A phase 3b, open-label, single-arm, multicenter, expanded-access study of the safety and clinical outcomes of StrataGraft® treatment in adults with deep partial-thickness thermal burns.

Background: A phase 3b, open-label, multicenter, expanded-access study (NCT04123548) evaluated safety and clinical outcomes of StrataGraft treatment in adults with deep partial-thickness thermal burns with intact dermal elements.

Methods: Adult patients with 3 % to < 50 % total body surface area burns were treated with a single application of ≤ 1:1 meshed StrataGraft and followed for 24 weeks. Primary endpoint was count and percentage of patients with treatment-emergent adverse events (TEAEs).

A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft® construct in patients with deep partial-thickness thermal burns.

Objective: This phase 3 study evaluated StrataGraft construct as a donor-site sparing alternative to autograft in patients with deep partial-thickness (DPT) burns.

Methods: Patients aged ≥18 years with 3-49% total body surface area (TBSA) thermal burns were enrolled. In each patient, 2 DPT areas (≤2000cm total) of comparable depth after excision were randomized to either cryopreserved StrataGraft or autograft.

Determining clinically meaningful thresholds for innovative burn care products to reduce autograft: A US burn surgeon Delphi panel.

Reducing the amount of donor skin needed for definitive wound closure can improve outcomes in patients with severe burns. This Delphi Consensus Panel (DCP) aimed to achieve expert consensus on the percentage reduction in donor skin for autograft that constitutes a clinically meaningful benefit. A two-round DCP of fifteen US burn surgeons was conducted via a web-based survey platform.

Navigating the Regulatory Pathways and Requirements for Tissue-Engineered Products in the Treatment of Burns in the United States.

In the burn treatment landscape, a variety of skin substitutes, human tissue-sourced products, and other products are being developed based on tissue engineering (ie, the combination of scaffolds, cells, and biologically active molecules into functional tissue with the goal of restoring, maintaining, or improving damaged tissue or whole organs) to provide dermal replacement, prevent infection, or prevent or mitigate scarring. Skin substitutes can have a variety of compositions (cellular vs acellular), origins (human, animal, or synthetically derived), and complexities (dermal or epidermal only vs composite). The regulation of tissue-engineered products in the United States occurs by one of several pathways established by the U.

Healthcare resource utilization, treatment patterns, and cost of care among patients with thermal burns and inpatient autografting in two large privately insured populations in the United States.

The current standard of care for severe burns includes autografting; however, there is scarce knowledge regarding the long-term economic burden associated with thermal burns and inpatient autografting. The objective of this study was to characterize healthcare resource utilization, treatment patterns, and cost of care for thermal burn patients in two large privately insured populations in the United States who underwent inpatient autografting between 01/01/2011 and 06/30/2016. Patient demographics, clinical characteristics, healthcare resource utilization, and total cost were examined during baseline (one year before the initial hospitalization with autografting) and two-year evaluation period.

Modulation of Cell Attachment, Proliferation, and Angiogenesis by Decellularized, Dehydrated Human Amniotic Membrane in In Vitro Models.

Background: Decellularized, dehydrated human amniotic membrane (DDHAM) is an extracellular matrix devoid of cells, cell debris, and growth factors. This study examines the effect of cell attachment to the DDHAM and the induced cellular responses.

Materials And Methods: The cell types employed in this study were human dermal fibroblasts (HDF), human epithelial keratinocytes (HEK), and human dermal microvascular endothelial cells (HDMEC), all of which play critical roles in the wound healing process.

Real-world Experience With a Decellularized Dehydrated Human Amniotic Membrane Allograft.

Unlabelled: While randomized controlled trials (RCTs) are designed to evaluate efficacy and/or safety under controlled conditions, use of strict inclusion/ exclusion criteria are noted to exclude more than 50% of wound populations. Applicability of RCT outcomes to performance expectations in real-world wound populations raises questions about generalizing their results. The primary aim of this decellularized, dehydrated human amniotic membrane (DDHAM) Use Registry Study was to gain experience and observe outcomes with use of a DDHAM in uninfected, full-thickness, or partial-thickness wounds that, in the investigators' opinions, would benefit from such treatment.

The detection of anti-erythropoietin antibodies in human serum and plasma. Part I. Validation of the protocol for a radioimmunoprecipitation assay.

Rare cases of unexplained sudden severe anemia or red cell aplasia and resistance to recombinant human erythropoietin (rHuEPO) in patients with chronic renal failure (CRF) have been attributed to the development of anti-EPO antibodies. The development and validation of a radioimmunoprecipitation (RIP) assay to detect human anti-EPO antibodies in serum or plasma has been hampered by the lack of purified antibody to fully characterize and validate the assay. We have prepared an affinity-purified human antibody to EPO and used the antibody to characterize and validate a sensitive and reproducible RIP assay that can qualitatively measure anti-EPO antibody in serum or plasma samples.

A meta-analytic approach to an integrated summary of efficacy: a case study of becaplermin gel.

This paper presents a case study involving a meta-analytic approach for an integrated summary of efficacy based upon four phase II and III clinical trials that comprised the basis for a Biologics License Application to the U.S. Food and Drug Administration for approval of becaplermin gel.