Clinical Evaluation of Safety and Efficacy of a Central Current Good Manufacturing Practices Laboratory Produced Autologous Adipose-Derived Stromal Vascular Fraction Cell Therapy Product for the Treatment of Knee Osteoarthritis.

Knee osteoarthritis (KOA) is a prevalent condition characterized by the progressive deterioration of the entire joint and has emerged as a prominent contributor to disability on a global scale. The nature of the disease and its impact on joint function significantly limit mobility and daily activities, highlighting its substantial influence on patients' overall well-being. Stromal vascular fraction (SVF) is a heterogenous, autologous cell product, containing mesenchymal stem cells, derived from the patient's subcutaneous adipose tissue with demonstrated safety and efficacy in the treatment of KOA patients.

A pilot study testing an Achilles tendinopathy human cadaver model using intratendinous injection of collagenase.

Background: Achilles tendinopathy is one of the most frequently occurring soft-tissue injuries. Despite decades of research, there is still much that is unknown about the progression of tendinopathy. Animal models, such as collagenase injection, allow researchers to gain insight into disease progression and investigate clinical interventions, yet are limited in their direct application to humans.

Orthobiologic Standardization and Clinical Outcome Measurement.

There is a pressing need for the standardization of orthobiologics, considering the cellular components, concentrations, and methods of injections may vary wildly, currently without significant standards of care. There is a growing body of evidence that these factors matter significantly for patient outcomes, so it is imperative that orthobiologic constituents are measured and standardized. Cell counts may be performed for platelet-rich plasma and bone marrow aspirate-based injections, whereas adipose should have standardized processing techniques as cellular quantification is more difficult.

Adipose cellular injection in the treatment of an intrasubstance Achilles tendon defect: a case report.

Our patient presented with a 1-year history of right sided Achilles tendon pain and weakness due to partial intrasubstance tear. The injury was refractory to conservative treatment, leading to a trial injection of microfragmented adipose tissue. Progressive healing and improved function were documented on physical exam and sonographically at subsequent follow-up appointments.

Patient registries in orthopedics and orthobiologic procedures: a narrative review.

There has been increasing evidence and growing popularity of orthobiologic treatments, such as platelet-rich plasma, bone marrow aspirate concentrate, and microfragmented adipose tissue. However, real-world data, including patient-reported pain and function outcomes, remains sparse for these procedures. Thus, collecting patient-reported outcome measures is important to evaluate the safety and efficacy of these treatments and hopefully improve patient care.

Delay to TKA in Patients Treated with a Multimodal Approach Using High Molecular Weight, Biologically Derived Hyaluronic Acid.

Background: The primary objective of this study was to determine the effect of single versus multiple rounds of intra-articular hyaluronic acid (IA-HA) in delaying the need for total knee arthroplasty (TKA) in patients with knee OA, and if additional benefits were seen when used in conjunction with other multimodal treatment options.

Methods: This study was a retrospective claims analysis of a large commercial database containing more than 100 million patients with continuous coverage from October 1, 2010 through September 30, 2015. Time to TKA for patients who received one course of Euflexxa (IA-BioHA) were compared to patients who received two or more courses of IA-BioHA and patients who received no IA-HA.

Use of Bone Marrow Concentrate to Treat Pain and Musculoskeletal Disorders: An Academic Delphi Investigation.

Background: Acute and degenerative musculoskeletal disorders are among the most common etiologies of disability worldwide. Recently, there has been interest in the field of regenerative medicine to bridge the gap between conservative and surgical management of these conditions. Autologous bone marrow concentrate is one type of injectate that has increased in popularity over the last few decades.

A pilot study to evaluate micro-fragmented adipose tissue injection under ultrasound guidance for the treatment of refractory rotator cuff disease in wheelchair users with spinal cord injury.

Context/objectives: Wheelchair users with chronic shoulder pain have few options after conservative treatments fail. This pilot study's purpose was to establish safety and treatment effects of micro-fragmented adipose tissue (MFAT) injections under ultrasound guidance for treatment of refractory shoulder pain caused by rotator cuff disease in wheelchair users with spinal cord injury (SCI) to prepare for a larger trial.

Design: Pilot clinical trial.

Chronic prosthesis-related residual limb ulcer treated with autologous micro-fragmented adipose tissue.

A 56-year-old male with a past medical history significant for a left below-knee amputation and a left total knee replacement presented with knee pain at a non-healing stage 2 prosthesis-related residual limb ulcer. The ulcer at the weight-bearing surface at the anterior patella had not closed despite three years of conservative management; including offloading and wound clinic follow up. To assist with the healing process, the ulcer was treated with autologous micro-fragmented adipose tissue therapy.

A Narrative Review Evaluating Extracorporeal Shockwave Therapy as a Potential Regenerative Treatment for Musculoskeletal Conditions in Military Personnel.

Introduction: Extracorporeal shockwave therapy (ESWT) has a wide variety of clinical applications ranging from urology to orthopedics. Extracorporeal shockwave therapy is of particular interest to military medicine in the treatment of diverse musculoskeletal injuries, including recalcitrant tendinopathy. Much of the evidence for ESWT is from studies in the civilian population, including athletes.

Corticosteroids: Review of the History, the Effectiveness, and Adverse Effects in the Treatment of Joint Pain.

Background: Corticosteroids have been used for the past 70 years in the treatment of various musculoskeletal conditions. This includes its use for joint pain such as rheumatoid arthritis and osteoarthritis.

Objectives: A narrative review of the literature from its initial discovery to the present day to summarize the research of corticosteroids for joint pain to determine the safety and effectiveness of this commonly used and prescribed medication.

Platelet-Rich Plasma Applications for Achilles Tendon Repair: A Bridge between Biology and Surgery.

Achilles tendon ruptures are very common tendon ruptures and their incidence is increasing in modern society, resulting in work incapacity and months off sport, which generate a need for accelerated and successful therapeutic repair strategy. Platelet-rich plasma (PRP) is emerging as adjuvant human blood-derived constructs to assist Achilles tendon rupture treatment. However, myriad PRP preparation methods in conjunction with poor standardization in the modalities of their applications impinge on the consistent effectiveness of clinical and structural outcomes regarding their therapeutic efficacy.

Knee Osteoarthritis Treatment Costs in the Medicare Patient Population.

Background: Several nonoperative options have been recommended for the treatment of knee osteoarthritis (OA), with varying degrees of evidence. Adhering to the American Academy of Orthopaedic Surgeons clinical practice guidelines has been suggested to decrease direct treatment costs by 45% in the year before knee arthroplasty, but this does not consider the cost of the entire episode of care, including the cost of surgery and postsurgery care.

Objectives: To analyze the total treatment costs after a diagnosis of knee OA, as well as the proportion of arthroplasty interventions as part of the total knee OA-related costs, and whether the total costs differed for patients who received intra-articular hyaluronic acid and/or had knee arthroplasty.

Clinical evaluation of micro-fragmented adipose tissue as a treatment option for patients with meniscus tears with osteoarthritis: a prospective pilot study.

Purpose: The management of knee pain secondary to meniscal tears with osteoarthritis is limited by the poor inherent healing potential of the meniscus. Previous studies have reported on the benefit of autologous micro-fragmented fat as a therapeutic for various knee pathologies. The goal of this prospective pilot study was to determine the safety and potential treatment effect of micro-fragmented adipose tissue injection for patients with knee pain secondary to osteoarthritis and meniscal tears who have failed conservative management.

Decrease in opioid and intra-articular corticosteroid burden after intra-articular hyaluronic acid for knee osteoarthritis treatment.

We studied changes in opioid prescriptions and corticosteroid injection use for knee osteoarthritis patients before and after intra-articular hyaluronic acid (HA) use and opioid prescriptions before and after knee arthroplasty (KA).  A total of 1,017,578 knee osteoarthritis members were ascertained from a commercial claims database (Health Intelligence Company LLC, IL, USA) using ICD9/ICD10 diagnosis codes.  Eighty two percent of HA patients did not fill opioid prescriptions postinjection, with 54% of opioid users discontinuing fills.

Platelet-rich plasma for the treatment of knee osteoarthritis: an expert opinion and proposal for a novel classification and coding system.

Introduction: Platelet-rich plasma (PRP) is able to modulate the joint environment by reducing the inflammatory distress and promoting tissue anabolism. Therefore, it has gained increasing popularity among clinicians in the treatment of osteoarthritis (OA), and it is currently proposed beside consolidated options such as viscosupplementation.

Areas Covered: A systematic review of all available meta-analyses evaluating intra-articular PRP injections in patients affected by knee OA was performed, to understand how this biologic treatment approach compares to the traditional injective therapies available in clinical practice.

Ultrasound-guided platelet-rich plasma injection for the treatment of recalcitrant rotator cuff disease in wheelchair users with spinal cord injury: A pilot study.

Wheelchair users with spinal cord injury (SCI) have a high risk of developing shoulder pain, caused by rotator cuff disease. Platelet-rich plasma (PRP) is a potential treatment after conservative treatments fail and prior to surgical intervention; however, it has not been tested in wheelchair users who have recalcitrant shoulder pain associated with rotator cuff disease. The objective of this pilot project was to test the safety and potential treatment effect of an ultrasound-guided PRP injection for shoulder pain in the aforementioned population.

Bone Marrow Concentrate (BMC) Therapy in Musculoskeletal Disorders: Evidence-Based Policy Position Statement of American Society of Interventional Pain Physicians (ASIPP).

Background: The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration's (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine.

Autologous, micro-fragmented adipose tissue as a treatment for chronic shoulder pain in a wheelchair using individual with spinal cord injury: a case report.

Introduction: Shoulder pain is common in persons with chronic spinal cord injury (SCI), with a prevalence reported as high as 70%. Current treatment of shoulder pain includes conservative measures such as physical therapy, pain medications, patient education, injections, and assistive devices. When conservative treatments fail, shoulder surgery is often the next option.

Assessing clinical implications and perspectives of the pathophysiological effects of erythrocytes and plasma free hemoglobin in autologous biologics for use in musculoskeletal regenerative medicine therapies. A review.

Autologous biologics, defined as platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMC), are cell-based therapy treatment options in regenerative medicine practices, and have been increasingly used in orthopedics, sports medicine, and spinal disorders. These biological products are produced at point-of-care; thereby, avoiding expensive and cumbersome culturing and expansion techniques. Numerous commercial PRP and BMC systems are available but reports and knowledge of bio-cellular formulations produced by these systems are limited.

Treatment of Knee Meniscus Pathology: Rehabilitation, Surgery, and Orthobiologics.

The meniscal tear treatment paradigm traditionally begins with conservative measures such as physical therapy and referral for operative management for persistent or mechanical symptoms. As a result, the partial meniscectomy is performed more than any other orthopedic procedure in the United States. This treatment paradigm has shifted because recent literature has supported the attempt to preserve or repair the meniscus whenever possible given its importance for the structural integrity of the knee joint and the risk of early osteoarthritis associated after meniscus excision.

The Role of Low-Intensity Pulsed Ultrasound on Cartilage Healing in Knee Osteoarthritis: A Review.

Unlabelled: Ultrasound (US) is a therapeutic modality that has been used in the treatment of musculoskeletal conditions for decades. In recent years, there have been technological advancements using low-intensity pulsed ultrasound (LIPUS) as a clinical modality. The purpose of this review was to critically examine the medical literature to determine the effects of LIPUS on the chondrogenic properties of knee osteoarthritis.