Overview
Foreskin fibroblast-like stromal cells (FDSCs) are progenitors isolated from human tissue that can differentiate into various cell types . Also known as Dermagraft, this device is a cryopreserved human fibroblast-derived dermal substitute. Composed of fibroblasts, extracellular matrix, and a bioabsorbable scaffold, it effectively supports wound healing . Dermagraft has only been available in the United States as an investigational device (IDE). Dermagraft for the treatment of diabetic foot ulcers was approved for sale in Canada in 1997. Dermagraft was introduced in the United Kingdom in October 1997, and several other European countries, as well as New Zealand and Australia. The device is available for commercial distribution in Australia, Canada, Finland, France, Hong Kong, Ireland, The Netherlands, New Zealand, Singapore, and The United Kingdom . The impact of diabetic foot ulcers (DFU) on individuals and society is devastating. Failure to observe proper wound care in this condition often results in amputation. If wound closure is achieved, it is likely to delay the need for surgical intervention and provide other benefits such as improvements in productivity, mental outlook, social interactions, and time at work, in addition to decreased mortality . Interestingly, it has been shown that human foreskin cells possess immunosuppressive properties, which are mediated by other processes than that reported for bone marrow/stromal stem cells . Dermagraft has been combined with Foreskin keratinocyte (neonatal) to create a drug beneficial to patients with open burn wounds .
Indication
This device is indicated for use for the treatment of full-thickness, diabetic foot ulcers greater than six weeks duration which extends through the dermis, but without tendon, muscle, joint capsule or bone exposure. This drug should be used in conjunction with standard wound care regimens and in patients with an adequate blood supply to the involved foot .
Associated Conditions
- Wound of the Oral Cavity
Clinical Trials
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FDA Drug Approvals
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EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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Health Canada Drug Approvals
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CIMA AEMPS Drug Approvals
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Philippines FDA Drug Approvals
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Saudi SFDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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