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
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- Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.- 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
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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.
Drug Interaction Integrate drug-drug
interactions in your softwareChlorhexidine The therapeutic efficacy of Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen can be decreased when used in combination with Chlorhexidine. Mafenide The therapeutic efficacy of Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen can be decreased when used in combination with Mafenide. Silver sulfadiazine The therapeutic efficacy of Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen can be decreased when used in combination with Silver sulfadiazine. 
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- No interactions found.
Products
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- StrataGraft (Stratatech Corporation)
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image StrataGraft Cellular Sheet 1 cm2/1cm2 Topical Stratatech Corporation 2021-06-15 Not applicable US 
StrataGraft Cellular Sheet 1 cm2/1cm2 Topical Stratatech Corporation 2021-06-15 Not applicable US
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- Not Available
- CAS number
- Not Available
References
- General References
- 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]
- FDA Approved Drug Products: Stratagraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen- dsat) for topical use [Link]
- FDA Press Announcement: FDA Approves StrataGraft for the Treatment of Adults with Thermal Burns [Link]
- External Links
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 3 Completed Treatment Thermal Burns 1 3 Recruiting Treatment Burns / Dermabrasion / Trauma-related Wound 1 2 Recruiting Treatment Full Thickness Burns 1 2 Terminated Treatment Burns / Dermabrasion / Trauma-related Wound 1 1 Completed Treatment Burns / Dermabrasion / Trauma-related Wound 1 1, 2 Completed Treatment Burn With Full-Thickness Skin Loss / Burns / Degloving Injuries / Wound Infections 1 Not Available Approved for Marketing Not Available Deep Partial Thickness Burn 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Cellular sheet Topical 1 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