Cellular and/or Tissued-Based Products

Wound repair and regeneration comprise a complex process of biological and molecular events that consists of cell migration and proliferation, along with extracellular matrix deposition and remodeling. Unfortunately, not all wounds progress through healing easily. Certain pathophysiologic and metabolic conditions can alter the course of healing and impair or delay it, resulting in chronic, nonhealing wounds. The costs to treat nonhealing wounds can be high, and the patient’s quality of life can be impacted by any related loss of mobility or productivity. For these reasons, advanced wound care modalities and products may be introduced to help address underlying factors that impair the healing process.

By Industry News

Miami, FL – June 1, 2020 – Amniox Medical, Inc. (Amniox), a TissueTech, Inc. company, announced today the results from the one-year follow-up study to their Phase 2 open label, multicenter pilot study of Cryopreserved Umbilical Cord allograft TTAX01. The objectives of the study were to examine the safety and efficacy of TTAX01, plus standard of care, in achieving complete wound closure of complex non-healing Diabetic Foot Ulcers (DFUs) with evidence of exposed bone, tendon, muscle and/or joint capsule and clinical suspicion of osteomyelitis. Results of this one-year study are published in the peer-reviewed journal Wound Repair and Regeneration.

By the WoundSource Editors

Wound reepithelialization is key in the goal of wound closure. Reepithelialization is a coordinated multifactorial systemic process that involves formation of new epithelium and skin appendages. The epithelialization process can be stalled by a number of factors, all of which must be resolved before wound healing can move forward.

By Thomas E. Serena MD, FACS, FACHM, FAPWCA

Editor's note:This blog post is part of the WoundSource Trending Topics series, bringing you insight into the latest clinical issues and advancement in wound management, with contributions by the WoundSource Editorial Advisory Board.

Temple University School of Podiatric Medicine Journal Review Club
Editor's note: This post is part of the Temple University School of Podiatric Medicine (TUSPM) journal review club blog series. In each blog post, a TUSPM student will review a journal article relevant to wound management and related topics and provide their evaluation of the clinical research therein.

Temple University School of Podiatric Medicine Journal Review Club
Editor's note: This post is part of the Temple University School of Podiatric Medicine (TUSPM) journal review club blog series. In each blog post, a TUSPM student will review a journal article relevant to wound management and related topics and provide their evaluation of the clinical research therein.

Marietta, GA – October 11, 2017 – MiMedx Group, Inc. (NASDAQ: MDXG), a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the latest peer-reviewed clinical study of MiMedx dehydrated human amnion/chorion membrane ("dHACM") allografts has been published in the International Wound Journal.

Temple University School of Podiatric Medicine Journal Review Club
Editor's note: This post is part of the Temple University School of Podiatric Medicine (TUSPM) journal review club blog series. In each blog post, a TUSPM student will review a journal article relevant to wound management and related topics and provide their evaluation of the clinical research therein.

By the WoundSource Editors

Silver Spring – September 6th, 2017 – The final guidance, Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271," explains when it is necessary for manufacturers of certain human cells, tissues, and cellular and tissue-based products (HCT/Ps), which do not require FDA premarket review and approval, to report to the agency when infectious disease testing or determination of other donor eligibility criteria have not been performed properly. While this is not a new requirement, the final guidance seeks to provide greater clarity to industry on how to properly follow the regulations already in effect. Specifically, the FDA is issuing this guidance to provide establishments that manufacture non-reproductive HCT/Ps with specific recommendations and relevant examples for complying with the applicable requirements to investigate and report HCT/P deviations to the FDA.

Temple University School of Podiatric Medicine Journal Review Club
Editor's note: This post is part of the Temple University School of Podiatric Medicine (TUSPM) journal review club blog series. In each blog post, a TUSPM student will review a journal article relevant to wound management and related topics and provide their evaluation of the clinical research therein.