Notes

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No statistically significant difference was observed in the CCI scores (15 vs. 20.8; P=0.6). Complications occurred in 9 (64%) and 8 (50%) patients in the REVERSAL and NON-REVERSAL groups, respectively (P=0.48). No gastro-intestinal leaks or post-operative mortality occurred.

Stoma reversal during hepatectomy for liver metastasis from a primary rectal cancer represents a safe alternative since post-operative outcome was not associated with additional morbidity in this series.
Stoma reversal during hepatectomy for liver metastasis from a primary rectal cancer represents a safe alternative since post-operative outcome was not associated with additional morbidity in this series.The establishment of a new profession requires anticipating its added value and defining its field of intervention. This article explores the needs of a model of care in kidney transplantation through the study of epidemiological data and an exploratory survey within a university hospital center in Île-de-France. The results define the limits of current care and assert the place of the advanced practice nurse in the renal transplantation sector. Her role is established with the patient and his entourage, the transplant center and the professionals of the city.
The National Institute for Health and Care Excellence criterion for hip replacements is a (projected) revision rate of less than 5% after 10 years. No such criterion is available for ankle prostheses. The objective of the current study is to compare survival rates of contemporary primary ankle prostheses to the hip-benchmark.

The PRISMA methodology was used. Eligible for inclusion were clinical studies reporting revision rates of currently available primary total ankle prostheses. Data was extracted using preconstructed forms. The total and prosthesis-specific annual revision rate was calculated.

Fifty-seven articles of eight different ankle prostheses were included (n = 5371), totaling 513 revisions at an average 4.6 years of follow-up. An annual revision rate of 2.2 was found (i.e. an expected revision rate of 22% at 10 years).

The expected 10-year revision rate of contemporary ankle prostheses is lower than the current benchmark for hip prostheses.
The expected 10-year revision rate of contemporary ankle prostheses is lower than the current benchmark for hip prostheses.Haemangioma is the most frequent benign hepatic tumour. Haemangioma is generally asymptomatic but it can sometimes cause disabling symptoms depending on its size and location. Surgery and interventional radiology are the cornerstone of the treatment in this situation. Radiation therapy, already used with good efficacy and safety to treat hepatic malignant lesions as hepatocarcinoma and metastases, is a relevant option in case of contraindication to surgery because of multiple or very large lesions. In this context, we report the case of a patient presenting with multiple symptomatic hepatic haemangiomas, successfully treated by radiation therapy in our department. These good results justified a review of the literature to report series of patients treated in this indication and to describe the main treatment regimens used.
Cell-based regenerative medicine is an innovative field that can potentially alter the overall survival and quality of life of patients with devastating diseases. Several cell therapy products (CTPs) have been approved within the last two decades, and more are under development. The establishment of an effective developmental strategy in accordance with the regulatory bodies of each country/region is crucial for fast delivery of each respective CTP. In particular, facilitating investigational new drug (IND) approval is important for accelerating the transition from non-clinical to clinical research/trial phases.

Here the authors compared the non-clinical prerequisites for initiating clinical studies in five Asian countries/regions (India, China, Korea, Taiwan and Japan) from an industry viewpoint. The authors first identified the differences and tried to clarify the perspectives/considerations underpinning the different requirements.

The authors' findings revealed that differences in regulations and development experiences, especially with CTPs, have led to clear differences in the non-clinical study package and its corresponding study design.

By sharing experiences of the research and development of CTPs among Asian countries/regions and including not only industry but also regulatory authorities, we will be able to expedite cross-border IND approval and eventually contribute to the early delivery of innovative CTPs to many Asian patients.
By sharing experiences of the research and development of CTPs among Asian countries/regions and including not only industry but also regulatory authorities, we will be able to expedite cross-border IND approval and eventually contribute to the early delivery of innovative CTPs to many Asian patients.
Bioartificial liver devices (BALs) are categorized as advanced therapy medicinal products (ATMPs) with the potential to provide temporary liver support for liver failure patients. However, to meet commercial demands, next-generation BAL manufacturing processes need to be designed that are scalable and financially feasible. PF-04965842 research buy The authors describe the development and application of a process economics decisional tool to determine the cost of goods (COG) of alternative BAL process flowsheets across a range of industrial scales.

The decisional tool comprised an information database linked to a process economics engine, with equipment sizing, resource consumption, capital investment and COG calculations for the whole bioprocess, from cell expansion and encapsulation to fluidized bed bioreactor (FBB) culture to cryopreservation and cryorecovery. Four different flowsheet configurations were evaluated across demands, with cell factories or microcarriers in suspension culture for the cell expansion step and single-use or stainless steel technology for the FBB culture step.

The tool outputs demonstrated that the lowest COG was achieved with microcarriers and stainless steel technology independent of the annual demand (1500-30 000 BALs/year). The analysis identified the key cost drivers were parameters impacting the medium volume and cost.

The tool outputs can be used to identify cost-effective and scalable bioprocesses early in the development process and minimize the risk of failing to meet commercial demands due to technology choices. The tool predictions serve as a useful benchmark for manufacturing ATMPs.
The tool outputs can be used to identify cost-effective and scalable bioprocesses early in the development process and minimize the risk of failing to meet commercial demands due to technology choices. The tool predictions serve as a useful benchmark for manufacturing ATMPs.
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