OsteoarthritisPhase 1/2A2MRPNCT06329492
Autologous Alpha-2 Macroglobulin Rich Plasma, Safety and Efficacy in Symptomatic Moderate Knee Osteoarthritis
A Phase 1/2 study testing Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) in people with Osteoarthritis and OA, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness and safety of autologous alpha-2 macroglobulin rich plasma (A2MRP) injections in the treatment of knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, OA, Knee Osteoarthritis
- What is being tested?
- Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2024to 6 Feb 2026
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or females,18-65 years of age
- Chronic (> 3 months), unilaterally symptomatic, primary knee OA.
- Painful knee OA in one or more knee compartments grade 2-3 radiologic severity based upon the Kellgren-Lawrence grading scale, without evidence of advanced (bone on bone, as determined by study investigators) OA in the patellofemoral compartment or on Posterior Anterior (PA) flexion views
- Cognitive ability to give informed consent
- Speak fluent English
- Worst knee pain greater than 4 on a 0-10 pain scale (0 = no pain, 10 = worst pain imaginable)
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- Previous 6 week or longer trial of one of the following conservative treatments: activity modification, weight loss, physical therapy, anti-inflammatory medications/acetaminophen or injection therapy (e.g., cortisone)
- Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including blood draw, laboratory tests, diagnostic imaging, and follow-up visits and assessments
- Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure.
Who cannot join
- Pregnant or nursing, or planning on becoming pregnant during the study period
- Congenital or acquired malformation of the target knee resulting in significant deformity or leading to problems with the study treatment or analysis of the results
- Significant valgus or varus malalignment as determined by investigator
- Injections of any kind into the target knee:
- Corticosteroid injections within 3 months prior to study enrollment
- Hyaluronic acid injections within 6 months prior to study enrollment
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- PRP injection within the year prior to study enrollment
- History of BMAC, Micro-Fragmented Adipose Tissue (MFAT), or perinatal product injection at any point
- History of intra-articular infection in the target knee
- History of superficial infection in the target knee within 6 months of study enrollment, or evidence of current superficial infection affecting the target knee
- Body mass index (BMI) < 35 kg/m2
- Inability to stop non-steroidal anti-inflammatory medications for 1 week before through 2 weeks after the procedure date
- On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids
- Current tobacco product use, including nicotine patch or other nicotine products
- Clinically significant rheumatological or inflammatory disease or chondrocalcinosis/ calcium pyrophosphate disease (CPPD), hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, systemic sclerosis, system lupus erythematosus, and Ehlers-Danlos Syndrome, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis
- Surgery in the target knee within the last 12 months, or planned surgery in the target knee in next 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP), Safety and Efficacy in Symptomatic Moderate Knee Osteoarthritis: A Pilot Study
The purpose of this study is to determine the effectiveness and safety of autologous alpha-2 macroglobulin rich plasma (A2MRP) injections in the treatment of knee osteoarthritis (OA).
Read the detailed description
The overall objective of this study is to test and quantify A2MRP and prepare for a larger randomized clinical trial assessing the efficacy of A2MRP injections in primary and post traumatic knee osteoarthritis (OA) with respect to clinical outcomes and disease progression. The study will also assess safety of A2MRP intraarticular injection in patients with symptomatic knee OA. Patients with symptomatic mild to moderate knee OA (KL 2-3) will be candidates for this study. Baseline data will include physical examination of the knee, clinical assessment of knee pain and function using validated patient reported outcome measures (PROMs), and radiologic exam of the knee will be obtained. All injections will be performed using ultrasound guidance and all patients will followed-up at week 1 week post-injection for acute adverse events (AEs). Each subject will be clinically followed-up for study endpoints using a predetermined protocol. PROs will be collected during the study period pre-procedure, and at 1, 2, and 6 weeks, 3-, 6-, 9- and 12-months post-procedure (Specific PRO's and timepoints noted in sections 6.2-6.7). Subjects will also be asked questions regarding satisfaction with the treatment and whether they would recommend the treatment
- Conditions
- Osteoarthritis, OA, Knee Osteoarthritis
- Being tested
- Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP)
- Keywords
- regenerative med
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP)Biological
Your blood will be processed into Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) A2MRP in the procedure room with you while you wait. This will take approximately 30 minutes. When this is complete, an ultrasound will be done of your knee to determine the best location for injection into the knee joint. You will undergo an ultrasound guided injection, and the needle guided into the knee joint, and the Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) A2MRP will be injected into the joint space. If there is excessive fluid in your knee, this may be drained before the injection is performed. The needle will be removed, and a band aid will be placed over the injection site.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) | Experimental | Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) is produced by filtering Platelet Poor Plasma (PPP), a Platelet Rich Plasma byproduct, through a hemoconcentrator filter. (PPP) is frequently used in clinical practice to increase volume of PRP or Bone Marror Aspirate Concentrate (BMAC) injectate, and it is occasionally injected in isolation for some indication Receives: Biological: Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
The number of Adverse Events reported
Measured: 1 year
Secondary outcomes (5)
Visual Analog Scale (VAS) for Pain
The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.
Measured: 1 year
Patient-Reported Outcomes Measurement Information System (PROMIS)-Computer adaptive test (CAT): Pain interference
The PROMIS-CAT: Pain interference is a 40-item questionnaire assessing pain. Using a scale of 1 = not at all to 5 = very much. Total scores range from 40-200, lower scores indicating lower pain and higher scores indicating greater pain.
Measured: 1 year
Patient-Reported Outcomes Measurement Information System (PROMIS)-Computer adaptive test (CAT): Physical function
The PROMIS-CAT: Physical function is a 165-item questionnaire assessing physical function. Using a scale of 1 = unable to do to 5 = without any difficulty. Total scores range from 165-825, lower scores indicating less physical function and higher scores indicating greater physical function.
Measured: 1 year
Knee Injury and Osteoarthritis Outcome Score (KOOS):
KOOS is a commonly used questionnaire which focuses on how patients are affected by knee problems in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme knee problems, 100 = no knee problems
Measured: 1 year
Procedure Recommendation
The number of subjects to answer "yes" to the question "Would you recommend this procedure to someone with a similar condition as your own?"
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start9 Jan 2024
- Primary completion28 Jan 2026
- Study completion6 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group cohort of 20 subjects
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brennan J. Boettcher, Mayo Clinic
- Investigators
- Brennan Boettcher, D.O, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329492
- Sponsor's protocol ID
- 23-007937
- Acronym
- A2MRP
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP), Safety and Efficacy in Symptomatic Moderate Knee Osteoarthritis: A Pilot Study
- ClinicalTrials.gov ID
- NCT06329492
- Acronym / sponsor ID
- A2MRP / 23-007937
- Conditions
- Osteoarthritis, OA, Knee Osteoarthritis
- Keywords
- regenerative med
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 26 Mar 2024 (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.
The purpose of this study is to determine the effectiveness and safety of autologous alpha-2 macroglobulin rich plasma (A2MRP) injections in the treatment of knee osteoarthritis (OA).
Detailed description
The overall objective of this study is to test and quantify A2MRP and prepare for a larger randomized clinical trial assessing the efficacy of A2MRP injections in primary and post traumatic knee osteoarthritis (OA) with respect to clinical outcomes and disease progression. The study will also assess safety of A2MRP intraarticular injection in patients with symptomatic knee OA. Patients with symptomatic mild to moderate knee OA (KL 2-3) will be candidates for this study. Baseline data will include physical examination of the knee, clinical assessment of knee pain and function using validated patient reported outcome measures (PROMs), and radiologic exam of the knee will be obtained. All injections will be performed using ultrasound guidance and all patients will followed-up at week 1 week post-injection for acute adverse events (AEs). Each subject will be clinically followed-up for study endpoints using a predetermined protocol. PROs will be collected during the study period pre-procedure, and at 1, 2, and 6 weeks, 3-, 6-, 9- and 12-months post-procedure (Specific PRO's and timepoints noted in sections 6.2-6.7). Subjects will also be asked questions regarding satisfaction with the treatment and whether they would recommend the treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group cohort of 20 subjects
| Arm | Type | Receives |
|---|---|---|
| Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) | Experimental | Biological: Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP)Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) is produced by filtering Platelet Poor Plasma (PPP), a Platelet Rich Plasma byproduct, through a hemoconcentrator filter. (PPP) is frequently used in clinical practice to increase volume of PRP or Bone Marror Aspirate Concentrate (BMAC) injectate, and it is occasionally injected in isolation for some indication |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or females,18-65 years of age
- Chronic (> 3 months), unilaterally symptomatic, primary knee OA.
- Painful knee OA in one or more knee compartments grade 2-3 radiologic severity based upon the Kellgren-Lawrence grading scale, without evidence of advanced (bone on bone, as determined by study investigators) OA in the patellofemoral compartment or on Posterior Anterior (PA) flexion views
- Cognitive ability to give informed consent
- Speak fluent English
Key exclusion criteria (16 listed)
- Pregnant or nursing, or planning on becoming pregnant during the study period
- Congenital or acquired malformation of the target knee resulting in significant deformity or leading to problems with the study treatment or analysis of the results
- Significant valgus or varus malalignment as determined by investigator
- Injections of any kind into the target knee:
- History of intra-articular infection in the target knee
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 |
|---|---|---|
| Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP)Your blood will be processed into Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) A2MRP in the procedure room with you while you wait. This will take approximately 30 minutes. When this is complete, an ultrasound will be done of your knee to determine the best location for injection into the knee joint. You will undergo an ultrasound guided injection, and the needle guided into the knee joint, and the Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) A2MRP will be injected into the joint space. If there is excessive fluid in your knee, this may be drained before the injection is performed. The needle will be removed, and a band aid will be placed over the injection site. | Biological | Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) |
Primary outcome
Adverse Events
Time frame: 1 year
The number of Adverse Events reported
5 secondary outcomes
Visual Analog Scale (VAS) for Pain
Time frame: 1 year
Patient-Reported Outcomes Measurement Information System (PROMIS)-Computer adaptive test (CAT): Pain interference
Time frame: 1 year
Patient-Reported Outcomes Measurement Information System (PROMIS)-Computer adaptive test (CAT): Physical function
Time frame: 1 year
Knee Injury and Osteoarthritis Outcome Score (KOOS):
Time frame: 1 year
Procedure Recommendation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
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Holistic Healing for Knee Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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.
Brennan Boettcher, D.O 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 1/2 study testing Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) in people with Osteoarthritis and OA, run by Mayo Clinic 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 9 inclusion and 16 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: finished, as of the sponsor's last update on 12 Feb 2026. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse Events (time frame: 1 year). 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 12 Feb 2026.