• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » laViv (azficel-T)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

laViv (azficel-T)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    laViv (azficel-T) is an autologous cellular product. Collagen-producing fibroblast cells are harvested from the skin behind the ear. The fibroblasts from this tissue sample are cultured and allowed to multiply, so they can be injected to treat appropriate dermal targets. The exact mechanism of action is unknown.

    laViv is specifically indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults.

    laViv is for autologous intradermal injection only. The recommended treatment regimen is three treatment sessions, administering up to 2 milliliters (2 vials) of laViv per session, at three to six week intervals.

    Clinical Results

    FDA Approval
    The FDA approval of laViv was based on two identicall multi-center, randomized, double-blind, placebo controlled studies. The trial enrolled 421 subjects 23 to 81 years with moderate to severe bilateral nasolabial fold wrinkles. Each subject underwent three post-auricular skin punch biopsies to obtain skin tissue to generate laViv. Subjects whose biopsy samples met acceptance criteria were randomized to receive either laViv or placebo administered intradermally to nasolabial fold wrinkles on both sides of the face. A total of three separate treatment sessions occurred at intervals of approximately five weeks. For both clinical trials, the co-primary efficacy outcomes were the proportion of subjects with a two-point improvement from baseline in the appearance of the nasolabial fold wrinkles at six months after the third treatment session, assessed independently by subjects and by evaluating physicians. Subjects assessed their nasolabial fold wrinkles on a five-point Subject Wrinkle Assessment scale that ranged from -2 to +2. The evaluating physicians used a six-point Evaluator Wrinkle Severity Assessment scale that ranged from 0 to 5. When subjects assessed themselves, 57% (Study One) and 45% (Study Two) of subjects receiving laViv achieved a 2-point improvement in the appearance of their nasolabial fold wrinkles compared with 30% (Study One) and 18% (Study Two) of subjects receiving placebo control. When assessed by evaluating physicians, 33% (Study One) and 19% (Study Two) of subjects receiving laViv achieved a 2-point improvement in their nasolabial fold wrinkles, compared with 7% of subjects receiving vehicle-control in both trials.

    Side Effects

    Adverse events associated with the use of laViv may include, but are not limited to, the following:

    • injection-site redness
    • bruising
    • swelling
    • pain
    • hemorrhage
    • edema
    • nodules
    • papules
    • irritation
    • dermatitis
    • pruritus

    Mechanism of Action

    laViv (azficel-T) is an autologous cellular product. Collagen-producing fibroblast cells are harvested from the skin behind the ear. The fibroblasts from this tissue sample are cultured and allowed to multiply, so they can be injected to treat appropriate dermal targets. The exact mechanism of action is unknown.

    Additional Information

    For additional information regarding laViv or nasolabial fold wrinkles, please visit the laViv web page.

    Approval Date: 2011-06-01
    Company Name: Fibrocell Science
    Back to Listings

    Upcoming Events

    • 25Apr

      Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

    • 26Apr

      FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

    • 27Apr

      Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

    • 17May

      2023 WCG Avoca Quality Consortium Summit

    • 21May

      WCG MAGI Clinical Research Conference – 2023 East

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • tablet

      Digital Intake Platforms Effective as Source of Trial Information, Survey Shows

    • Diversity-360x240.png

      Site Spotlight: EmVenio Research Takes to the Road to Promote Trial Diversity

    • Five Ws

      Consider the Five ‘W’s to Understand Potential Participants

    • QandA-360x240.png

      Perspectives from Smaller-Sized CROs: Q&A with Cheryle Evans

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing