ACP Max™ for Knee Osteoarthritis
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Arthrex, Inc.
Must not be taking: Corticosteroids, HA, PRP, others
Disqualifiers: Rheumatoid arthritis, Gout, Inflammatory diseases, others
No Placebo Group
Trial Summary
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).
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.
12345Is 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.
12678How 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.
126910Eligibility 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.
+4 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
AMR KnoxvilleKnoxville, TN
Spectrum Medical, Inc.Danville, VA
The Center for Clinical ResearchWinston-Salem, NC
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Who Is Running the Clinical Trial?
Arthrex, Inc.Lead Sponsor
References
Effect of Autologous Conditioned Plasma Injections in Patients With Knee Osteoarthritis. [2023]Autologous conditioned plasma (ACP) is a commercially available platelet concentrate with promising results from clinical trials.
Bone Marrow Aspirate Concentrate Is Equivalent to Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis at 2 Years: A Prospective Randomized Trial. [2022]Autologous platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMC) are being used clinically as therapeutic agents for the treatment of knee osteoarthritis.
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]The aims of this study were (1) to perform a systematic review of meta-analyses evaluating platelet-rich plasma (PRP) injection in the treatment of knee joint cartilage degenerative pathology, (2) to provide a framework for analysis and interpretation of the best available evidence to provide recommendations for use (or lack thereof) of PRP in the setting of knee osteoarthritis (OA), and (3) to identify literature gaps where continued investigation would be suggested.
Leukocyte-poor platelet-rich plasma is more effective than the conventional therapy with acetaminophen for the treatment of early knee osteoarthritis. [2022]Knee osteoarthritis (OA) is a degenerative and progressive articular cartilage disease. Infiltration of autologous platelet-rich plasma (PRP) has been proposed as a therapeutic alternative due to the content of biologically active cytokines in PRP. We aimed to compare the clinical response of acetaminophen and intra-articular leukocyte-poor PRP (LP-PRP) in early knee OA.
Therapeutic Review of Methylprednisolone Acetate Intra-Articular Injection in the Management of Osteoarthritis of the Knee - Part 2: Clinical and Procedural Considerations. [2018]The use of an intra-articular methylprednisolone acetate (MPA) injection has been shown to have benefits for symptoms of knee osteoarthritis (OA). However, considerations beyond drug efficacy can influence the appropriateness, clinical effectiveness and potential harm of an injection. A review of research evidence and published literature on clinical and procedural factors influencing the effectiveness and safety of a knee injection has been undertaken. Factors include dose, frequency, contraindications, precautions, drug interactions, side-effects, and procedural and patient-related considerations. An evaluation of evidence indicated that a 40 mg dose provides clinical benefit. No strong predictors of response were evident, with the exception of pain severity. Additional benefit for outcomes from higher doses, local anaesthetic, ultrasound guidance or particular anatomical approaches is yet to be demonstrated. Evidence for dose- and duration-related detrimental effects suggests judicious use and frequency. The evaluation showed that there are a number of contraindications and precautions arising from the drug pharmacology, concurrent medications, comorbidities and adverse events which need consideration and monitoring. There was limited safety evidence concerning anticoagulation. The review found that specialist guidance and limited evidence suggests that injection safety concerning warfarin may be enhanced by ensuring that the international normalized ratio level is within therapeutic range. However, the risk-benefit evaluation concerning non vitamin K antagonist oral anticoagulants remains challenging. Although there is published guidance, a lack of clinical studies, safety evidence and reversibility advocates caution. Overall, the review indicates that injection decisions and procedures need an individualized approach and supporting evidence is limited in many areas. Evaluation and discussion of benefits and risks, peri-procedural and post-injection management, and tailoring to the context and individuals' preferences are important in optimizing the benefits and safety of a knee injection.
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]Background and purpose - Platelet-rich plasma (PRP) is broadly used in the treatment of knee osteoarthritis, but clinical outcomes are highly variable. We evaluated the effectiveness of intra-articular injections with Autologous Conditioned Plasma (ACP), a commercially available form of platelet-rich plasma, in a tertiary referral center. Second, we aimed to identify which patient factors are associated with clinical outcome. Patients and methods - 140 patients (158 knees) with knee osteoarthritis (Kellgren and Lawrence grade 0-4) were treated with 3 intra-articular injections of ACP. The Knee Injury and Osteoarthritis Outcome Score (KOOS), pain (Numeric Rating Scale; NRS), and general health (EuroQol 5 Dimensions; EQ5D) were assessed at baseline and 3, 6, and 12 months' follow-up. The effect of sex, age, BMI, Kellgren and Lawrence grade, history of knee trauma, and baseline KOOS on clinical outcome at 6 and 12 months was determined using linear regression. Results - Mean KOOS increased from 37 at baseline to 44 at 3 months, 45 at 6 months, and 43 at 12 months' follow-up. Mean NRS-pain decreased from 6.2 at baseline to 5.3 at 3 months, 5.2 at 6 months, and 5.3 at 12 months. EQ5D did not change significantly. There were no predictors of clinical outcome. Interpretation - ACP does not lead to a clinically relevant improvement (exceeding the minimal clinically important difference) in patients suffering from knee osteoarthritis. None of the investigated factors predicts clinical outcome.
Innovative regenerative medicine in the management of knee OA: The role of Autologous Protein Solution. [2020]Osteoarthritis (OA) is one of the most common causes of chronic disability in adults due to pain and altered joint function. Although most patients report pain and functional limitation, symptoms, age of onset and disease progression are extremely variable. While inflammation could play a central role in the OA pathogenesis and progression, many underpinning mechanisms are still unclear. A number of proinflammatory mediators have been found in OA joints and could play a role, such as IL-1, IL-6, IL-7, IL-8, IL-15, IL-17, IL-18, TNF-alpha, macrophage chemotactic protein (MCP)-1, interferon-induced protein (IP)-10, monokine induced by interferon (MIG), oncostatin M (OSM), growth-related oncogene (GRO)-alpha, chemokine (C-C-motif) ligand 19 (CCL19), macrophage inflammatory protein (MIP)-1beta, and TGF-alpha. Biological approaches have recently got increasing interest due to their anti-inflammatory and immunomodulatory properties, regenerative potential, and high tolerability. The primary aim of this paper is to report the current concepts on regenerative medicine for knee OA with a particular focus on Autologous Protein solution (APS). APS is a blood derived product obtained by using a proprietary device, made of APS Separator, which isolates WBCs and platelets in a small volume of plasma, and APS Concentrator, which further concentrates platelets, WBCs and plasma proteins. The result is a peculiar formulation differing from other biologic products as it contains high levels of growth factors (EGF, IGF-1, PDGF-AB, PDGF-BB, VEGF, TGF-β1) along with high concentrations of anti-inflammatory mediators (IL-1ra, sIL-1RII, sTNF-RI, sTNF-RII) and low levels of pro-inflammatory cytokines (Il-1β and TNF-α). While emerging evidence supports the use of APS, as confirmed by in vitro studies and preliminary clinical results, the real clinical potential of APS and its benefits are still under investigation.
Pain control and functional improvement in patients treated by autologous conditioned serum after failure of platelet rich plasma treatments in knee osteoarthritis. [2022]To assess the efficacy of autologous conditioned serum (ACS) for the treatment of patients with knee osteoarthritis after failure of medical treatments and platelet rich plasma (PRP) injections.
Stimulation of the superficial zone protein and lubrication in the articular cartilage by human platelet-rich plasma. [2022]Platelet-rich plasma (PRP) contains high concentrations of autologous growth factors that originate from platelets. Intra-articular injections of PRP have the potential to ameliorate the symptoms of osteoarthritis in the knee. Superficial zone protein (SZP) is a boundary lubricant in articular cartilage and plays an important role in reducing friction and wear and therefore is critical in cartilage homeostasis.
Comparison Analysis of Autologous Conditioned Plasma. [2017]Autologous Conditioned Plasma (ACP) has a wide range of potential uses in modern orthopaedics. The aim of this study was to examine the characteristics of proprietary ACP and compare them with those of ACP produced using a commercially available kit.