Allogeneic BM-MSC's in Patients With Lumbar Facet Arthropathy
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|ClinicalTrials.gov Identifier: NCT06001853|
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : October 3, 2023
|Condition or disease||Intervention/treatment||Phase|
|Facet-Mediated Low Back Pain||Drug: BM-MSC injection Drug: DSMO Injection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||After confirming eligibility, patients will be randomized to Arm A: Treatment or Arm B: DMSO. After 12 months, patients randomized to Arm B: DMSO will be unblinded and cross-over to Arm A: treatment then be followed for 12 months.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||This is a double-blind study. Patients and providers will be blinded. After 12 months, patients randomized to Arm B: DMSO will be unblinded and 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.|
|Official Title:||Cellkine: Phase II Study Evaluating Safety and Preliminary Efficacy of Allogeneic, Culture-Expanded Bone Marrow-Derived Mesenchymal Stem Cells in Subjects With Painful Lumbar Facet Joint Arthropathies|
|Estimated Study Start Date :||October 2023|
|Estimated Primary Completion Date :||July 2026|
|Estimated Study Completion Date :||July 2026|
Active Comparator: Arm A Treatment
Participants in Arm A will be scheduled for a single set of intra-articular injections of allogeneic, culture-expanded BM-MSCs at the dose 10 x106 in 1 ml per facet joint, for a total of 2 joints to be injected. BM-MSC injections will be performed using fluoroscopic guidance.
Drug: BM-MSC injection
BM-MSCs at the dose 10 x 106 in 1 ml per facet joint for a total of 2 joints
Placebo Comparator: Arm B: DMSO Crossover
Participants in Arm B will receive a DMSO injection. Following the BM-MSC or DMSO injection, each subject will be followed for study endpoints using a predetermined protocol. A final visit for evaluation and imaging will be conducted at the end of the study.
Drug: DSMO Injection
After 12 months, patients randomized to Arm B: DMSO will be unblinded and re-assigned to Arm A: treatment then be followed for 12 months.
- Clinical assessment of nature, incidence, and severity of adverse events (AEs) [ Time Frame: 24 months ]Clinical examination face-to-face during follow-up visits
- Self-reported assessment of nature, incidence, and severity of AEs [ Time Frame: 24 months ]Spontaneous subject reports
- Study personnel assessment of nature, incidence, and severity of AEs [ Time Frame: 24 months ]Subject interview by study personnel
- Narcotic Use Questionnaire [ Time Frame: 24 months ]Self-reported questionnaire to assess narcotic intake. Four questions to record narcotic drug usage (yes or no), frequency and length.
- Work Status Questionnaire [ Time Frame: 24 months ]Self-reported short questionnaire to assess work status at present. Simple 3 questions to record ability to work and to attend to work.
- PROMIS-CAT [ Time Frame: 24 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.
- Changes from baseline evaluated by MRI [ Time Frame: 24 months ]Facet anatomical structures with focus on effusion, bone marrow lesions and peri-articular edema, osteophytes and degree of facet synovitis will be assessed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06001853
|Contact: Wenchun Wu, MD, PhD||904-956-3043||Qu.Wenchun@Mayo.edu|
|Contact: Katie Siebenaler||904-953-4915||Siebenaler.Katie@Mayo.edu|
|United States, Florida|
|Mayo Clinic in Florida||Recruiting|
|Jacksonville, Florida, United States, 32224|
|Contact: Katie Siebenaler 904-953-4915 Siebenaler.Katie@mayo.edu|
|Principal Investigator:||Wenchun Qu, MD, PhD||Mayo Clinic|