Gintuit cell therapy approval signals shift at US regulator

Schmidt, Charles
June 2012
Nature Biotechnology;Jun2012, Vol. 30 Issue 6, p479
Academic Journal
The article presents information on the approval of the U.S. Food and Drug Administration (FDA) for dubbed Gintuit, which is a form of regenerative cell therapy used in the case of gum recession. Dentists used to patch the receding gums using surgically sliced tissues which were a painful process called free gingival grafting. Gintuit has been developed by organogenesis based in Canton, Massachusetts. A focus is on the methods of preparing products like Apligraf and Gintuit.


Related Articles

  • An FDA perspective on preclinical development of cell-based regenerative medicine products. Bailey, Alexander M; Mendicino, Michael; Au, Patrick // Nature Biotechnology;Aug2014, Vol. 32 Issue 8, p721 

    The article focuses on U.S. Food and Drug Administration (FDA)'s report "Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products." The topics discussed include clinical testing of investigational regenerative medicine products, routes of administration...

  • Advancing science translates into value-creating milestones. Winter, Peter // BioWorld Insight;1/27/2014, Vol. 22 Issue 4, p2 

    The article discusses the clinical advancements achieved by the pharmaceutical companies and its impact on translating their business value. Take Athersys Inc. initiated a Phase II study in collaboration with Pfizer Inc. to evaluate the efficacy of Multistem cell therapy. Cardio3 Biosciences SA...

  • Biotechs in Aesthetics Space Mixing Science, Consumerism. Boggs, Jennifer // BioWorld Insight;4/25/2011, Vol. 19 Issue 17, p1 

    The article focuses on the growth of the facial aesthetics and body-shaping therapies that are approved by the U.S. Food & Drug Administration (FDA) in the biotechnology industry. It notes that FDA-approved cell therapy LaViv (azficel-T) is for facial aesthetics and is designed to treat...

  • Living Skin Substitute Can Heal Diabetic Foot Ulcer Wounds.  // FDA Consumer;Sep/Oct2000, Vol. 34 Issue 5, p6 

    Provides information about Apligraf, a wound dressing that contains human skin cells to help heal open wounds in the feet of diabetic individuals. Approval from the United States Food and Drug Administration; Composition of Apligraf; Study findings on the product.

  • Early Lineage Adult Regenerative Cells Offer Promising New Cell-based Therapy. Ritter, Amy // BioPharm International;Apr2011, Vol. 24 Issue 4, p10 

    The article offers information on the cell-based therapy provided by early lineage adult (ELLA) regenerative cells, developed by Parcell Laboratories of Massachusetts.

  • Start Reimbursement Planning Now for Regenerative Medicine. Orelli, Brian // BioWorld Insight;11/4/2013, Vol. 21 Issue 45, p2 

    The article focuses on a reimbursement guide developed by the Alliance for Regenerative Medicine which suggests the need for companies to plan their reimbursement from Medicare and private insurances ahead of the approval of U.S. Food and Drug Administration (FDA). It discusses the reimbursement...

  • Advanced Cell Technology Announces 2010 Results.  // Biomedical Market Newsletter;4/30/2011, p985 

    The article presents the 2010 year-end results for the period ended December 31, 2010 of Advanced Cell Technology Inc. (ACT), leader in the field of regenerative medicine. It notes that the company had used 8.8 million dollars in cash for operation in the year which is higher compared to 5.1...

  • Coalition aims to accelerate translation of cell therapies. Sinha, Gunjan // Nature Biotechnology;Jul2012, Vol. 30 Issue 7, p573 

    The article reports that spokespersons of six translational medicine centers working on cell based therapies met in Berlin, Germany to initiate the Regenerative Medicine Coalition (RMC). Frank-Roman Lauter, head of business development at Berlin-Brandenburg Center for RegenerativeTherapies in...

  • FDA Places Hold on Geron's Cell Therapy.  // Bioworld Week;5/19/2008, Vol. 16 Issue 20, p4 

    The article reports that the U.S. Food and Drug Administration has placed a hold on the investigational new drug application of Geron Corp. for GRNOPCI cell therapy. The company has not yet received a letter from the agency, explaining the reason for its move. In preclinical studies, the therapy...


Read the Article

Courtesy of

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics