Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen

Identification

Summary

Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen is a viable, bioengineered, allogeneic, cellularized scaffold product applied to deep thermal burns to aid in healing.

Brand Names
StrataGraft
Generic Name
Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen
DrugBank Accession Number
DB16709
Background

Stratagraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat) is an allogeneic cellularized scaffold product used for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (also known as deep partial-thickness burns).2 It was developed as an alternative to autografting - the process by which a patient's own skin is harvested and grafted onto the burn site - which has the disadvantage of creating a new wound at the site from which the graft is taken.3

Stratagraft consists of two kinds of lab-grown skin cells, keratinocytes and dermal fibroblasts, which are grown together on a murine collagen matrix to make a bi-layered construct (i.e. a cellularized scaffold). Sheets containing this scaffold product are applied to the burn site and, as they contain metabolically active and viable cells, provide a variety of human growth factors and cytokines as well as extracellular matrix proteins, all of which are known to be involved in wound repair. The product does not remain permanently engrafted, instead being replaced by the patient's own cells over time, which can reduce or even eliminate the need for autografting.2

Stratagraft was in the early stages of development as far back as 20091 and was granted full FDA approval in June 2021.3

Type
Biotech
Groups
Approved
Biologic Classification
Cell transplant therapies
Other cell transplant therapies
Synonyms
  • allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat
  • Viable and metabolically active allogeneic human NIKS keratinocytes and human dermal fibroblasts cellularized layered scaffold

Pharmacology

Indication

Stratagraft is an allogeneic cellularized scaffold product indicated for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).2

Pharmacology
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Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
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Pharmacodynamics

Stratagraft is a topical rectangular sheet which is applied to excised and debrided thermal wound beds in order to aid in healing, serving a generally similar function to autologous skin grafting.2

Mechanism of action

Stratagraft consists of a murine collagen matrix with human keratinocytes and dermal fibroblasts embedded within. As these cells are viable and metabolically active, they secrete human growth factors and cytokines that help to heal the affected tissues. The Stratagraft cells are slowly replaced by the patient's own cells over time, which aids in wound closure and can help to eliminate or reduce the need for autologous skin grafting (i.e. autografting).2

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
Adverseeffects
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Toxicity

Following the administration of 14 cm2 (~25% BSA) to full-thickness wounds in immunocompromised athymic nude mice, no evidence of local or systemic toxicity was observed.2

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
ChlorhexidineThe therapeutic efficacy of Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen can be decreased when used in combination with Chlorhexidine.
MafenideThe therapeutic efficacy of Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen can be decreased when used in combination with Mafenide.
Silver sulfadiazineThe therapeutic efficacy of Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen can be decreased when used in combination with Silver sulfadiazine.
Interactions
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Food Interactions
No interactions found.

Products

Products2
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International/Other Brands
StrataGraft (Stratatech Corporation)
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
StrataGraftCellular Sheet1 cm2/1cm2TopicalStratatech Corporation2021-06-15Not applicableUS flag

Categories

Drug Categories
Classification
Not classified
Affected organisms
  • Humans and other mammals

Chemical Identifiers

UNII
Not Available
CAS number
Not Available

References

General References
  1. Schurr MJ, Foster KN, Centanni JM, Comer AR, Wicks A, Gibson AL, Thomas-Virnig CL, Schlosser SJ, Faucher LD, Lokuta MA, Allen-Hoffmann BL: Phase I/II clinical evaluation of StrataGraft: a consistent, pathogen-free human skin substitute. J Trauma. 2009 Mar;66(3):866-73; discussion 873-4. doi: 10.1097/TA.0b013e31819849d6. [Article]
  2. FDA Approved Drug Products: Stratagraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen- dsat) for topical use [Link]
  3. FDA Press Announcement: FDA Approves StrataGraft for the Treatment of Adults with Thermal Burns [Link]
Not Available

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
3CompletedTreatmentThermal Burns1
2RecruitingTreatmentFull Thickness Burns1
2TerminatedTreatmentBurns / Dermabrasion / Trauma-related Wound1
1CompletedTreatmentBurns / Dermabrasion / Trauma-related Wound1
1, 2CompletedTreatmentBurns / Degloving Injuries / Third Degree Burns / Wound Infections1
Not AvailableApproved for MarketingNot AvailableDeep Partial Thickness Burn1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Cellular sheetTopical1 cm2/1cm2
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Drug created at August 12, 2021 15:13 / Updated at August 13, 2021 04:45