Lumbar SpondylosisPhase 1NCT05250947
Study Evaluating the Safety and Feasibility of Platelet-rich Plasma to Treat Facetogenic Low Back Pain
A Phase 1 study testing Angel® Concentrated Platelet Rich Plasma System and Platelet Rich Plasma in people with Lumbar Spondylosis, run by Matthew Pingree at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Lumbar Spondylosis
- What is being tested?
- Angel® Concentrated Platelet Rich Plasma System and Platelet Rich Plasma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2023to 20 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Phase I Study Evaluating the Safety and Feasibility of Platelet-rich Plasma for the Treatment of Facetogenic Low Back Pain
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).
Read the 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.
- Conditions
- Lumbar Spondylosis
- Being tested
- Angel® Concentrated Platelet Rich Plasma System, Platelet Rich Plasma
- Keywords
- arthritis, facet joint, lumbar spondylosis, back pain
- Medical subject headings
- Spondylosis, Arthritis, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angel® Concentrated Platelet Rich Plasma SystemDevice
Angel® Concentrated Platelet Rich Plasma System and Angel® cPRP Processing Set will be used to process the PRP.
Platelet Rich PlasmaDrug
6 ml will be injected in up to 4 facet joints (2 levels) at 1.5 ml per joint
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Angel® Concentrated Platelet Rich Plasma System; Drug: Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.
Measured: Day 0 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start5 Jan 2023
- Primary completion20 May 2024
- Study completion20 May 2024
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar SpondylosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot safety study.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Pingree
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthew Pingree, Mayo Clinic
- Investigators
- Matthew Pingree, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250947
- Sponsor's protocol ID
- 18-011475
- Status last verified
- Jul 2024
- First submitted
- 4 Jan 2022
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Evaluating the Safety and Feasibility of Platelet-rich Plasma for the Treatment of Facetogenic Low Back Pain
- ClinicalTrials.gov ID
- NCT05250947
- Acronym / sponsor ID
- 18-011475
- Conditions
- Lumbar Spondylosis
- Keywords
- arthritis, facet joint, lumbar spondylosis, back pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Matthew PingreeUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot safety study.
| Arm | Type | Receives |
|---|---|---|
| PRP Injection Arm | Experimental | Device: Angel® Concentrated Platelet Rich Plasma System, Drug: Platelet Rich PlasmaThe 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. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angel® Concentrated Platelet Rich Plasma SystemAngel® Concentrated Platelet Rich Plasma System and Angel® cPRP Processing Set will be used to process the PRP. | Device | PRP Injection Arm |
| Platelet Rich Plasma6 ml will be injected in up to 4 facet joints (2 levels) at 1.5 ml per joint | Drug | PRP Injection Arm |
Primary outcome
Number of adverse device effects
Time frame: Day 0 (Day of procedure)
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
Time frame: Day 0 to Day 14
Suspected adverse reactions to the treatment based on evaluations including follow-up physical examinations, labs and assessment of clinical signs and symptoms.
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Pingree, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Angel® Concentrated Platelet Rich Plasma System and Platelet Rich Plasma in people with Lumbar Spondylosis, run by Matthew Pingree at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse device effects (time frame: Day 0 (Day of procedure)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.