ACP Max™ for Knee Osteoarthritis

Recruiting at 2 trial locations

Overseen By Mark Hermann, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arthrex, Inc.

Must not be taking: Corticosteroids, HA, PRP, others

Disqualifiers: Rheumatoid arthritis, Gout, Inflammatory diseases, others

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

Compensation: Varies

Number of Visits: 8

Duration: 1 day

45 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

Participants must stop taking NSAIDs and analgesics 7 days before each study visit, except for low-dose aspirin used for heart disease prevention.

What data supports the effectiveness of the treatment ACP Max™ for knee osteoarthritis?

Research shows that autologous conditioned plasma (ACP) and platelet-rich plasma (PRP) have promising results in treating knee osteoarthritis, with some studies indicating they may be as effective as other therapies. Additionally, methylprednisolone acetate injections have been shown to benefit knee osteoarthritis symptoms. ^{1 2 3 4 5}

Is ACP Max™ safe for treating knee osteoarthritis?

Research on Autologous Conditioned Plasma (ACP), a form of platelet-rich plasma, suggests it is generally safe for use in humans, as no significant safety concerns were reported in studies involving knee osteoarthritis patients. ^{1 2 6 7 8}

How is the treatment ACP Max™ for knee osteoarthritis different from other treatments?

ACP Max™ is unique because it uses autologous conditioned plasma (ACP), a type of platelet-rich plasma (PRP) that contains high concentrations of growth factors from the patient's own blood, which may help reduce symptoms of knee osteoarthritis by improving lubrication in the joint. ^{1 2 6 9 10}

What is the purpose of this trial?

This study is a prospective, multicenter (up to 4 sites), randomized, double-blind, two-arm study. Forty-five (45) patients will be randomized to receive a single 4-6 ml intra-articular (IA) injection of either the output of ACP Max™ (n=30) or 6 ml of Depo-Medrol® (methylprednisolone acetate) (n=15).

Eligibility Criteria

This trial is for adults aged 18 to 75 with knee osteoarthritis who've tried oral meds or anti-inflammatories for at least 6 months without relief. They need X-rays showing certain levels of joint damage and significant pain despite treatment. Participants must not be overweight (BMI ≤ 35) and agree to stop taking NSAIDs a week before visits.

Inclusion Criteria

My knee X-ray shows moderate to severe arthritis.

My knee pain is severe and it's hard for me to do daily activities.

I agree to stop taking painkillers 7 days before each study visit, except for low-dose aspirin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive a single 4-6 ml intra-articular injection of either ACP Max™ or Depo-Medrol®

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

6 visits (in-person) at 10 days, 6 weeks, 3, 6, 9, and 12 months

Treatment Details

Interventions

• ACP Max™
• Depo-Medrol®

Trial Overview The study tests the ACP Max™ PRP System against Depo-Medrol® injections in people with knee osteoarthritis. It's a controlled test where patients are randomly chosen to receive one of these treatments, but neither they nor the doctors know which one until after the results are collected.

Participant Groups

Group I: ACP Max™ Experimental Treatment 1 Intervention

Single 4-6 ml intra-articular (IA) injection of the output of ACP Max™

Group II: 40 mg of methylprednisolone acetate Active Control 1 Intervention

Single IA injection of 40 mg of methylprednisolone acetate (1 ml of solution) mixed with 5 ml of Normal Saline for a total of 6 ml.

ACP Max™ is already approved in United States for the following indications:

Approved in United States as ACP Max™ for:

• Knee Osteoarthritis

Who Is Running the Clinical Trial?

Arthrex, Inc.

Lead Sponsor

Trials

48

Recruited

30,200+

Findings from Research

In a study of 260 patients with knee osteoarthritis, treatment with autologous conditioned plasma (ACP) showed a statistically significant improvement in knee function over 12 months, but only 40% of patients achieved a meaningful improvement after 6 months, indicating limited overall benefit.

Older patients experienced better outcomes from ACP treatment, while those receiving bilateral injections had worse results, suggesting that patient factors can influence the effectiveness of ACP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Autologous Conditioned Plasma Injections in Patients With Knee Osteoarthritis. Korpershoek, JV., Vonk, LA., Filardo, G., et al.[2023]

In a randomized controlled trial involving 90 participants with knee osteoarthritis, both autologous platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMC) showed significant improvements in pain and function over 24 months, with no significant differences between the two treatments.

Both PRP and BMC led to sustained improvements in patient-reported outcomes, plateauing at 3 months and maintained through 24 months, indicating that neither treatment was superior to the other for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone Marrow Aspirate Concentrate Is Equivalent to Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis at 2 Years: A Prospective Randomized Trial. Anz, AW., Plummer, HA., Cohen, A., et al.[2022]

Intra-articular platelet-rich plasma (IA-PRP) injections significantly improve patient outcomes for knee osteoarthritis, with benefits starting as early as 2 months and lasting up to 12 months after treatment, based on a systematic review of three high-quality meta-analyses.

Patients with less severe arthritis showed greater improvement from PRP treatment, but there is a potential risk of local adverse reactions with multiple injections, suggesting careful consideration in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Intra-articular Platelet-Rich Plasma Injection Provide Clinically Superior Outcomes Compared With Other Therapies in the Treatment of Knee Osteoarthritis? A Systematic Review of Overlapping Meta-analyses. Campbell, KA., Saltzman, BM., Mascarenhas, R., et al.[2022]

In a study of 65 patients with early knee osteoarthritis, treatment with leukocyte-poor platelet-rich plasma (LP-PRP) injections resulted in significantly greater pain reduction and improved knee function compared to acetaminophen over a 24-week period.

LP-PRP therapy not only provided sustained improvements in pain and quality of life but also may help modify the inflammatory environment in the joint by counteracting the effects of IL-1β, a key player in osteoarthritis progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leukocyte-poor platelet-rich plasma is more effective than the conventional therapy with acetaminophen for the treatment of early knee osteoarthritis. Simental-Mendía, M., Vílchez-Cavazos, JF., Peña-Martínez, VM., et al.[2022]

A 40 mg intra-articular injection of methylprednisolone acetate (MPA) can provide clinical benefits for knee osteoarthritis symptoms, but careful consideration of factors like pain severity and individual patient circumstances is crucial for effectiveness.

There are significant safety concerns and contraindications associated with MPA injections, especially regarding patients on anticoagulants, highlighting the need for individualized treatment plans and thorough risk-benefit evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Review of Methylprednisolone Acetate Intra-Articular Injection in the Management of Osteoarthritis of the Knee - Part 2: Clinical and Procedural Considerations. McCrum, C.[2018]

In a study of 140 patients with knee osteoarthritis receiving three injections of Autologous Conditioned Plasma (ACP), there was only a modest improvement in knee function (KOOS score increased from 37 to 45 at 6 months) and pain reduction (NRS decreased from 6.2 to 5.2 at 6 months), which did not reach clinically significant levels.

The study found no patient factors, such as age, sex, or BMI, that could predict the clinical outcomes, suggesting that ACP may not be a reliable treatment option for improving symptoms in knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular injection with Autologous Conditioned Plasma does not lead to a clinically relevant improvement of knee osteoarthritis: a prospective case series of 140 patients with 1-year follow-up. Korpershoek, JV., Vonk, LA., De Windt, TS., et al.[2023]

Autologous Protein Solution (APS) is a promising treatment for knee osteoarthritis (OA) that contains high levels of growth factors and anti-inflammatory mediators, potentially aiding in pain relief and joint function.

Preliminary studies suggest that APS may have regenerative properties and a favorable safety profile, but further clinical research is needed to fully understand its effectiveness and benefits in treating OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative regenerative medicine in the management of knee OA: The role of Autologous Protein Solution. Vitale, ND., Vandenbulcke, F., Chisari, E., et al.[2020]

In a study involving 30 patients with knee osteoarthritis who did not respond to standard treatments and PRP injections, autologous conditioned serum (ACS) showed significant efficacy in pain relief and functional improvement, with 67% of patients reporting benefits within one month that lasted up to 12 months.

The effectiveness of ACS was associated with higher levels of interleukin-1 receptor antagonist (IL1-RA) in the serum, suggesting that this component may play a key role in the treatment's mechanism of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain control and functional improvement in patients treated by autologous conditioned serum after failure of platelet rich plasma treatments in knee osteoarthritis. Leone, R., de Rosa, A., Iudicone, P., et al.[2022]

Platelet-rich plasma (PRP) significantly stimulates the proliferation of cells from human knee joint tissues and enhances the secretion of superficial zone protein (SZP), which is crucial for cartilage lubrication.

PRP demonstrates effective lubricating properties on bovine articular cartilage, reducing friction to levels comparable to synovial fluid, which supports its potential efficacy in treating osteoarthritis in the knee.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulation of the superficial zone protein and lubrication in the articular cartilage by human platelet-rich plasma. Sakata, R., McNary, SM., Miyatake, K., et al.[2022]

The study compared autologous conditioned plasma (ACP) prepared using a commercial kit with ACP made using hospital equipment, finding that both methods produced similar platelet concentrations, indicating that effective ACP can be generated without relying on commercial systems.

The proprietary ACP preparation showed comparable platelet density to the commercial kit, suggesting that hospitals can produce high-quality ACP efficiently and safely using their own sterile equipment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison Analysis of Autologous Conditioned Plasma. Lebiedziński, R., Borowski, A., Synder, M., et al.[2017]

References

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

Effect of Autologous Conditioned Plasma Injections in Patients With Knee Osteoarthritis. [2023]

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

Bone Marrow Aspirate Concentrate Is Equivalent to Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis at 2 Years: A Prospective Randomized Trial. [2022]

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

Does Intra-articular Platelet-Rich Plasma Injection Provide Clinically Superior Outcomes Compared With Other Therapies in the Treatment of Knee Osteoarthritis? A Systematic Review of Overlapping Meta-analyses. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Leukocyte-poor platelet-rich plasma is more effective than the conventional therapy with acetaminophen for the treatment of early knee osteoarthritis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Therapeutic Review of Methylprednisolone Acetate Intra-Articular Injection in the Management of Osteoarthritis of the Knee - Part 2: Clinical and Procedural Considerations. [2018]

6. Sweden pubmed.ncbi.nlm.nih.gov

Intra-articular injection with Autologous Conditioned Plasma does not lead to a clinically relevant improvement of knee osteoarthritis: a prospective case series of 140 patients with 1-year follow-up. [2023]

7. India pubmed.ncbi.nlm.nih.gov

Innovative regenerative medicine in the management of knee OA: The role of Autologous Protein Solution. [2020]

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

Pain control and functional improvement in patients treated by autologous conditioned serum after failure of platelet rich plasma treatments in knee osteoarthritis. [2022]

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

Stimulation of the superficial zone protein and lubrication in the articular cartilage by human platelet-rich plasma. [2022]

10. Poland pubmed.ncbi.nlm.nih.gov

Comparison Analysis of Autologous Conditioned Plasma. [2017]