ACP Max™ for Knee Osteoarthritis

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments to determine which more effectively eases knee pain from osteoarthritis. One group receives an injection of ACP Max™ (a form of platelet-rich plasma), while the other receives an injection of the common steroid Depo-Medrol®. The goal is to identify which treatment better reduces pain and improves knee function. The trial seeks participants who have experienced knee osteoarthritis symptoms for at least six months and have not found sufficient relief from medications or other treatments. As an unphased trial, it offers a unique opportunity to explore new treatment options for knee osteoarthritis.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ACP Max™ is safe for treating knee osteoarthritis. Studies have found that this treatment, which uses Autologous Conditioned Plasma (ACP), is well-tolerated by patients. Notably, these studies reported no negative reactions. Patients experienced pain relief and improved knee movement.

Depo-Medrol® (methylprednisolone acetate) is commonly used to reduce inflammation and is generally considered safe. However, like any medication, some people may experience side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for knee osteoarthritis, which often involve oral pain medications or physical therapy, ACP Max™ is unique because it uses a single intra-articular injection derived from the patient's own blood plasma. This approach targets inflammation and promotes healing directly within the knee joint. Researchers are excited about ACP Max™ because it offers a more natural and potentially safer alternative to steroids or hyaluronic acid injections, with the added benefit of possibly providing longer-lasting relief from symptoms.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Research has shown that Autologous Conditioned Plasma (ACP), which participants in this trial may receive as ACP Max™, might help with knee osteoarthritis. In some studies, patients reported less pain and improved knee movement for up to a year after receiving ACP injections. However, not all research agrees, and some studies suggest the benefits might be limited. This treatment uses a person's own blood plasma, rich in platelets that aid healing, making it a promising alternative to traditional treatments. Another option in this trial is a single injection of methylprednisolone acetate, serving as an active comparator. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10879647/

Autologous Conditioned Plasma (ACP) and Osteoarthritis of ... Statistically significant improvements in the IKDC and VAS scores were observed at 24 and 52 weeks follow-up compared to the baseline. However, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10387782/

Effect of Autologous Conditioned Plasma Injections in ... The study findings show the limited benefit of ACP treatment for knee OA and call for caution with routine use in clinical practice.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0749806324002068

A Greater Platelet Dose May Yield Better Clinical ... The purpose of this study was to determine whether the platelet dose administered during a PRP injection for knee OA affects clinical outcomes.

4. aaos.org aaos.org/globalassets/quality-and-practice-resources/biologics/technology-overview_prp-for-knee-oa.pdf

Platelet-Rich Plasma (PRP) for Knee Osteoarthritis ... Platelet Rich Plasma (Autologous Conditioned. Plasma, ACP): mean injection 5mL; x1/week x 4 weeks. Hyaluronic Acid treatment: 20mg/2mL; x1/week x4 weeks. Mean ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/19476035251323376?int.sj-full-text.similar-articles.9

Clinical and Cellular Predictors of Outcomes in Autologous ... Autologous conditioned plasma provided clinical benefits in this cohort study of knee OA patients for at least 6 months post-injection. Older ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02713542

Autologous Conditioned Plasma (ACP) Intra-articular (IA) ... This study is primarily investigating the effectiveness of Autologous Conditioned Plasma (ACP) Intra-articular (IA) in patients with Osteoarthritis (OA) in the ...

7. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/0363546515624678

Intra-articular Autologous Conditioned Plasma Injections ... ACP is safe and provides quantifiable benefits for pain relief and functional improvement with regard to knee OA. No adverse events were reported for ACP ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2667254523000343

Original Research Platelet-rich plasma is similar to ... Intra-articular autologous conditioned plasma injections provide safe and efficacious treatment for knee osteoarthritis: an FDA-sanctioned, randomized ...