Grafix (cryopreserved placental membrane) / Osiris 
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 29 Diseases   4 Trials   4 Trials   37 News 
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    Evaluation of Representation of Women As Authors in Pivotal Trials Supporting US Food and Drug Administration Approval of Novel Hematological Drugs (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_6679;    
    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.
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    Trial completion, Trial completion date, Trial primary completion date:  Study to Evaluate Safety and Efficacy of GrafixPL for the Treatment of Venous Leg Ulcers (clinicaltrials.gov) -  Apr 12, 2022   
    P=N/A,  N=200, Completed, 
    Using DHACA with SOC is safer and more effective than using SOC alone for DFU patients. Active, not recruiting --> Completed | Trial completion date: Jan 2021 --> Jun 2021 | Trial primary completion date: Oct 2020 --> Jun 2021
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    Journal:  Utilization of Grafix for the Detection of Transient Interactors of Saccharomyces cerevisiae Spliceosome Subcomplexes. (Pubmed Central) -  Dec 30, 2020   
    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.
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    Trial completion:  GrafixPL PRIME Evaluation Case Study (clinicaltrials.gov) -  Aug 8, 2020   
    P4,  N=40, Completed, 
    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. Active, not recruiting --> Completed
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    Enrollment closed:  Study to Evaluate Safety and Efficacy of GrafixPL for the Treatment of Venous Leg Ulcers (clinicaltrials.gov) -  Apr 17, 2020   
    P=N/A,  N=200, Active, not recruiting, 
    AgarFix requires minimal equipment and basic lab experience, making it widely accessible to the cryo-EM community. Recruiting --> Active, not recruiting
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    Enrollment closed, Trial primary completion date:  GrafixPL PRIME Evaluation Case Study (clinicaltrials.gov) -  Jan 18, 2020   
    P4,  N=40, Active, not recruiting, 
    Adjunctive therapy with hVWM provides superior healing rates in refractory VLUs. Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2019 --> Mar 2020
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    New P4 trial:  GrafixPL PRIME Evaluation Case Study (clinicaltrials.gov) -  Nov 15, 2018   
    P4,  N=40, Recruiting, 
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    New trial:  Evaluating the Safety and Efficacy of GrafixPL (clinicaltrials.gov) -  Jun 2, 2018   
    P=N/A,  N=30, Not yet recruiting, 
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    Trial completion:  GrafixPRIME (clinicaltrials.gov) -  Jul 17, 2017   
    P4,  N=75, Completed, 
    These results corroborate the benefits of this CPM combined with SWC over SWC alone for chronic DFUs previously reported for the blinded randomized phase of the trial, which directly relate to lower health care costs. Recruiting --> Completed
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    Trial primary completion date:  GrafixPRIME (clinicaltrials.gov) -  Apr 5, 2017   
    P4,  N=74, Recruiting, 
    Recruiting --> Completed Trial primary completion date: Nov 2016 --> Jun 2017
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    New trial, Real-world evidence, Real-world:  VLUR: Venous Leg Ulcer and Lymphedema Registry (clinicaltrials.gov) -  Jun 24, 2016   
    P=N/A,  N=10000, Enrolling by invitation, 
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    New P4 trial:  GrafixPRIME (clinicaltrials.gov) -  Feb 5, 2016   
    P4,  N=74, Recruiting, 
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    Trial completion, Enrollment change:  GrafixCORE (clinicaltrials.gov) -  Feb 2, 2016   
    P4,  N=31, Completed, 
    Trial primary completion date: Nov 2016 --> Jun 2017 Recruiting --> Completed | N=40 --> 31
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    Trial primary completion date:  CTPR: Cellular and Tissue Based Therapy Registry (clinicaltrials.gov) -  Jun 11, 2015   
    P=N/A,  N=50000, Recruiting, 
    Recruiting --> Completed | N=40 --> 31 Trial primary completion date: Jan 2015 --> Jan 2020
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    New P4 trial:  GrafixCORE (clinicaltrials.gov) -  Oct 10, 2014   
    P4,  N=40, Recruiting, 
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    Enrollment change:  Grafix (clinicaltrials.gov) -  Apr 6, 2014   
    P4,  N=97, Completed, 
    Trial primary completion date: Jan 2015 --> Jan 2020 N=266 --> 97
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    Trial completion:  Grafix (clinicaltrials.gov) -  Apr 6, 2014   
    P4,  N=97, Completed, 
    N=266 --> 97 Active, not recruiting --> Completed
  • ||||||||||  Grafix (cryopreserved placental membrane) / Osiris
    New P4 trial:  Grafix (clinicaltrials.gov) -  May 9, 2012   
    P4,  N=97, Completed,