Abstract

Progenitor Biological Bandages (PBB) have been continuously applied clinically in the Lausanne Burn Center for over two decades. Vast translational experience and hindsight have been gathered, specifically for cutaneous healing promotion of donor-site grafts and second-degree pediatric burns. PBBs constitute combined Advanced Therapy Medicinal Products, containing viable cultured allogeneic fetal dermal progenitor fibroblasts. Such constructs may partly favor repair and regeneration of functional cutaneous tissues by releasing cytokines and growth factors, potentially negating the need for subsequent skin grafting, while reducing the formation of hypertrophic scar tissues. This retrospective case-control study (2010–2018) of pediatric second-degree burn patients comprehensively compared two initial wound treatment options (i.e., PBBs versus Aquacel® Ag, applied during ten to twelve days post-trauma). Results confirmed clinical safety of PBBs with regard to morbidity, mortality, and overall complications. No difference was detected between groups for length of hospitalization or initial relative burn surface decreasing rates. Nevertheless, a trend was observed in younger patients treated with PBBs, requiring fewer corrective interventions or subsequent skin grafting. Importantly, significant improvements were observed in the PBB group regarding hypertrophic scarring (i.e., reduced number of scar complications and related corrective interventions). Such results establish evidence of clinical benefits yielded by the Swiss fetal progenitor cell transplantation program and favor further implementation of specific cell therapies in highly specialized regenerative medicine.

Highlights

  • Vast translational clinical experience and hindsight have been gathered around the therapeutic use of Progenitor Biological Bandages (PBB) in the Lausanne University Hospital Burn Center over the past two decades [1,2,3,4,5,6]

  • And appropriate wound coverage with standard specific bandages (e.g., DuoDERM®, Kaltostat®, Polymem®, Mepitel® Ag, Aquacel® Ag) and creams (e.g., Ialugen Plus® ) is possible to a certain extent, but relatively large or deep wounds reaching into the dermis and underlying tissues necessitate advanced coverage solutions, to limit the long-term impact of traumatic cutaneous injuries on the lives of young children [39]

  • And late primary outcomes for the presented retrospective study comprised closure kinetics of burn wounds depending on the surface and severity thereof, need for skin grafting and surface of grafted wounds, number of PBB applications, treatment-related complications, complications unrelated to treatment, length of hospital stay, need for scar management and modalities/duration thereof

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Summary

Introduction

Vast translational clinical experience and hindsight have been gathered around the therapeutic use of Progenitor Biological Bandages (PBB) in the Lausanne University Hospital Burn Center over the past two decades [1,2,3,4,5,6]. Pediatric burn patient populations have constituted the primary beneficiaries of this form of cultured allogeneic fetal progenitor cell (FPC) therapy, initially implemented as a temporary coverage solution for skin autograft donor-sites and second-degree thermal cutaneous wounds [1,2]. Standardized transplants, as they are constituted by collagen sheet-scaffolds yielding cultured primary fetal dermal progenitor fibroblasts. Such bioengineered constructs may partly favor repair and regeneration of functional cutaneous tissues in burn victims by releasing cytokines and growth factors, potentially negating the need for subsequent skin grafting, while reducing the formation of hypertrophic scar tissues [4,6,9]. Constituting a singularity, the Swiss FPC transplantation program, enabling the inception and continued clinical supply of PBBs, was devised for a holistic and sustainable control of therapeutic material generation and manufacturing under current Good Manufacturing

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