45 Participants Needed

ACP Max™ for Knee Osteoarthritis

Recruiting at 2 trial locations
TM
MH
TM
MH
MH
Overseen ByMark Hermann, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12678

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.126910

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.
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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
2Treatment groups
Experimental Treatment
Active Control
Group I: ACP Max™Experimental Treatment1 Intervention
Single 4-6 ml intra-articular (IA) injection of the output of ACP Max™
Group II: 40 mg of methylprednisolone acetateActive Control1 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

Find a Clinic Near You

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.
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.
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.
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]

References

Effect of Autologous Conditioned Plasma Injections in Patients With Knee Osteoarthritis. [2023]
Bone Marrow Aspirate Concentrate Is Equivalent to Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis at 2 Years: A Prospective Randomized Trial. [2022]
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]
Leukocyte-poor platelet-rich plasma is more effective than the conventional therapy with acetaminophen for the treatment of early knee osteoarthritis. [2022]
Therapeutic Review of Methylprednisolone Acetate Intra-Articular Injection in the Management of Osteoarthritis of the Knee - Part 2: Clinical and Procedural Considerations. [2018]
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]
Innovative regenerative medicine in the management of knee OA: The role of Autologous Protein Solution. [2020]
Pain control and functional improvement in patients treated by autologous conditioned serum after failure of platelet rich plasma treatments in knee osteoarthritis. [2022]
Stimulation of the superficial zone protein and lubrication in the articular cartilage by human platelet-rich plasma. [2022]
Comparison Analysis of Autologous Conditioned Plasma. [2017]
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