Clinical Publications
“Prospective, Randomized, Blinded, Comparative Study of Injectable Micronized Dehydrated Amniotic/Chorionic Membrane Allograft for Plantar Fasciitis—A Feasibility Study”
Charles M. Zelen, DPM, Attila Poka, MD, and James Andrews, MDFoot & Ankle International, ePub August 2013The randomized clinical trial examined the efficacy of dehydrated human amnion/chorion membrane (dHACM) injection as a treatment for the inflammation associated with chronic refractory plantar fasciitis. The study determined that this injection for plantar fasciitis can reduce inflammation and promote healing and may be an alternative to surgical intervention.
"Biological Properties of Dehydrated Human Amnion/Chorion Grafts: Implications for Chronic Wound Healing"
Thomas J Koob, Robert Rennert, Nicole Zabek, Michelle Massee, Jeremy J Lim, Johnna S Temenoff, William W Li, Geoffrey GurtnerInternational Wound JournalArticle first published online: 1 AUG 2013DOI: 10.1111/iwj.12140EpiFix® was evaluated for the presence of growth factors, interleukins (ILs) and tissue inhibitors (TIMPs) of enzymes that degrade the extracellular matrix, or metalloproteinases. Both in vitro and in vivo experiments were conducted, and it was clearly established that:
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PURION® processed dHACM retains biologically active growth factors and regulatory factors that are at least partially responsible for its clinical effectiveness in wound healing;
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dHACM contains one or more soluble factors that stimulate mesenchymal stem cell (MSC) migration and recruitment; and
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dHACM is a multifaceted tissue graft that has the potential to positively affect at least four distinct physiological processes: cell proliferation, inflammation, metalloproteinase activity, and recruitment of stem cells – all of which are integral to regenerative wound healing and soft tissue repair.
"Scientific and Clinical Support for the Use of Dehydrated Amniotic Membrane in Wound Management"
Donald E. Fetterolf, MD and Robert J. Snyder, DPM, MScWOUNDS 2012;24(10):299–307Details the history of amniotic membrane use in clinical applications and new techniques for dehydrating the material while preserving the structural components and key elements contained within the amniotic membrane important for wound healing.
"Dehydrated Human Amniotic Membrane Allograft Nerve Wrap Around the Prostatic Neurovascular Bundle Accelerates Early Return to Continence and Potency Following Robot-assisted Radical Prostatectomy: Propensity Score–matched Analysis"
Vipul R. Patel , Srinivas Samavedi, Anthony S. Bates, Anup Kumar, Rafael Coelho, Bernardo Rocco and Kenneth Palmer S0302-2838(15)00027-5
DOI: 10.1016/j.eururo.2015.01.012
In this feasibility study, dehydrated human amniotic membrane was placed around the neurovascular bundle of the prostate following full nerve-sparing robotic prostatectomy. A greater proportion of patients receiving the treatment returned to full continence and potency earlier compared to patients who did not receive the grafted tissue. Use of an allograft of dehydrated human amniotic membrane hastened the return of continence and potency in patients following robot-assisted radicalprostatectomy.
"Protective patch linked to erectile function recovery".
90% of patients receiving membrane during robotic RP regain function at 3 months
The study examined 60 patients who underwent surgery for low-volume prostate cancer. Of 22 men receiving an AmnioFix (MiMedx, Marietta, GA) dHAM during a bilateral nerve-sparing procedure, 20 (90.9%) demonstrated a return of erectile function at 3 months, and 21 men (95.5%) recovered function at 6 months. In 38 men undergoing the same procedure but without the dHAM, 16 (42.1%) recovered erectile function at 3 months and 20 (52.6%) at 6 months (p=.0005 at 3 months and ≤.0002 at 6 months for the cohort comparisons).
"Cytokines in single layer amnion allografts compared to multilayer amnion/chorion allografts for wound healing"
"Human amniotic membrane is comprised of two distinct but conjoined tissues, amnion and chorion, both derived from the inner layer of the placenta. The amnion faces the fetus and the chorion faces the uterus. The amnion consists of a layer of epithelial cells anchored to a basement membrane that is underlain by a compact, collagen-rich tissue. The chorion is comprised primarily of dense collagen fibers in an interfibrillar matrix containing proteoglycans and elastic fibers. Cells are distributed throughout the amniotic membrane. Neither the amnion nor chorion is vascularized. The amniotic membrane is a metabolically active tissue that continually remodels and grows to accommodate the growing conceptus. Remodeling of the tissue is governed by growth factors, cytokines, chemokines, and related regulatory factors produced by the endogenous cells in the amniotic membrane."
"Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing"
"The molecular mechanisms responsible for chronic wound formation remain poorly understood, partly because wound healing involves a well-coordinated sequence of complex and interrelated physiological processes, including inflammation, angiogenesis, cell-mediated regeneration of the vasculature and extracellular matrix, and epithelialization. The failure to heal of chronic wounds could be the result of deficiencies in one or any combination of these processes. This is exemplified by the pathological conditions in which chronic wounds develop, such as diabetic neuropathic ulcers, chronic venous insufficiencies, pressure ulcers and arterial disease. Targeting therapies for a single process within this sequence of events, such as a single growth factor that affects one aspect of angiogenesis or is limited to promoting extracellular matrix production, is unlikely to achieve full tissue regeneration and wound closure. A multifaceted therapy that addresses multiple defective physiological processes and revitalises the cascade of normal reparative mechanisms is clearly needed."