Grafix (cryopreserved placental membrane) / Osiris - LARVOL DELTA

Unveiling Gender Disparities: Female Authorship in Pivotal Trials for US Food and Drug Administration (FDA)-Approved Novel Chimeric Antigen Receptor T-Cell Therapies (ASH 2023) - "The gender of trial authors was captured as binary (women and men) and was identified by using the Genderize software (Demografix ApS) or by verifying personal pronouns on authors' institutional profiles or other sources...ConclusionsOur study highlights gender disparities in the authorship of pivotal efficacy trials supporting the FDA approval of novel CAR-T cell therapies. This underscores the urgent need for institutions to devise tailored policies that tackle the unique challenges faced by women in the medical field, while fostering an inclusive and supportive workplace environment that empowers women to achieve academic success."

CAR T-Cell Therapy • Hematological Malignancies • Oncology

Comparative effectiveness of porcine placental extracellular matrix against other cellular, acellular and matrix-like products in diabetic foot ulcers from the Medicare database. (PubMed, J Comp Eff Res) - "Eligible patients were categorized into groups according to treatment received: PPECM, PPECM's 510(k) predicate† (OASIS® Wound Matrix, Cook Biotech Inc., IN, USA), or other similar CAMPs (OSC [Marigen Shield and Omega3 (Kerecis, Ísafjörður, Iceland); Integra Dermal Regeneration Template and Primatrix (Integra LifeSciences, NJ, USA); GraftJacket (Stryker, MI, USA); Theraskin and Dermacell (LifeNet Health, VA, USA); FlexHD/AllopatchHD and Amnioband (MTF Biologics, NJ, USA); Grafix/Stravix (Smith + Nephew, MA, USA); Epicord and Epifix (MiMedx, GA, USA); Affinity, Apligraf and Dermagraft (Organogenesis, MA, USA)]). Notably, episodes of DFU care that involved PPECM were associated with significantly fewer outpatient amputations, fewer episodes of bacteremia, and fewer outpatient hospital visits. These data suggest that PPECM offers a clinically competitive treatment option for patients with DFUs."

HEOR • Journal • Medicare • Preclinical • Reimbursement • US reimbursement • Diabetes • Metabolic Disorders

A Multicenter, Randomized, Controlled, Clinical Trial Evaluating a Lyopreserved Amniotic Membrane in the Treatment of Venous Leg Ulcers. (PubMed, Health Sci Rep) - P=N/A | "Trial Registration: ClinicalTrials.gov ID: NCT03629236, Study to Evaluate Safety and Efficacy of GrafixPL for the Treatment of Venous Leg Ulcers. (https://clinicaltrials.gov/study/NCT03629236)."

Journal • Venous Ulcer

Evaluation of Representation of Women As Authors in Pivotal Trials Supporting US Food and Drug Administration Approval of Novel Hematological Drugs (ASH 2022) - "The gender of trial authors was captured as binary (women and men) and was identified by using the Genderize software (Demografix ApS) or by verifying personal pronouns on authors' institutional profiles or other sources...Conclusion Our study demonstrates gender inequity in authorship of pivotal efficacy trials supporting approval of novel Hematological drugs by the FDA. Institutions should devise targeted policies addressing unique challenges faced by women in medicine and develop a workplace environment conducive to women's academic success."

Clinical • FDA event • Hematological Disorders

Human amniotic membrane products for patients with diabetic foot ulcers. do they help? a systematic review and meta-analysis. (PubMed, J Foot Ankle Res) - "Using DHACA with SOC is safer and more effective than using SOC alone for DFU patients."

Clinical • Journal • Retrospective data • Review • Diabetes • Pain

"PT Grafix but also ASAHI Gladius MG works perfectly in these situations. You need a very soft shapeable tip :-)" (@LorenzoPatrone3)

Study to Evaluate Safety and Efficacy of GrafixPL for the Treatment of Venous Leg Ulcers (clinicaltrials.gov) - P=N/A | N=200 | Completed | Sponsor: Osiris Therapeutics | Active, not recruiting ➔ Completed | Trial completion date: Jan 2021 ➔ Jun 2021 | Trial primary completion date: Oct 2020 ➔ Jun 2021

Trial completion • Trial completion date • Trial primary completion date • Venous Ulcer

Structural implications for a phycobilisome complex from the thermophilic cyanobacterium Thermosynechococcus vulcanus. (PubMed, Biochim Biophys Acta Bioenerg) - "In addition, there are eight PC rods in the PBS: one bottom pair (Rb and Rb'), one top pair (Rt and Rt'), and two side pairs (Rs1/Rs1' and Rs2/Rs2'). Comparison with the overall structures of PBSs from other organisms revealed structural characteristics of T. vulcanus PBS."

Journal

Utilization of Grafix for the Detection of Transient Interactors of Saccharomyces cerevisiae Spliceosome Subcomplexes. (PubMed, J Vis Exp) - "This method is based on the centrifugation of samples into an increasing concentration of a fixation reagent to stabilize complexes. After centrifugation of yeast total extracts loaded on glycerol gradients, recovered fractions are analyzed by dot blot for the identification of the spliceosome sub-complexes and determination of the presence of individual splicing factors."

Journal

GrafixPL PRIME Evaluation Case Study (clinicaltrials.gov) - P4; N=40; Completed; Sponsor: University of Texas Southwestern Medical Center; Active, not recruiting ➔ Completed

Clinical • Trial completion

AgarFix: simple and accessible stabilization of challenging single-particle cryo-EM specimens through crosslinking in a matrix of agar. (PubMed, J Struct Biol) - "Gradient-based crosslinking through the GraFix method is more robust, but very time-consuming and necessitates specialised expensive equipment...The sample is recovered by diffusion or electroelution and can readily be used for cryo-EM specimen preparation. AgarFix requires minimal equipment and basic lab experience, making it widely accessible to the cryo-EM community."

Journal

Study to Evaluate Safety and Efficacy of GrafixPL for the Treatment of Venous Leg Ulcers (clinicaltrials.gov) - P=N/A; N=200; Active, not recruiting; Sponsor: Osiris Therapeutics; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Cardiovascular • Varicose Veins • Venous Ulcer

Prospective study of cryopreserved placental tissue wound matrix in the management of chronic venous leg ulcers. (PubMed, J Vasc Surg Venous Lymphat Disord) - "Cryopreserved placental tissue (hVWM) improves healing processes to achieve complete wound closure in a significant proportion of chronic VLUs refractory to standard therapy. Adjunctive therapy with hVWM provides superior healing rates in refractory VLUs."

Clinical • Journal

GrafixPL PRIME Evaluation Case Study (clinicaltrials.gov) - P4; N=40; Active, not recruiting; Sponsor: University of Texas Southwestern Medical Center; Recruiting ➔ Active, not recruiting; Trial primary completion date: Nov 2019 ➔ Mar 2020

Clinical • Enrollment closed • Trial primary completion date

COST ANALYSIS COMPARING TWO HUMAN ALLOGRAFTS IN HEALING DIABETIC FOOT ULCERS OVER A 16 WEEK PERIOD (ISPOR 2019) - "... Matched diabetic patients from 2 published studies, based on comorbidities , age, sex, wound size, and wound location were evaluated over a 16-week period for complete diabetic foot ulcer (DFU) closure defined as (100%) re-epithelialization (healing) in using both cryopreserved umbilical cord (Neox) and human placental membrane (Grafix)... In complex DFUs with exposed tendon, muscle or bone, the use of Neox was the less costly option to attain higher wound closure rates over the same time period. This was due to the fact that fewer Neox product applications were required. Prospective randomized controlled trials or manufacturer sponsored registries might be considered in order to verify these early results for this serious condition and unmet medical need."

HEOR