Plasma Injections for Knee Osteoarthritis

(A2MRP Trial)

Overseen By Erin Hennessey

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Mayo Clinic

Must not be taking: Corticosteroids, Hyaluronic acid, PRP

Disqualifiers: Pregnancy, Knee deformity, Infections, BMI < 35, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial requires participants to stop taking non-steroidal anti-inflammatory medications for 1 week before and 2 weeks after the procedure. If you are on chronic immunosuppressive therapy or systemic steroids, you may not be eligible to participate.

What data supports the effectiveness of the treatment Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) for knee osteoarthritis?

Research suggests that alpha-2-macroglobulin, a component of A2MRP, has anti-inflammatory properties that may help reduce knee pain in osteoarthritis. Additionally, platelet-rich plasma (PRP), which is similar to A2MRP, has been shown to improve pain and function in knee osteoarthritis, especially when combined with other treatments like hyaluronic acid. ^{1 2 3 4 5}

Is plasma injection treatment safe for humans?

Research on platelet-rich plasma (PRP) injections, which are similar to plasma injections, shows they are generally safe for treating osteoarthritis in joints like the ankle and knee. No major safety concerns have been reported in these studies. ^{2 4 5 6 7}

How is the treatment Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) different from other treatments for knee osteoarthritis?

Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) is unique because it uses a component called alpha-2-macroglobulin, which has anti-inflammatory properties, potentially offering a novel way to reduce knee pain in osteoarthritis compared to traditional treatments. This treatment is derived from the patient's own blood, making it a personalized therapy. ^{1 2 8 9 10}

Research Team

Brennan Boettcher, D.O

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults aged 18-65 with moderate knee osteoarthritis, experiencing pain greater than 4 on a scale of 0-10. Participants must have tried conservative treatments for over six weeks and be fluent in English. Excluded are pregnant individuals, those with recent infections or surgeries in the target knee, BMI over 35, significant knee deformity or alignment issues, chronic immunosuppression, or current tobacco/nicotine use.

Inclusion Criteria

My worst knee pain is more than 4 out of 10.

I have moderate knee pain from arthritis without severe damage in certain knee areas.

Speak fluent English

Exclusion Criteria

Pregnant or nursing, or planning on becoming pregnant during the study period

My knee had an infection or currently has one.

I have a significant inflammatory or rheumatological condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive autologous alpha-2 macroglobulin rich plasma (A2MRP) injections for knee osteoarthritis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 2, and 6 weeks, and 3, 6, 9, and 12 months post-procedure

12 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP)

Trial Overview The study tests the safety and effectiveness of A2MRP injections directly into the knee to treat symptoms of osteoarthritis. It aims to see if this treatment can reduce pain and improve joint function compared to standard therapies.

Participant Groups

Group I: Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Role of Alpha-2-Microglobulin in the Treatment of Osteoarthritic Knee Pain: a Brief Review of the Literature. [2020]

2. India pubmed.ncbi.nlm.nih.gov

Efficacy of different platelet-rich plasma injections in the treatment of mild-moderate knee osteoarthritis: A systematic review and meta-analysis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma Combined With Hyaluronic Acid Improves Pain and Function Compared With Hyaluronic Acid Alone in Knee Osteoarthritis: A Systematic Review and Meta-analysis. [2021]

4. Turkey pubmed.ncbi.nlm.nih.gov

Single versus multi-dose intra-articular injection of platelet rich plasma in early stages of osteoarthritis of the knee: A single-blind, randomized, superiority trial. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Intra-Articular Injection of Platelet-Rich Plasma on the Serum Levels of Osteoarthritic Biomarkers in Patients with Unilateral Knee Osteoarthritis. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Safety and efficacy of intra-articular injection of platelet-rich plasma for the treatment of ankle osteoarthritis: a systematic review and meta-analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The anti-inflammatory and matrix restorative mechanisms of platelet-rich plasma in osteoarthritis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Effect of microfracture and autologous-conditioned plasma application in the focal full-thickness chondral defect of the knee: an experimental study on rabbits. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Effect of Leukocyte Concentration on the Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Clinical results of autologous protein solution injection for knee osteoarthritis with severe disease grade is inferior to mild or moderate grade. [2023]