Optimizing large‐scale autologous human keratinocyte sheets for major burns—Toward an animal‐free production and a more accessible clinical application

Inborn errors of metabolism (IEM) are inherited conditions caused by genetic defects in enzymes or cofactors. These defects result in a specific metabolic fingerprint in patient body fluids, showing accumulation of substrate or lack of an end-product of the defective enzymatic step. Untargeted metabolomics has evolved as a high throughput methodology offering a comprehensive readout of this metabolic fingerprint. This makes it a promising tool for diagnostic screening of IEM patients. However, the size and complexity of metabolomics data have posed a challenge in translating this avalanche of information into knowledge, particularly for clinical application. We have previously established next-generation metabolic screening (NGMS) as a metabolomics-based diagnostic tool for analyzing plasma of individual IEM-suspected patients. To fully exploit the clinical potential of NGMS, we present a computational pipeline to streamline the analysis of untargeted metabolomics data. This pipeline allows for time-efficient and reproducible data analysis, compatible with ISO:15189 accredited clinical diagnostics. The pipeline implements a combination of tools embedded in a workflow environment for large-scale clinical metabolomics data analysis. The accompanying graphical user interface aids end-users from a diagnostic laboratory for efficient data interpretation and reporting. We also demonstrate the application of this pipeline with a case study and discuss future prospects.

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Evaluation of five cell-free DNA isolation kits for plasma

10.1101/715821 ◽

2019 ◽

Author(s):

Zhongzhen Liu ◽

Xi Yang ◽

Haixiao Chen ◽

Sujun Zhu ◽

Juan Zeng ◽

...

Keyword(s):

Clinical Application ◽

Large Scale ◽

Circulating Dna ◽

Cell Free Dna ◽

Non Invasive ◽

Free Dna ◽

Prenatal Test ◽

Wide Scale ◽

The Cost ◽

Pooled Samples

AbstractCell-free DNA (cfDNA) has been widely used in prenatal test and cancer diagnosis nowadays. The cost- and time-effective isolation kits are needed especially in large-scale clinical application. Here, we compared three domestic kits: VAHTS Serum/Plasma Circulating DNA kit (VZ), MagPure Gel Pure DNA mini kit (MG) and Serum/Plasma Circulating DNA Kit (TG), together with QIAamp Circulating Nucleic Acid Kit (QC) and QIAamp DNA Blood Mini Kit (QD) in cfDNA isolation. cfDNA was isolated from the pooled samples with spike-in fragments, qPCR was conducted to quantify the spike-in fragments recovery. The results indicated that all of the five kits could isolate cfDNA with different efficiency. The VZ kit had an efficiency as high as 90 percent, which is comparable to QC kit. The libraries were constructed using the isolated cfDNAs, quantified by Qubit and analyzed by 2100 bioanalyzer. Both showed the libraries were qualified. Finally, cffDNAs were detected by qPCR targeting SRY gene using libraries from pregnant women bearing male fetuses. All five kits could isolate cffDNAs that could be detected by qPCR. Our results provided more choices in wide-scale clinical application of cfDNA-based non-invasive genetic tests.

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Large-scale generation of mature monocyte-derived dendritic cells for clinical application in cell factories™

Journal of Immunological Methods ◽

10.1016/s0022-1759(02)00189-8 ◽

2002 ◽

Vol 268 (2) ◽

pp. 131-140 ◽

Cited By ~ 96

Author(s):

Thomas G Berger ◽

Bernadette Feuerstein ◽

Erwin Strasser ◽

Ute Hirsch ◽

Doris Schreiner ◽

...

Keyword(s):

Dendritic Cells ◽

Clinical Application ◽

Large Scale ◽

Cell Factories

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Clinical Application of Radioembolization in Hepatic Malignancies: Protocol for a Prospective Multicenter Observational Study (Preprint)

10.2196/preprints.16296 ◽

2019 ◽

Author(s):

Thomas Helmberger ◽

Dirk Arnold ◽

José I Bilbao ◽

Niels de Jong ◽

Geert Maleux ◽

...

Keyword(s):

Observational Study ◽

Clinical Application ◽

Treatment Modality ◽

Large Scale ◽

Liver Tumors ◽

Real Life ◽

Routine Practice ◽

Resin Microspheres ◽

The Impact

BACKGROUND Radioembolization, also known as transarterial radioembolization or selective internal radiation therapy with yttrium-90 (90Y) resin microspheres, is an established treatment modality for patients with primary and secondary liver tumors. However, large-scale prospective observational data on the application of this treatment in a real-life clinical setting is lacking. OBJECTIVE The main objective is to collect data on the clinical application of radioembolization with 90Y resin microspheres to improve the understanding of the impact of this treatment modality in its routine practice setting. METHODS Eligible patients are 18 years or older and receiving radioembolization for primary and secondary liver tumors as part of routine practice, as well as have signed informed consent. Data is collected at baseline, directly after treatment, and at every 3-month follow-up until 24 months or study exit. The primary objective of the Cardiovascular and Interventional Radiological Society of Europe Registry for SIR-Spheres Therapy (CIRT) is to observe the clinical application of radioembolization. Secondary objectives include safety, effectiveness in terms of overall survival, progression-free survival (PFS), liver-specific PFS, imaging response, and change in quality of life. RESULTS Between January 2015 and December 2017, 1047 patients were included in the study. The 24-month follow-up period ended in December 2019. The first results are expected in the third quarter of 2020. CONCLUSIONS The CIRT is the largest observational study on radioembolization to date and will provide valuable insights to the clinical application of this treatment modality and its real-life outcomes. CLINICALTRIAL ClinicalTrials.gov NCT02305459; https://clinicaltrials.gov/ct2/show/NCT02305459 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/16296

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