Evaluation of a Single Intra‐Articular Injection of Autologous Protein Solution for Treatment of Osteoarthritis in a Canine Population

Wanstrath, Audrey W.; Hettlich, Bianca Felicitas; Su, Lillian; Smith, Ashley; Zekas, Lisa J.; Allen, Matthew J.; Bertone, Alicia L.

doi:10.1111/vsu.12512

Cited by 47 publications

(55 citation statements)

References 39 publications

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“…There were minor AE related to the injection procedure, including injection site discomfort (1/11), injection site joint pain (1/11), and procedural nausea (1/11), which resolved quickly and did not require treatment . In a randomized and controlled equine and canine trials there were no complications seen with injections of APS or saline. Ongoing randomized and controlled clinical trials will provide further evidence regarding the effect of APS on joint pain in the days post‐injection.…”

Section: Discussionmentioning

confidence: 99%

Human blood‐based anti‐inflammatory solution inhibits osteoarthritis progression in a meniscal‐tear rat study

King

Bendele

Marohl

et al. 2017

Journal Orthopaedic Research

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Current osteoarthritis (OA) research searches for treatments that modify the course of disease progression. Autologous Protein Solution (APS) is derived from whole blood and is a unique autologous therapy that contains high concentrations of white blood cells, platelets, and concentrated plasma, providing cytokines that can target the underlying mechanisms of disease progression. The APS Kit is currently under investigation for clinical use in the USA (NCT02262364). The aim of this study was to determine if APS has disease-modifying properties in the well-characterized rat meniscal tear-induced model of OA. Thirty male athymic rats underwent surgery to induce OA by a complete tear of the medial meniscus of the right knee. Seven days later, rats were administered 50 μl intra-articular (IA) APS from a human donor or phosphate buffered saline (PBS) control. Rats were euthanized 3 weeks following treatment and knee joints were processed for histological analysis. Collagen and cartilage degeneration were decreased by APS treatment, resulting in a significantly improved total joint score in APS-treated rats compared to those treated with the PBS control. No significant variations in gait analysis, weight gain, osteophyte score, or synovitis score were observed between APS- and PBS-treated animals. There were no adverse effects of APS reported in the study. Treatment with a single IA injection of APS reduced the cartilage degeneration that characterizes the progression of OA. Further studies are necessary to determine if APS can modify OA disease progression in humans. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:2260-2268, 2017.

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Section: Discussionmentioning

confidence: 99%

Human blood‐based anti‐inflammatory solution inhibits osteoarthritis progression in a meniscal‐tear rat study

King

Bendele

Marohl

et al. 2017

Journal Orthopaedic Research

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“… 21 In randomized and controlled large animal studies, APS has improved lameness in both horses 22 and dogs with naturally occurring OA. 23 A human clinical study demonstrated that APS contained high concentrations of anti-inflammatory cytokines and anabolic growth factors from 105 patients with OA. 24 Finally, a feasibility study and a randomized, controlled study have demonstrated that the output of the APS device is safe when injected intra-articularly and provided significantly improved pain compared to saline control 1 year after a single injection of APS.…”

Section: Introductionmentioning

confidence: 99%

An Autologous Anti-Inflammatory Protein Solution Yielded a Favorable Safety Profile and Significant Pain Relief in an Open-Label Pilot Study of Patients with Osteoarthritis

Hix¹,

Klaassen²,

Foreman³

et al. 2017

BioResearch Open Access

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Osteoarthritis (OA) is a progressive and degenerative disease, which may result in significant pain and decreased quality of life. Recent updates in our understanding of OA have demonstrated that it is a whole joint disease that has many similarities to an unhealed wound containing inflammatory cytokines. The nSTRIDE Autologous Protein Solution (APS) Kit is a medical device under development for the treatment of OA. The APS Kit processes a patient's own blood at the point of care to contain high concentrations of anti-inflammatory cytokines and anabolic growth factors. This study assessed the safety and treatment effects of a single intra-articular injection of APS. Eleven patients were enrolled in this study. Sufficient blood could not be drawn from one patient who was subsequently withdrawn, leaving 10 patients treated. Minor adverse events (AEs) were experienced by seven subjects (63.6%). There was one serious AE (diverticulitis) unrelated to the device or procedure. One subject experienced AEs that were judged “likely” to be procedure related (arthralgia/musculoskeletal discomfort) and all resolved within 6 days of injection. All other AEs were unrelated to the device or procedure. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores improved significantly over time (ANOVA, p < 0.0001, 12.0 ± 1.2 preinjection, 3.3 ± 2.9 one year postinjection, and 72.5% WOMAC pain improvement). There was significant positive correlation between white blood cell concentration in APS and improvement in WOMAC pain scores.

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“…These studies also offer the option for a client assessment study with the collection of data on client opinion and perception of their animal improvement which can give an estimate of the public reception to the treatment. In dogs with OA, similar standardized client questionnaires (21, 23) have been used to observe the well accepted measures of pain at home, such as climbing stairs, jumping into the car or on the couch, getting up for treats, or circling before bedding. These instrument surveys capture these subjective but valid assessments at home.…”

Section: Discussionmentioning

confidence: 99%

“…To adequately compare data that included forelimbs and hindlimbs, each horse was used as its own control and values were expressed as a ratio to baseline and as an asymmetry index (AI). AI between lame and contralateral limbs were expressed as a percent (21–23) and calculated as follows:

(VFP {(VFI)}_{Contralateral} - VFP {(VFI)}_{Lame}) \div ([VFP {(VFI)}_{Contralateral} + VFP {(VFI)}_{Lame}] \div 2) \times 100

(22). …”

Section: Methodsmentioning

confidence: 99%

“…For human cells, successful efficacy for cartilage repair has been demonstrated with allogeneic MSCs and chondrocytes (6, 8, 9, 12–15). Success of these cell-based biologic products has been ascribed to viable progenitor cells that could migrate, engraft, differentiate, and facilitate tissue regeneration (16), but more recently it has been recognized that MSC have anti-inflammatory (17, 18), immunomodulatory (5, 19, 20), and pain-relieving effects (21–23). Several available commercial devices can produce equine patient-side viable cell concentrates of bone marrow, 3 , 4 , 5 or adipose tissue, 6 , 7 and are designed for autologous use.…”

Section: Introductionmentioning

confidence: 99%

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Equine Dental Pulp Connective Tissue Particles Reduced Lameness in Horses in a Controlled Clinical Trial

et al. 2017

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ObjectiveTo assess if injection of allogeneic dental pulp tissue particles would improve lameness in horses with naturally occurring osteoarthritis (OA) or soft tissue (ST) injury.DesignProspective, randomized, blinded, and controlled clinical trial and client survey assessment.AnimalsForty lame client-owned horses.ProceduresSterile dental pulp, recovered from otherwise healthy foals that perish during dystocia, was processed under good manufacturing processing to produce mechanically manipulated, unexpanded pulp tissue particles containing viable cells surrounded in extracellular matrix. Forty lame client-owned horses with confirmed OA (n = 20), or ST injury (desmitis or tendonitis) received a 2 mL intra-articular (n = 20 OA) or intra-lesional (n = 20) injection of control transport vehicle (n = 20) or 10 × 106 dental pulp tissue particles (n = 20). Acclimatized horses had baseline measurements performed and were then injected on day 0. Horses were treadmill exercised for 2 weeks, evaluated by clinical parameters, lameness score, edema (score and circumference), pain on flexion (OA) or pressure (ST), and clients’ scores for pain and discomfort before and through 45 days after pulp injection. Twenty horses were available for >2.5-year follow-up.ResultsPulp-treated horses showed decrease in lameness compared to baseline (P < 0.009) or placebo controls (P < 0.013) for at least 2 weeks. Client assessments of comfort were improved between before and 45 days after pulp injection (P < 0.001). Clinical improvement with ST injury was significantly greater than OA (P < 0.001). At >2.5-year follow-up, at least 10 horses were in work.Conclusion and clinical relevanceDental pulp tissue particles can be considered as a treatment option for equine lameness due to OA, desmitis, or tendonitis.

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Evaluation of a Single Intra‐Articular Injection of Autologous Protein Solution for Treatment of Osteoarthritis in a Canine Population

Abstract: APS injection reduced pain and lameness scores and increased weight-bearing associated with the OA-affected joint in dogs at 12 weeks providing preliminary evidence that APS therapy may be beneficial in the treatment of OA in dogs and supporting pursuit of additional studies.

Cited by 47 publications

References 39 publications

Human blood‐based anti‐inflammatory solution inhibits osteoarthritis progression in a meniscal‐tear rat study

Human blood‐based anti‐inflammatory solution inhibits osteoarthritis progression in a meniscal‐tear rat study

An Autologous Anti-Inflammatory Protein Solution Yielded a Favorable Safety Profile and Significant Pain Relief in an Open-Label Pilot Study of Patients with Osteoarthritis

Equine Dental Pulp Connective Tissue Particles Reduced Lameness in Horses in a Controlled Clinical Trial

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