Clinical Data

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 Pro-Stride APS is referenced as APS in some of the below clinical publications.

Evaluation of a single intra-articular injection of autologous protein solution for treatment of osteoarthritis in horses

A. Bertone (American Journal of Veterinary Research 2014; 75: 141-151)

 

Objective—To evaluate intra-articular autologous protein solution (APS) for the treatment of osteoarthritis in horses.

 

Animals—40 client-owned horses with naturally occurring osteoarthritis.

 

Procedures—APS was generated from a dual-device system that concentrated plasma and WBC proteins and enriched platelet growth factors. Horses were randomly assigned to receive an intra-articular injection of 5 mL of saline (0.9% NaCl) solution (n = 20) or APS (20), exercised on a treadmill, and evaluated on the basis of lameness grades, kinetic gait analysis, joint circumference, and range of motion for 14 days. Horses that received saline solution were administered APS at termination of the study, and clients scored horses for lameness and discomfort before, 12 weeks after, and 52 weeks after the APS injection.

 

Results—The APS group had significant improvements in lameness grade, asymmetry indices

of vertical peak force, and range of joint motion by 14 days, compared with baseline or control group values. No adverse effects associated with APS treatment were evident. Clients assessed lameness and comfort as improved at 12 and 52 weeks. The APS had greater likelihood (OR, 4.3 to 30.0) of a therapeutic response in horses with a lameness score < 4, < 10% vertical force asymmetry, or absence of marked osteophyte formation, subchondral sclerosis, or joint space narrowing. Concentration of interleukin-1 receptor antagonist in APS was 5.8 times that in blood.

 

Conclusions and Clinical Relevance—Intra-articular administration of APS can be considered

an effective treatment option for equine osteoarthritis, with the potential for disease-modifying

effects.

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

 

A. Wanstrath / A. Bertone (Veterinary Surgery 2016 Aug; 45 (6):764-74)

Department of Veterinary Clinical Sciences, College of Veterinary Medicine, The Ohio State University, Columbus, Ohio

 

Objective: To evaluate the safety and efficacy of an intra-articular injection of autologous protein solution (APS) for treatment of canine osteoarthritis (OA).

 

Study Design: Prospective, randomized, blinded, placebo-controlled pilot clinical trial.

 

Animals: Client-owned dogs with single limb lameness because of OA in a stifle or elbow joint (n521).

 

Methods: Lame dogs, confirmed with OA by physical and lameness examination and imaging, were randomly assigned to control or treatment groups. Owners, blinded to treatment, scored pain (University of Pennsylvania Canine Brief Pain Inventory) and lameness severity (Hudson Visual Analogue Scale [HVAS]). Weight-bearing was assessed by kinetic gait analysis. Dogs were injected intra-articularly with APS (treatment group) or saline solution (control group). Evaluations were performed before injection, and 2 and 12 weeks post-injection.

 

Results: Compared to pretreatment values, APS treatment data showed a significant improvement in week 12 pain scores (improved 25.6% over baseline), lameness scores (improved 15% over baseline) and peak vertical force (PVF; N/kg; increased 14.9% of baseline), as well as vertical impulse (Ns/kg) and PVF normalized to stance

time (N/kg/s). Control group dogs improved at week 2 in owner assigned indices, but not force plate values and had no significant improvement in scores or force plate values from pretreatment values at 12 weeks.

 

Conclusion: 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 the pursuit of additional studies.

A Pilot Clinical Study Assessing Treatment of Canine Hip Dysplasia Using Autologous Protein Solution

Samuel P. Franklin (Frontiers in Veterinary Science: August 2019; Volume 6; Article 243)

Colorado Canine Orthopedics and Rehab, Colorado Springs, CO, United States

SummaryFive dogs with bilateral hip dysplasia and without osteoarthritis of other joints were enrolled in this pilot study. Objective kinetic data using a pressure sensitive mat and owner assessments using the canine brief pain inventory (CBPI) and Liverpool Osteoarthritis for Dogs (LOAD) questionnaires were obtained prior to treatment. Enrolled dogs were treated in one hip with autologous protein solution (APS) and the contralateral hip was injected with an equal volume of saline. The hip to be treated was selected using a random number generator. At exactly 28 days following treatment dogs were re-assessed using the pressure sensitive mat and the CBPI and LOAD questionnaires. No dogs were treated with any other medications or supplements throughout the study period. Assessment of the total pressure index (TPI) collected using the pressure sensitive mat showed that the hips treated with APS improved significantly more than hips treated with saline (p = 0.0005) and that the hips treated with APS bore significantly more weight than the hips treated with saline at day 28 (p < 0.05). Statistically significant improvement was noted by owners in “pain” and “function” as assessed by the CBPI as well “mobility at exercise” using the LOAD questionnaire. This pilot study provided proof of principle that APS is beneficial in treating pain and lameness in dogs affected by coxofemoral osteoarthritis.

Cox-inhibitors do not impact anti-inflammatory IL-1ra concentrations in Autologous Protein Solution (Equine)

 

Abstract - Presented at International Cartilage Repair Society - Naples, Italy - Sept 2016

 

Purpose

Autologous Protein Solution (APS) is prepared at the point-of-care from whole blood and contains high concentrations of white blood cells, platelets, and anti-inflammatory cytokines. APS has been shown to improve equine lameness and range of motion when administered via intra-articular (IA) injection for the treatment of osteoarthritis (OA).1 The immunosuppressive steroids methylprednisolone and triamcinolone are frequently administered via IA to horses and humans as the supplementary treatment for the inflammation associated with OA. 2 It was previously unknown whether concurrent or successive treatment with one of these steroids and APS would impact the cytokine output of the APS treatment.  

 

Conclusion

The combination of steroids with APS did not reduce the concentrations of IL-1ra. This finding suggests that concurrent or successive treatment of OA with methylprednisolone or

triamcinolone and APS does not impact the cytokine content in APS. A future study evaluating the clinical effects of APS and steroids could determine an effective administration protocol for these OA treatments. 

Steroids methylprednisolone and triamcinolone do not impact anti- inflammatory IL-1ra concentrations in Autologous Protein Solution (Equine)

 

Abstract - Presented at International Cartilage Repair Society - Naples, Italy - Sept 2016

 

Purpose

Autologous Protein Solution (APS) is an autologous therapy containing high concentrations of

white blood cells, platelets, and anti-inflammatory cytokines.1 APS has been shown to improve

lameness and range of motion when administered via intra-articular (IA) injection to horses with

osteoarthritis (OA).2 The Cox-inhibiting drugs phenylbutazone, flunixin meglumine, and

firocoxib are administered to horses to treat the inflammation and pain associated with OA.3,4 It

was previously unknown whether Cox-inhibitor treatment prior to the time of blood draw for

APS treatment would influence the IL-1ra or IL-1β concentrations in APS.

 

Conclusion

Cox-inhibitor presence in equine blood used to produce APS did not impact the concentrations of

the anti-inflammatory cytokine IL-1ra. This outcome suggests that equine treatment of OA with

phenylbutazone, flunixin meglumine, or firocoxib prior to the blood draw for APS production does

not alter the cytokine content of APS.

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