Comparison of the hospital costs for two-stage reimplantation for deep infection, single-stage revision and primary total elbow arthroplasty.

BACKGROUND: The purpose of the present study was to determine the cost of two-stage reimplantation for the treatment of deep infection after total elbow arthroplasty (TEA) and compare this with primary and aseptic revision TEA. METHODS: Three hundred and seventy-one primary TEA and 286 revision TEAs (including 47 elbows requiring two-stage reimplantation) were performed. Total direct medical costs during each hospitalization were obtained from our institutional research database and compared for three groups: primary TEA, revision for nonseptic reasons and two-stage reimplantation for deep infection. RESULTS: The mean cost of an uncomplicated primary TEA and aseptic revision TEA was $18,464 and $18,796, respectively. The mean overall cost associated with two-stage reimplantation increased to $34,286. Two-stage reimplantation increased both Part A (hospital costs) and Part B (professional costs). The mean Part A cost for septic revision TEA was $29,102 versus $15,844 for primary TEA. The mean Part B cost for septic revision TEA was $5,184 versus $2,621 for primary TEA. CONCLUSIONS: Two-stage reimplantation for treatment of an infected TEA costs 186% the hospital cost of a primary uncomplicated or aseptic revision TEA. The overall cost to society is even greater if we take into account the cost of antibiotic therapy in between stages and lost days from work.

A quantitative, multi-national and multi-stakeholder assessment of barriers to the adoption of cell therapies.

Cellular therapies, such as stem cell-based treatments, have been widely researched and numerous products and treatments have been developed. Despite this, there has been relatively limited use of these technologies in the healthcare sector. This study sought to investigate the perceived barriers to this more widespread adoption. An anonymous online questionnaire was developed, based on the findings of a pilot study. This was distributed to an audience of clinicians, researchers and commercial experts in 13 countries. The results were analysed for all respondents, and also sub-grouped by geographical region, and by profession of respondents. The results of the study showed that the most significant barrier was manufacturing, with other factors such as efficacy, regulation and cost-effectiveness being identified by the different groups. This study further demonstrates the need for these important issues to be addressed during the development of cellular therapies to enable more widespread adoption of these treatments.

Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study.

There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community.

The implementation of novel collaborative structures for the identification and resolution of barriers to pluripotent stem cell translation.

Increased global connectivity has catalyzed technological development in almost all industries, in part through the facilitation of novel collaborative structures. Notably, open innovation and crowd-sourcing-of expertise and/or funding-has tremendous potential to increase the efficiency with which biomedical ecosystems interact to deliver safe, efficacious and affordable therapies to patients. Consequently, such practices offer tremendous potential in advancing development of cellular therapies. In this vein, the CASMI Translational Stem Cell Consortium (CTSCC) was formed to unite global thought-leaders, producing academically rigorous and commercially practicable solutions to a range of challenges in pluripotent stem cell translation. Critically, the CTSCC research agenda is defined through continuous consultation with its international funding and research partners. Herein, initial findings for all research focus areas are presented to inform global product development strategies, and to stimulate continued industry interaction around biomanufacturing, strategic partnerships, standards, regulation and intellectual property and clinical adoption.