Clinical examination face-to-face during follow-up visits |
| Self-reported assessment of nature, incidence, and severity of AEs | Up to 18 months | Spontaneous subject reports |
| Study personnel assessment of nature, incidence, and severity of AEs | Up to 18 months | Subject interview by study personnel |
| PROMIS-CATs | Up to 18 months | Patient-Reported Outcomes Measurement Information System to evaluate and monitor physical, mental, and social health. Standardized response scores ranges vary from1 to 5 (e.g., 1= None to 5=Very severe) or reversed (5=None to 1=Very severe) to ensure that higher scores for responses always indicate better health. |
| Numeric Rating Scale (NRS) for low back pain | Up to 18 months | A visual scale of 0 being "no pain" and 100 being "worst pain Imaginable'" to assess pain status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline evaluated by MRI | Up to 18 months | Facet anatomical structures with focus on effusion, bone marrow lesions and peri-articular edema, osteophytes and degree of facet synovitis will be assessed |
| Narcotic Use Questionnaire | Up to 18 months | Self-reported questionnaire to assess narcotic intake. Four questions to record narcotic drug usage (yes or no), frequency and length. |
| Work Status Questionnaire | Up to 18 months | Self-reported short questionnaire to assess work status at present. Simple 3 questions to record ability to work and to attend to work. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWenchun Qu, MD, PhD
Mayo Clinic
Outcome results
None listed