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Projected cost to continue was not supported by the study budget and additional funds could not be obtained so the decision to close the study was made.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP Injection Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angel® Concentrated Platelet Rich Plasma System | Device | Angel® Concentrated Platelet Rich Plasma System and Angel® cPRP Processing Set will be used to process the PRP. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | Day 0 (Day of procedure) |
| 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. | Day 0 to Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Pingree, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D055009 | Spondylosis |
| D001168 | Arthritis |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
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This is a pilot safety study.
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| Platelet Rich Plasma | Drug | 6 ml will be injected in up to 4 facet joints (2 levels) at 1.5 ml per joint |
|
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |