Azficel-T

Identification

Name
Azficel-T
Accession Number
DB11051
Description

Azficel-T is an autologous cellular product composed of fibroblasts indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. Dermal fibroblasts are collected from the post-auricular biopsy tissue and aseptically expanded using standard tissue-culture procedures until sufficient cells for three doses are obtained Label. Expanded cells are then suspended in a cell medium. As a replacement for lost dermal constituents in the aging or skin deformation process, treatment with autologous fibroblasts has shown to improve wrinkle and acne scar appearance than with placebo treatment 2,4. Intradermal administration of autologous dermal fibroblasts into irradiated skin following surgical procedures was associated with an improved healing process of subsequent surgical wounds 5. Azficel-T is marketed in the US as Laviv for intradermal injection.

Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Cell transplant therapies
Autologous cell transplant
Synonyms
  • Autologous cultured fibroblasts
  • Azficel-T

Pharmacology

Pharmacology
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Indication

Indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults Label.

Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
Contraindications & Blackbox Warnings
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Pharmacodynamics

In clinical studies involving patients with moderate to severe bilateral nasolabial fold wrinkles, there was a substantial improvement in the wrinkle appearance Label. In a randomized multicenter, double-blind, placebo-controlled trial in subjects with bilateral moderate to severe acne scarring, treatment of autologous fibroblast treatment was associated with a significant improvement in the appearance of acne scars without permanent adverse reactions 2.

Mechanism of action

The mechanism of action of azficel-T, or autologous human fibroblasts, is not fully elucidated. Autologous fibroblasts correct dermal defects such as acne or other dermal conditions associated with aging, such as reduced elasticity. The importance of collagen matrix production by fibroblasts in maintaining skin integrity and reducing the appearance of scars has been highlighted. The appearance of acne scars is also associated with the loss of collagen at the site of inflammation following resolution of localized intense inflammation and wound healing associated with inflammatory acne 2. Fragmentation of the dermal collagen matrix occurs in the natural aging process; due to UV-induced photodamage and the actions of collagen-degrading enzymes (matrix metalloproteinases, MMPs) overtime, the structural integrity of the dermis and function of fibroblasts may be impaired 3. While fibroblasts are responsible in the synthesis, organization, regulation and the maintenance of collagen network, the function of fibroblasts are strongly dependent on the physical properties of collagen fibres, and vice versa 3. The aging process is associated with a reduced rate of collagen turnover and formation of modified crosslinks that normally give structural support for collagen fibres. These crosslinks prevent the removal of degraded collagen, leading to accumulation of collagen fragments within the extracellular matrix, and compromised structural and mechanical integrity of the dermis 3. Integrins that are expressed by the fibroblasts allow the cell to bind to collagen matrix and allow mechanical tension within fibroblasts and the collagenous matrix. In the presence of fragmented collagen, the fibroblasts lose attachment to the collagen matrix and collapse within the dermis and subsequently leads to reduced collagen production and increased production of MMPs 3. Autologous human fibroblasts have the ability to increase the formation of human collagen in vivo and promote remodelling of pre-existing extracellular matrix in the scarred tissue 2,6. They may also decrease the degradation of collagen 6.

Absorption
Not Available
Volume of distribution
Not Available
Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half-life
Not Available
Clearance
Not Available
Adverse Effects
Medicalerrors
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Toxicity

The adverse reactions from azficel-T treatment tend to be limited to injection site reactions Label.

Affected organisms
  • Humans and other mammals
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
AbciximabThe risk or severity of adverse effects can be increased when Abciximab is combined with Azficel-T.
AceclofenacThe risk or severity of adverse effects can be increased when Aceclofenac is combined with Azficel-T.
AcemetacinThe risk or severity of adverse effects can be increased when Acemetacin is combined with Azficel-T.
AcenocoumarolThe risk or severity of adverse effects can be increased when Acenocoumarol is combined with Azficel-T.
Acetylsalicylic acidThe risk or severity of adverse effects can be increased when Acetylsalicylic acid is combined with Azficel-T.
AlclofenacThe risk or severity of adverse effects can be increased when Alclofenac is combined with Azficel-T.
AlteplaseThe risk or severity of adverse effects can be increased when Alteplase is combined with Azficel-T.
AminophenazoneThe risk or severity of adverse effects can be increased when Aminophenazone is combined with Azficel-T.
AncrodThe risk or severity of adverse effects can be increased when Ancrod is combined with Azficel-T.
AnistreplaseThe risk or severity of adverse effects can be increased when Anistreplase is combined with Azficel-T.
Interactions
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Food Interactions
Not Available

Products

Products
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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
LavivInjection, suspension15000000 1/1mLIntradermalFibrocell Technologies, Inc.2011-07-152016-09-30US flag

Categories

Drug Categories
Classification
Not classified

Chemical Identifiers

UNII
022461SR75
CAS number
Not Available

References

General References
  1. Smith SR, Munavalli G, Weiss R, Maslowski JM, Hennegan KP, Novak JM: A multicenter, double-blind, placebo-controlled trial of autologous fibroblast therapy for the treatment of nasolabial fold wrinkles. Dermatol Surg. 2012 Jul;38(7 Pt 2):1234-43. doi: 10.1111/j.1524-4725.2012.02349.x. Epub 2012 Mar 12. [PubMed:22409385]
  2. Munavalli GS, Smith S, Maslowski JM, Weiss RA: Successful treatment of depressed, distensible acne scars using autologous fibroblasts: a multi-site, prospective, double blind, placebo-controlled clinical trial. Dermatol Surg. 2013 Aug;39(8):1226-36. doi: 10.1111/dsu.12204. Epub 2013 Apr 8. [PubMed:23566237]
  3. Fisher GJ, Varani J, Voorhees JJ: Looking older: fibroblast collapse and therapeutic implications. Arch Dermatol. 2008 May;144(5):666-72. doi: 10.1001/archderm.144.5.666. [PubMed:18490597]
  4. Eca LP, Pinto DG, de Pinho AM, Mazzetti MP, Odo ME: Autologous fibroblast culture in the repair of aging skin. Dermatol Surg. 2012 Feb;38(2):180-4. doi: 10.1111/j.1524-4725.2011.02192.x. Epub 2011 Oct 10. [PubMed:22092878]
  5. Ferguson PC, Boynton EL, Wunder JS, Hill RP, O'Sullivan B, Sandhu JS, Bell RS: Intradermal injection of autologous dermal fibroblasts improves wound healing in irradiated skin. J Surg Res. 1999 Aug;85(2):331-8. doi: 10.1006/jsre.1999.5664. [PubMed:10423337]
  6. Nilforoushzadeh MA, Siadat AH, Arianrad M, Moulavi F, Baradaran EH, Esfahani MH: Soft tissue augmentation by autologous cultured fibroblasts transplantation for treatment of wrinkles and scars: a case series of 20 patients. J Res Med Sci. 2010 May;15(3):167-71. [PubMed:21526076]
  7. FDA Approved Drug Products: LAVIV (azficel-T) Suspension for Intradermal Injection [Link]
PubChem Substance
347911094
RxNav
1114112
FDA label
Download (192 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
3CompletedTreatmentBilateral Nasolabial Fold Wrinkles2
2CompletedTreatmentAge-related Dysphonia / Dysphonia Resulting From Vocal Fold Scarring1
2CompletedTreatmentFacial Wrinkles and Creases1
2CompletedTreatmentInterdental Papillary Insufficiency1
2TerminatedTreatmentRestrictive Burn Scars1
2, 3CompletedTreatmentAcne Scarring of the Face1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, suspensionIntradermal15000000 1/1mL
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Drug created on December 01, 2015 20:05 / Updated on February 21, 2021 18:52