CDEK
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azficel-T

Trade name: Laviv

Cell therapyapproved

Approved

Jun 21, 2011

Azficel-T, sold under the brand name Laviv, is a cell therapy product used to treat moderate to severe nasolabial fold wrinkles in adults. — Wikipedia

Clinical trial activity

12 trials · 12 clinical orgs · 1 marketing orgs

Phase 1
2
Phase 2
7
Phase 3
3
Phase 4
2

Earliest trial started Jan 1, 2006 (NCT00655889)

Timeline

2000s

  1. Jan 1, 2006

    Fibrocell Technologies, Inc. — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2006

    Fibrocell Technologies, Inc. — Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. Jun 21, 2011

    Fibrocell Technologies, Inc. — Earliest FDA Approval

  3. Jun 21, 2011

    Fibrocell Technologies, Inc. — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Unknown

    Dermal fibroblasts cultured from a patient sample for aesthetic surgery

  • FibroblastsSupplementation

    Fibroblasts supplementation

Approval history

  • approvedJun 21, 2011

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • autologous cultured fibroblasts
  • autologous fibroblast
  • autologous fibroblasts
  • azficel-t
  • azficel-t
  • azficel-t
  • azficel-t
  • it
  • it
  • laiv
  • laviv

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT02250274Phase 4Sep 1, 2014Centers for Disease Control and Prevention (CDC), Marshfield Clinic Research Foundation, University of Wisconsin
NCT02120781Phase 2Mar 1, 2014Fibrocell Technologies, Inc., University of California, Los Angeles
NCT01858753Phase 2May 1, 2013Fibrocell Technologies, Inc., University of South Florida
NCT02597647Phase 1Feb 1, 2011J. Craig Venter Institute, University of California, Los Angeles
NCT01246999Phase 4Oct 1, 2010Dartmouth University, National Institutes of Health (NIH), University of Rochester
NCT01908088Phase 1Jul 1, 2010Hazrat Fatemeh Hospital, Royan Institute
NCT00620737Phase 2Feb 1, 2008Fibrocell Technologies, Inc.
NCT00642642Phase 2/Phase 3 (Phase 3)Nov 1, 2007Fibrocell Technologies, Inc.
NCT00654654Phase 2Mar 1, 2007Fibrocell Technologies, Inc.
NCT00655356Phase 3Nov 1, 2006Fibrocell Technologies, Inc.
NCT00649428Phase 3Oct 1, 2006Fibrocell Technologies, Inc.
NCT00655889Phase 2Jan 1, 2006Fibrocell Technologies, Inc.
Showing 12 of 12 trials
Page 1 / 1

Organizations

Research & Development (12)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Fibrocell Technologies, Inc.For profit8822006
University of California, Los AngelesAcademic/Hospital2122011
Centers for Disease Control and Prevention (CDC)Government1012014
Dartmouth UniversityAcademic/Hospital1012010
Hazrat Fatemeh HospitalAcademic/Hospital1012010
J. Craig Venter InstituteAcademic/Hospital1012011
Marshfield Clinic Research FoundationAcademic/Hospital1112014
National Institutes of Health (NIH)Government1012010
Royan InstituteAcademic/Hospital1112010
University of RochesterAcademic/Hospital1112010
University of South FloridaAcademic/Hospital1012013
University of WisconsinAcademic/Hospital1012014
12 organizations
Page 1 / 1

Marketing (1)

OrganizationOrg typeRelationshipDate
Fibrocell Technologies, Inc.For profitNDAJun 21, 2011