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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether injections of a special blood product, autologous alpha-2 macroglobulin rich plasma (A2MRP), can help individuals with knee osteoarthritis (OA). The aim is to determine if these injections can safely reduce pain and improve knee function. Suitable candidates have experienced knee OA for over three months, suffer significant knee pain, and have tried other treatments like physical therapy or pain medications without sufficient relief. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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.

Is there any evidence suggesting that autologous alpha-2 macroglobulin rich plasma (A2MRP) injections are likely to be safe for humans?

Research has shown that injections of a special type of plasma, called A2MRP, are usually well-tolerated. Studies in animals with knee osteoarthritis have found that this treatment can help restore joint health and prevent cartilage damage. When similar plasma treatments were tested in humans, they significantly improved knee pain and function over several months, with few complications. These findings suggest that A2MRP might be safe for humans as well. However, since the study is in its early stages, it primarily focuses on safety. While there isn't much human data yet, early results are promising. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) for knee osteoarthritis because it offers a novel approach compared to standard treatments like NSAIDs, corticosteroids, and hyaluronic acid injections. Unlike these traditional therapies that primarily aim to reduce symptoms, A2MRP is derived from the patient's own blood, specifically targeting and neutralizing inflammatory molecules with alpha-2 macroglobulin. This personalized treatment could potentially provide a more natural and sustained relief by addressing the root cause of inflammation in the joint, promising longer-lasting and possibly more effective outcomes.

What evidence suggests that autologous alpha-2 macroglobulin rich plasma (A2MRP) injections might be an effective treatment for knee osteoarthritis?

Research has shown that injections of a special part of your own blood, called autologous alpha-2 macroglobulin rich plasma (A2MRP), might help relieve knee pain from osteoarthritis. In earlier studies, participants noticed some improvement in knee pain and movement within six weeks after receiving the treatment. This involves using a part of blood plasma that may help reduce swelling and pain. Some doctors report that A2MRP can quickly ease pain. Although these results are encouraging, they have been mixed, and more research is needed to confirm its effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

Brennan Boettcher, D.O

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06329492

NCT06329492 | Autologous Alpha-2 Macroglobulin Rich ... 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 ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20561314

Autologous Alpha-2 Macroglobulin Rich Plasma, Safety ... The purpose of this study is to determine the effectiveness and safety of autologous alpha-2 macroglobulin rich plasma (A2MRP) injections in the ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39259950/

The Effectiveness of Alpha-2-Macroglobulin Injections for ... Alpha-2-macroglobulin treatment resulted in modest improvement in knee pain and function at 6-week follow-up, albeit inconsistently across PRO measures and to a ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S266725452500023X

Preparation of alpha-2 macroglobulin–rich plasma from ... Physicians utilizing A2MRP in their clinical practice purport relatively rapid pain relief, which is unique among orthobiologic injections for ...

5. members.aana.org members.aana.org/aanaimis/SiteDownloads/Education/AnnualMeeting/20-eposters/91-thompson.pdf

The Effectiveness of Alpha-2-Macroglobulin Injections for ... Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee. Osteoarthritis: An FDA-Sanctioned, Randomized, Double- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8836227/

Intra-Articular Platelet-Rich Plasma Injections in Knee ... PRP total knee scores were significantly better than baseline at 1, 2, 3, 6, and 12 months following PRP injection. Regarding complications, PRP did not ...