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http://www.wndu.com/content/news/Ne...e-patients-own-skin-in-the-lab-459149133.html
Treatment for severe burns usually includes skin grafts and months to years of therapy, all of which can be excruciatingly painful.
Now, a new product lets doctors regenerate a patient’s own fully-functional skin in the lab.
It has worked on pig skin so far, and SkinTE could be life-changing for burn patients.
“I just went to work one morning and turned the equipment on, and it flashed the whole first floor that I was in the middle of,” James Hillman recalls.
A propane explosion four years ago left James with second and third degree burns on over half his body.
“I remember laying there and seeing my tendon in my hands. It was burned so bad I had skin dripping off of it,” he says.
James spent three months in a burn unit. He had numerous skin grafts, where doctors move healthy skin over burns, and years of painful therapy.
Biotech company PolarityTE has developed a treatment to grow a patient’s own skin, potentially eliminating the need for skin grafts. A medical professional takes a two-centimeter graft from the patient and ships it off in the SkinTE box to a lab where the skin is grown in a 3D system in a matter of hours.
“It’s then returned to the patient and it literally grows on the patient, so the patient is used as its own medium,” explains Stephen Milner, MD.
It regenerates to full thickness, fully functional skin with new hair follicles in about three weeks.
“What’s so amazing to me is that you won’t need all those donor sites. So it does away with all that extra part of the body being scarred,” explains Linda Ware, OT, CHT.
James is studying to be a burn nurse, and someday he may help patients with SkinTE.
SkinTE is registered with the FDA, which means it is available in the U.S. There will be a limited release in 15 centers around the country and a wider release next year.
PolarityTE also hopes to begin a pilot human clinical trial later this year, although that’s not required by the FDA.
NEW TECHNOLOGY: While skin grafts and therapy are options for severe burn victims, the process can be long and painful for the patients. Now, a company called PolarityTE is using investigational platform technology to regenerate human skin to full-thickness and full function. The products name is SkinTE, and the process may eventually allow a patient’s own skin to be fully expanded from a small skin biopsy, regenerating all layers (the epidermis and dermis), hair and appendages. This has never been done before.
(Source: http://www.polarityte.com/products/skinte)
MORE FROM DR. MILNER: “A medical provider takes a 2cm full-thickness graft from the patient, and ships it off in the provided SkinTE box for processing, which takes a matter of hours, enabling the SkinTE product to be returned to the provider within approximately 48 hours. SkinTE is registered with the FDA as a human cell, tissue, and cellular and tissue-based product (HCT/P), which means it is available for appropriate human use in the United States. PolarityTE is currently in the process of initiating a pilot human clinical trial, although this is not required by the FDA because SkinTE is an HCT/P regulated solely under Section 361 of the Public Health Service Act, which does not require premarket approval or clearance from the FDA.”
(Source: Stephen Milner, MD, BDS, DSc, FRCSE, FACS)
Treatment for severe burns usually includes skin grafts and months to years of therapy, all of which can be excruciatingly painful.
Now, a new product lets doctors regenerate a patient’s own fully-functional skin in the lab.
It has worked on pig skin so far, and SkinTE could be life-changing for burn patients.
“I just went to work one morning and turned the equipment on, and it flashed the whole first floor that I was in the middle of,” James Hillman recalls.
A propane explosion four years ago left James with second and third degree burns on over half his body.
“I remember laying there and seeing my tendon in my hands. It was burned so bad I had skin dripping off of it,” he says.
James spent three months in a burn unit. He had numerous skin grafts, where doctors move healthy skin over burns, and years of painful therapy.
Biotech company PolarityTE has developed a treatment to grow a patient’s own skin, potentially eliminating the need for skin grafts. A medical professional takes a two-centimeter graft from the patient and ships it off in the SkinTE box to a lab where the skin is grown in a 3D system in a matter of hours.
“It’s then returned to the patient and it literally grows on the patient, so the patient is used as its own medium,” explains Stephen Milner, MD.
It regenerates to full thickness, fully functional skin with new hair follicles in about three weeks.
“What’s so amazing to me is that you won’t need all those donor sites. So it does away with all that extra part of the body being scarred,” explains Linda Ware, OT, CHT.
James is studying to be a burn nurse, and someday he may help patients with SkinTE.
SkinTE is registered with the FDA, which means it is available in the U.S. There will be a limited release in 15 centers around the country and a wider release next year.
PolarityTE also hopes to begin a pilot human clinical trial later this year, although that’s not required by the FDA.
NEW TECHNOLOGY: While skin grafts and therapy are options for severe burn victims, the process can be long and painful for the patients. Now, a company called PolarityTE is using investigational platform technology to regenerate human skin to full-thickness and full function. The products name is SkinTE, and the process may eventually allow a patient’s own skin to be fully expanded from a small skin biopsy, regenerating all layers (the epidermis and dermis), hair and appendages. This has never been done before.
(Source: http://www.polarityte.com/products/skinte)
MORE FROM DR. MILNER: “A medical provider takes a 2cm full-thickness graft from the patient, and ships it off in the provided SkinTE box for processing, which takes a matter of hours, enabling the SkinTE product to be returned to the provider within approximately 48 hours. SkinTE is registered with the FDA as a human cell, tissue, and cellular and tissue-based product (HCT/P), which means it is available for appropriate human use in the United States. PolarityTE is currently in the process of initiating a pilot human clinical trial, although this is not required by the FDA because SkinTE is an HCT/P regulated solely under Section 361 of the Public Health Service Act, which does not require premarket approval or clearance from the FDA.”
(Source: Stephen Milner, MD, BDS, DSc, FRCSE, FACS)
