Back to resultsStudy Evaluating the Safety and Feasibility of Platelet-rich Plasma to Treat Facetogenic Low Back Pain
Primary Purpose
Lumbar Spondylosis
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Angel® Concentrated Platelet Rich Plasma System
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spondylosis focused on measuring arthritis, facet joint, lumbar spondylosis, back pain
Eligibility Criteria
Inclusion Criteria:
- Clinical and radiographic (MRI, CT or lumbar x-ray) evidence of symptomatic facet arthropathy involving the bilateral bottom two facets (e.g., L4-5 or L5-6 and L5-S1 or L6-S1).
- Positive response, defined according to current clinical standards for the diagnosis of facet-mediated low back pain as greater than or equal to 75% pain improvement (as reported by patient) to diagnostic medial branch nerve blocks, one block with lidocaine and the other with bupivacaine.
- Low back pain VAS score of greater than or equal to 5 at the clinical visit just prior to the first medial branch nerve block.
Exclusion Criteria:
- Prior facet related procedure (intraarticular corticosteroid injection, radiofrequency ablation (RFA)) in last 6 months or prior fusion in the bottom two facets.
- Current opioid use of greater than 50mg oral morphine milligram equivalents per day.
- No advanced imaging (MRI, CT or lumbar x-ray) of the lumbar spine within the last 6 months.
- BMI > 34.99 (WHO class I obesity).
- Active systemic or local infection as evidenced by fever >100.4 degrees Fahrenheit, or any other clinical signs or symptoms of infection within 24 hours of the procedure.
- On anticoagulation drug and has been on hold for less than 7 days prior to the investigational procedure.
- Imaging evidence of high likelihood of failure for intra-articular injection in the opinion of the PI or delegate review of MRI, CT or lumbar x-ray imaging.
- History of chronic thrombocytopenia (or pre-operative platelet count less than 195,000 per μl).
- Undergoing chemotherapy at time of injection.
- Pregnant or breastfeeding.
- Use of illicit drugs within 30 days prior to study entry.
- NSAID use during the pre-procedural period (one week before Treatment Day 0).
- Preoperative hematocrit less than 36%.
- History of hemodynamic instability or inability to maintain stable oncotic pressure.
- History of prolonged clotting times.
- Prior history of lumbar procedure.
- Redness, swelling, rash or other concerning lesions at the injection site just prior to the procedure.
- Prior history of allergy to lidocaine or other local anesthetic agent.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PRP Injection Arm
Arm Description
The FDA cleared Angel® Concentrated Platelet Rich Plasma System and Angel® cPRP Processing Set will be used to process the PRP. The targeted final PRP volume of 6 ml will be injected in up to 4 facet joints (2 levels) at 1.5 ml per joint.
Outcomes
Primary Outcome Measures
Number of adverse device effects
Adverse device effects related to the processing of the platelet rich plasma product (such as hardware failures/malfunctions, software errors, disposable set equipment malfunctions, processing errors, automatic self-test/calibration errors, variations in hematocrit level in final product, variations in total volume of PRP concentrate produced, etc.)
Number of suspected acute adverse reactions to the treatment
Suspected adverse reactions to the treatment based on evaluations including follow-up physical examinations, labs and assessment of clinical signs and symptoms.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05250947
Brief Title
Study Evaluating the Safety and Feasibility of Platelet-rich Plasma to Treat Facetogenic Low Back Pain
Official Title
A Phase I Study Evaluating the Safety and Feasibility of Platelet-rich Plasma for the Treatment of Facetogenic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Matthew Pingree
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is being done to assess the safety of using the Angel Concentrated Platelet Rich Plasma System to process Platelet Rich Plasma (PRP) to treat arthritis of the low back (lumbar spondylosis).
Detailed Description
This study is a pilot of the safety of using the FDA cleared Angel® Concentrated Platelet Rich Plasma System and Angel® cPRP Processing Set to process PRP to treat arthritis of the low back (lumbar spondylosis). Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained baseline values will be established and subjects will begin treatment and follow-up for the next 12 months. A final visit for evaluation and collection of lab samples will be conducted at the end of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spondylosis
Keywords
arthritis, facet joint, lumbar spondylosis, back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a pilot safety study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRP Injection Arm
Arm Type
Experimental
Arm Description
The FDA cleared Angel® Concentrated Platelet Rich Plasma System and Angel® cPRP Processing Set will be used to process the PRP. The targeted final PRP volume of 6 ml will be injected in up to 4 facet joints (2 levels) at 1.5 ml per joint.
Intervention Type
Device
Intervention Name(s)
Angel® Concentrated Platelet Rich Plasma System
Intervention Description
Angel® Concentrated Platelet Rich Plasma System and Angel® cPRP Processing Set will be used to process the PRP.
Primary Outcome Measure Information:
Title
Number of adverse device effects
Description
Adverse device effects related to the processing of the platelet rich plasma product (such as hardware failures/malfunctions, software errors, disposable set equipment malfunctions, processing errors, automatic self-test/calibration errors, variations in hematocrit level in final product, variations in total volume of PRP concentrate produced, etc.)
Time Frame
Day 0 (Day of procedure)
Title
Number of suspected acute adverse reactions to the treatment
Description
Suspected adverse reactions to the treatment based on evaluations including follow-up physical examinations, labs and assessment of clinical signs and symptoms.
Time Frame
Day 0 to Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical and radiographic (MRI, CT or lumbar x-ray) evidence of symptomatic facet arthropathy involving the bilateral bottom two facets (e.g., L4-5 or L5-6 and L5-S1 or L6-S1).
Positive response, defined according to current clinical standards for the diagnosis of facet-mediated low back pain as greater than or equal to 75% pain improvement (as reported by patient) to diagnostic medial branch nerve blocks, one block with lidocaine and the other with bupivacaine.
Low back pain VAS score of greater than or equal to 5 at the clinical visit just prior to the first medial branch nerve block.
Exclusion Criteria:
Prior facet related procedure (intraarticular corticosteroid injection, radiofrequency ablation (RFA)) in last 6 months or prior fusion in the bottom two facets.
Current opioid use of greater than 50mg oral morphine milligram equivalents per day.
No advanced imaging (MRI, CT or lumbar x-ray) of the lumbar spine within the last 6 months.
BMI > 34.99 (WHO class I obesity).
Active systemic or local infection as evidenced by fever >100.4 degrees Fahrenheit, or any other clinical signs or symptoms of infection within 24 hours of the procedure.
On anticoagulation drug and has been on hold for less than 7 days prior to the investigational procedure.
Imaging evidence of high likelihood of failure for intra-articular injection in the opinion of the PI or delegate review of MRI, CT or lumbar x-ray imaging.
History of chronic thrombocytopenia (or pre-operative platelet count less than 195,000 per μl).
Undergoing chemotherapy at time of injection.
Pregnant or breastfeeding.
Use of illicit drugs within 30 days prior to study entry.
NSAID use during the pre-procedural period (one week before Treatment Day 0).
Preoperative hematocrit less than 36%.
History of hemodynamic instability or inability to maintain stable oncotic pressure.
History of prolonged clotting times.
Prior history of lumbar procedure.
Redness, swelling, rash or other concerning lesions at the injection site just prior to the procedure.
Prior history of allergy to lidocaine or other local anesthetic agent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Pingree, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Study Evaluating the Safety and Feasibility of Platelet-rich Plasma to Treat Facetogenic Low Back Pain
We'll reach out to this number within 24 hrs