Neonatal
Neonatal Uses, Dosage, Side Effects, Food Interaction and all others data.
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 .
| Trade Name | Neonatal |
| Generic | Foreskin fibroblast (neonatal) |
| Foreskin fibroblast (neonatal) Other Names | foreskin fibroblast, neonatal |
| Type | |
| Groups | Approved |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Neonatal is a treatment of cells used to treat full-thickness, diabetic foot ulcers that extend through the dermis without tendon, muscle, joint capsule, or bone exposure.
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 .
Neonatal is also used to associated treatment for these conditions: Wound of the Oral Cavity
How Neonatal works
Dermagraft is a cryopreserved, human fibroblast-derived dermal substitute that contains fibroblasts, extracellular matrix, and a bioabsorbable polyglactin mesh scaffold . The fibroblasts are obtained from human newborn foreskin tissue. The fibroblasts are then placed on a scaffold and progress to proliferate and produce human dermal collagen, matrix proteins, growth factors, and cytokines. The above steps create a three-dimensional human dermal substitute with active human cells. Dermagraft does not contain macrophages, lymphocytes, blood vessels, nor hair follicles. It is available frozen as a single sheet (2 by 3 inches) for a single application .
Toxicity
No serious adverse events were attributed to Dermagraft. Of the 314 patients enrolled in a preclinical study, 10.4% (17/163) of the patients developed an infection while 17.9% (27/151) of the control group patients developed an ulcer infection. Overall, 31/163 (19%) of the dermagraft group developed infection, cellulitis, or osteomyelitis. In the control group, 49/151 (32.5%) patients developed the same adverse events. Thus, there was a lower rate of infection, cellulitis, and osteomyelitis in the dermagraft treated group .
Food Interaction
No interactions found.Innovators Monograph
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