A Prospective Pilot Study in Treating Chronic Degenerated Facet Low Back Pain
Study Details
Study Description
Brief Summary
The study format is a prospective non-randomized study to be conducted at a single site. Up to twenty consecutive DFLBP patients meeting the inclusion and exclusion criteria and who provide informed consent will be enrolled in the study. The patients will receive treatment compliant with national guidelines. Appropriate patients will be injected with 0.5cc of ExoFlo into each of their affected facet joint(s). The facets to be treated will be determined by imaging and Dr. Wilson. Up to three vertebral levels can be treated. Patients will be assessed with pre and post-treatment physical examination. At baseline, Brief Pain Inventory (BPI) and Visual Analogue Scale (VAS) will be documented. BPI and VAS scoring will be collected at 24 hours, 3 days, 7 days, 1 month, 2 months and 3 months after each treatment. Adverse events will be monitored by follow-up phone calls at 24, 48 hours, 1 week after the procedure and at all follow-up visits. Patients drug usage will be monitored. Patient will be instructed to call the office any time after treatment if they are experiencing any adverse events. A patient can leave the study at any time.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: No SAE attributable to IP in clinical investigational use to date
|
Drug: Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment
All patients will be monitored for the presence of any adverse events during their facet injection of 0.5cc ExoFlo into up to three vertebral levels as well as on routine or unanticipated office visits or calls. All adverse events and complication will be documented.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Primary endpoint is an intense evaluation of ANY adverse events to establish a safety profile for ExoFlo to treat DFLBP. [70 weeks]
Primary endpoint is an intense evaluation of ANY adverse events to establish a safety profile for ExoFlo to treat DFLBP.
Secondary Outcome Measures
- A measured change in the treatments and/or drugs taken prior and after the single ExoFlo facet injection. Measurements will include improvements in ODI at each follow-up point. [70 weeks]
A measured change in the treatments and/or drugs taken prior and after the single ExoFlo facet injection. Measurements will include improvements in ODI at each follow-up point.
- A measured change in the treatments and/or drugs taken prior and after the single ExoFlo facet injection. Measurements will include improvements in BPI at each follow-up point. [70 weeks]
A measured change in the treatments and/or drugs taken prior and after the single ExoFlo facet injection. Measurements will include improvements in BPI at each follow-up point.
Eligibility Criteria
Criteria
Inclusion Criteria: All candidates for this study must meet ALL of the following Inclusion
Criteria to be eligible for enrollment:
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Voluntary signature of the approved Informed Consent
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Subject must be over 18 years old.
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A minimum 6-month diagnosis of DFLBP defined based on INCLUSION criteria.
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The DFLBP can be from any etiology.
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The patient must be currently on regular treatments and/or medications for their DFLBP diagnosis.
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MRI evidence of one or up to three levels of facet degeneration.
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Primary symptom complaint of degenerated facet caused low back pain. This will be established by MRI imaging documenting facet degeneration and a diagnostic image guided facet injection of an anesthetic that provides the patient at least a 70% reduction of their LBP for a period of time appropriate for the anesthetic used.
Exclusion Criteria: Candidates who meet ANY of the following Exclusion Criteria at the time of the study procedure are NOT eligible for enrollment in the study:
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The subject is unable to conform to the study protocol follow-up procedures and visits.
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The subject has major risk factors such as a history of narcotic abuse, paucity of family support, unemployed, history of previous physical or mental abuse or severe medical comorbidities.
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Patients with any auto-immune disorder.
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Any patient felt not to be a suitable study patient by the principal Investigator.
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Radiographic evidence of spondylolysis or spondylolisthesis.
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Symptomatic stenosis or disc herniation resulting in leg greater than back pain.
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Symptomatic discogenic pain.
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Patients with hematologic blood dyscrasias, platelet dysfunction, septicemia/fever, malignancy, cutaneous infections in area to be treated or severe psychiatric impairment or unrealistic expectations.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Direct Biologics | Austin | Texas | United States | 78746 |
Sponsors and Collaborators
- Direct Biologics, LLC
Investigators
- Study Chair: Vikram Sengupta, MD, Direct Biologics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRCM-2021-282