Sustainable Primary Cell Banking for Topical Compound Cytotoxicity Assays: Protocol Validation on Novel Biocides and Antifungals for Optimized Burn Wound Care.

Thorough biological safety testing of topical therapeutic compounds and antimicrobials is a critical prerequisite for appropriate cutaneous wound care. Increasing pathogen resistance rates to traditional antibiotics and antifungals are driving the development and registration of novel chemical entities. Although they are notably useful for animal testing reduction, the gold standard in vitro cytotoxicity assays in continuous cell lines (HaCaT keratinocytes, 3T3 fibroblasts) may be discussed from a translational relevance standpoint.

Dual Functionalization of Hyaluronan Dermal Fillers with Vitamin B3: Efficient Combination of Bio-Stimulation Properties with Hydrogel System Resilience Enhancement.

Hyaluronic acid (HA) hydrogels are commonly used for facial dermal filling and for alternative medical aesthetic purposes. High diversity exists in commercial formulations, notably for the optimization of finished product stability, functionality, and performance. Polyvalent ingredients such as calcium hydroxylapatite (CaHA) or vitamin B3 (niacinamide) are notably used as bio-stimulants to improve skin quality attributes at the administration site.

Biogelx-IKVAV Is An Innovative Human Platelet Lysate-Adipose-Derived Stem Cells Delivery Strategy to Improve Peripheral Nerve Repair.

Adipose-derived stem cells (ADSC) are nowadays one of the most exploited cells in regenerative medicine. They are fast growing, capable of enhancing axonal elongation, support and locally stimulate Schwann cells (SCs), and protect de-innervated muscles from atrophy after a peripheral nerve injury. With the aim of developing a bio-safe, clinically translatable cell-therapy, we assessed the effect of ADSC pre-expanded with human platelet lysate in an rat model, delivering the cells into a 15 mm critical-size sciatic nerve defect embedded within a laminin-peptide-functionalized hydrogel (Biogelx-IKVAV) wrapped by a poly-ɛ-caprolactone (PCL) nerve conduit.

Indications, outcomes, and complications of neoumbilical reconstruction: A systematic review.

Background And Objectives: Neoumbilicoplasty aims to reconstruct an aesthetically pleasing new umbilicus following agenesis, malignancy, anatomical distortion, or umbilicus loss. Despite the wide variety of surgical techniques described, literature is scarce when it comes to standardized categorization of these as well as the clear definition of patients' selections, specific indications, final outcomes, and possible complications. According to available literature, this work aims to evaluate different surgical approaches, and correlate them to specific surgical needs, to simplify the surgical choice and patient management.

Ex Vivo Functional Benchmarking of Hyaluronan-Based Osteoarthritis Viscosupplement Products: Comprehensive Assessment of Rheological, Lubricative, Adhesive, and Stability Attributes.

While many injectable viscosupplementation products are available for osteoarthritis (OA) management, multiple hydrogel functional attributes may be further optimized for efficacy enhancement. The objective of this study was to functionally benchmark four commercially available hyaluronan-based viscosupplements (Ostenil, Ostenil Plus, Synvisc, and Innoryos), focusing on critical (rheological, lubricative, adhesive, and stability) attributes. Therefore, in vitro and ex vivo quantitative characterization panels (oscillatory rheology, rotational tribology, and texture analysis with bovine cartilage) were used for hydrogel product functional benchmarking, using equine synovial fluid as a biological control.

Autologous and Allogeneic Cytotherapies for Large Knee (Osteo)Chondral Defects: Manufacturing Process Benchmarking and Parallel Functional Qualification.

Cytotherapies are often necessary for the management of symptomatic large knee (osteo)-chondral defects. While autologous chondrocyte implantation (ACI) has been clinically used for 30 years, allogeneic cells (clinical-grade FE002 primary chondroprogenitors) have been investigated in translational settings (Swiss progenitor cell transplantation program). The aim of this study was to comparatively assess autologous and allogeneic approaches (quality, safety, functional attributes) to cell-based knee chondrotherapies developed for clinical use.

Cutaneous Cell Therapy Manufacturing Timeframe Rationalization: Allogeneic Off-the-Freezer Fibroblasts for Dermo-Epidermal Combined Preparations (DE-FE002-SK2) in Burn Care.

Autologous cell therapy manufacturing timeframes constitute bottlenecks in clinical management pathways of severe burn patients. While effective temporary wound coverings exist for high-TBSA burns, any means to shorten the time-to-treatment with cytotherapeutic skin grafts could provide substantial therapeutic benefits. This study aimed to establish proofs-of-concept for a novel combinational cytotherapeutic construct (autologous/allogeneic DE-FE002-SK2 full dermo-epidermal graft) designed for significant cutaneous cell therapy manufacturing timeframe rationalization.

Bio-Enhanced Neoligaments Graft Bearing FE002 Primary Progenitor Tenocytes: Allogeneic Tissue Engineering & Surgical Proofs-of-Concept for Hand Ligament Regenerative Medicine.

Hand tendon/ligament structural ruptures (tears, lacerations) often require surgical reconstruction and grafting, for the restauration of finger mechanical functions. Clinical-grade human primary progenitor tenocytes (FE002 cryopreserved progenitor cell source) have been previously proposed for diversified therapeutic uses within allogeneic tissue engineering and regenerative medicine applications. The aim of this study was to establish bioengineering and surgical proofs-of-concept for an artificial graft (Neoligaments Infinity-Lock 3 device) bearing cultured and viable FE002 primary progenitor tenocytes.

Thermo-Responsive Hyaluronan-Based Hydrogels Combined with Allogeneic Cytotherapeutics for the Treatment of Osteoarthritis.

Thermo-responsive hyaluronan-based hydrogels and FE002 human primary chondroprogenitor cell sources have both been previously proposed as modern therapeutic options for the management of osteoarthritis (OA). For the translational development of a potential orthopedic combination product based on both technologies, respective technical aspects required further optimization phases (e.g.

A New Ex Vivo Human Skin Burn Model.

Currently, most burn models for preclinical testing are on animals. For obvious ethical, anatomical, and physiological reasons, these models could be replaced with optimized ex vivo systems. The creation of a burn model on human skin using a pulsed dye laser could represent a relevant model for preclinical research.

Process Optimization and Efficacy Assessment of Standardized PRP for Tendinopathies in Sports Medicine: Retrospective Study of Clinical Files and GMP Manufacturing Records in a Swiss University Hospital.

Platelet-rich plasma (PRP) preparations have recently become widely available in sports medicine, facilitating their use in regenerative therapy for ligament and tendon affections. Quality-oriented regulatory constraints for PRP manufacturing and available clinical experiences have underlined the critical importance of process-based standardization, a pre-requisite for sound and homogeneous clinical efficacy evaluation. This retrospective study (2013-2020) considered the standardized GMP manufacturing and sports medicine-related clinical use of autologous PRP for tendinopathies at the Lausanne University Hospital (Lausanne, Switzerland).

Current Status of PRP Manufacturing Requirements & European Regulatory Frameworks: Practical Tools for the Appropriate Implementation of PRP Therapies in Musculoskeletal Regenerative Medicine.

Providing accurate and up-to-date practical tools enabling oversight of platelet-rich plasma (PRP) legislation and of the appropriate standards to be implemented for its manufacture and use in Europe is a demanding task. This is due to rapid medico-technological advancements, slowness and disparity in legislation updates and enforcement between member states, and many reported gray-zone practices, notably for autologous PRP use. The levels of risk associated with blood manipulation processes generally dictate the manufacturing requirements for PRP preparations, which have gradually shifted toward good manufacturing practices (GMP) for standardization and overall quality enhancement.

Industrial Biotechnology Conservation Processes: Similarities with Natural Long-Term Preservation of Biological Organisms.

Cryopreservation and lyophilization processes are widely used for conservation purposes in the pharmaceutical, biotechnological, and food industries or in medical transplantation. Such processes deal with extremely low temperatures (e.g.

Isolation and Culture of Human Adipose-Derived Stem Cells With an Innovative Xenogeneic-Free Method for Human Therapy.

Considering the increasing impact of stem cell therapy, biosafety concerns have been raised regarding potential contamination or infection transmission due to the introduction of animal-derived products during in vitro manipulation. The xenogeneic components, such as collagenase or fetal bovine serum, commonly used during the cell isolation and expansion steps could be associated with the potential risks of immune reactivity or viral, bacterial, and prion infection in the receiving patients. Following good manufacturing practice guidelines, chemical tissue dissociation should be avoided, while fetal bovine serum (FBS) can be substituted with xenogeneic-free supplements.

Lower limb soft tissue reconstruction using free ALT flaps: multimodal parameter analysis to predict the level of spontaneous reinnervation.

Introduction: This work aims to assess lower limb free flaps spontaneous sensory recovery by comparing and analyzing a single standardized reconstructive procedure, namely the free noninnervated anterolateral thigh (ALT) flap in order to evaluate which flap or patient-related factors may predict flap reinnervation.

Methods: Between January 2010 and March 2018 all nonreinnervated ALT flaps for lower limb coverage performed at our institution were screened. We excluded from the study flaps with less than 18 months of follow-up time, neurotized flaps, and those from patients who missed the last follow up.

Retrospectives on Three Decades of Safe Clinical Experience with Allogeneic Dermal Progenitor Fibroblasts: High Versatility in Topical Cytotherapeutic Care.

Allogeneic dermal progenitor fibroblasts constitute cytotherapeutic contenders for modern cutaneous regenerative medicine. Based on advancements in the relevant scientific, technical, and regulatory fields, translational developments have slowly yet steadily led to the clinical application of such biologicals and derivatives. To set the appropriate general context, the first aim of this study was to provide a current global overview of approved cell and gene therapy products, with an emphasis on cytotherapies for cutaneous application.

Lyophilized Progenitor Tenocyte Extracts: Sterilizable Cytotherapeutic Derivatives with Antioxidant Properties and Hyaluronan Hydrogel Functionalization Effects.

Cultured primary progenitor tenocytes in lyophilized form were previously shown to possess intrinsic antioxidant properties and hyaluronan-based hydrogel viscosity-modulating effects in vitro. The aim of this study was to prepare and functionally characterize several stabilized (lyophilized) cell-free progenitor tenocyte extracts for inclusion in cytotherapy-inspired complex injectable preparations. Fractionation and sterilization methods were included in specific biotechnological manufacturing workflows of such extracts.

Pressure sore incidence and treatment in left ventricular assist device (LVAD)-equipped patients: Insights from a prospective series.

Introduction: A left ventricular assistance device (LVAD) is indicated in patients with end-stage heart failure. Due to the non-physiologic blood flow, a LVAD may favor pressure sores with a devastating risk of infection. This work shows the prevalence and treatment of pressure sores in LVAD patients, to optimize their management.

Breast Reconstruction: Economic Impact Swiss Health Insurance System.

Background: Considering present concerns about healthcare costs and the lack of evidence and published articles on breast reconstruction costs in Switzerland, we retrospectively investigated charges to the Swiss healthcare system for different breast reconstruction procedures at the Centre Hospitalier Universitaire Vaudois.

Methods: We selected all hospitalized patients at the University Hospital who underwent a "total" delayed breast reconstruction from January 2012 to December 2015. Analysis included 72 women who underwent autologous or implant-based reconstructions.

Body Composition Assessment by Dual-Energy X-Ray Absorptiometry: A Useful Tool for the Diagnosis of Lipedema.

Introduction: Lipedema is a poorly known condition. Diagnosis is based almost exclusively on clinical criteria, which may be subjective and not always reliable. This study aimed to investigate regional body composition (BC) by dual-energy X-ray absorptiometry (DXA) in patients with lipedema and healthy controls and to determine cut-off values of fat mass (FM) indices to provide an additional tool for the diagnosis and staging of this condition.

Upper airway obstruction following radiofrequency-assisted liposuction of the neck and lower face: a case report.

Radiofrequency-assisted liposuction (RFAL) recently gained popularity for non-excisional skin tightening. It involves the delivery of a controlled amount of energy resulting in fat liquefaction and skin contraction. It is regarded as safe and effective.

Quality of life and sexual health after perineal reconstruction in Fournier gangrene using pedicled anterolateral thigh flaps.

Objectives: To assess long-term sexual outcome and quality of life after perineal reconstruction by pedicled anterolateral thigh (ALT) flaps after Fournier's gangrene. Postoperative surgical outcomes were assessed; quality of life and sexual function were assessed at long term follow-up (>12 months) with 2 scientifically validated questionnaires.

Methods: We conducted a retrospective analysis of a prospectively maintained database.

Impact of etiology leading to abdominoperineal resection with anterolateral thigh flap reconstruction: A retrospective cohort study.

Background: Large and deep perineal defects following abdominal perineal resection (APR) are a challenge for reconstructive surgeons. Even if generally performed for oncological reasons, APR can be indicated as well in extended infection-related debridement for Hidradenitis suppurativa, Fournier's gangrene, or Crohn's disease. We aimed to compare the outcomes of two groups of patients with different indications for APR (infectious vs.

Facial Fat Grafting (FFG): Worth the Risk? A Systematic Review of Complications and Critical Appraisal.

Autologous fat is ideal soft tissue filler. It is easily accessible, biocompatible, cheap, and it provides both volume augmentation and skin quality improvement. Fat grafting has been used since 1893, but it has only gained widespread popularity since the development of modern liposuction by Colemann and Illouz in the 1980s.