Neocutis Facts

The Facts

Following are excerpts from Neocutis, the NIH and science publications.

Neocutis Inc.
3053 Fillmore Street # 140
San Francisco CA 94123

Phone:
1-866-NEOCUTI
1-866-636-2884

http://neocutis.com/modules.php?modid=1

Neocutis S.A. was founded in February 2003 as a spin-off from the Medical School of the University Hospital of Lausanne, Switzerland.

PSP® in cosmetic research http://www.neocutis.com/categories.php?catid=11

Through years of research, physicians discovered fetal skin has a unique ability to heal wounds without scarring. Inspired by this, medical researchers at the University Hospital of Lausanne, Switzerland created a biotechnology process to extract the rich proteins responsible for scarless wound healing from cultured fetal skin cells. A small biopsy of fetal skin was donated following a one-time medical termination and a dedicated cell bank was established for developing new skin treatments. Originally established for wound healing and burn treatments, today this same cell bank also provides a lasting supply of cells for producing Neocutis’ proprietary skin care ingredient Processed Skin Cell Proteins (PSP®). No additional fetal biopsies will ever be required.

PSP® production and safety http://www.neocutis.com/article.php?sid=15

TECHNOLOGY / PSP® – a new skin nutrient

PSP® is obtained in a biotechnology derived process following stringent manufacturing procedures. A cell bank was established starting with a single skin biopsy of fetal skin tissue. The cell bank is stored frozen in liquid nitrogen and can be kept for many years, thereby providing a sustained supply of cells for PSP® production over decades.

The single skin tissue biopsy was obtained under informed consent in compliance with legal end ethical rules of the University Hospital of Lausanne in Switzerland. The skin sample was taken at the period of scarless wound healing. The biopsy was then transferred into a biotechnology facility for establishing a cell bank using standard cell culture techniques. The cell bank is composed of several hundred ampoules containing each several millions of cultured skin cells.

The cell bank testing included viral safety evaluation and characterization of cell substrates. It was performed in accordance with the requirements of Good Laboratory Practices for production of biotechnological/biological products. Besides the assessment of donor eligibility and serology testing at time of biopsy and after 3 months, this included a stringent testing for endogenous and adventitious agents in order to characterize the cell banks. Briefly, the cell banks were tested for human viruses, retroviruses, adventitious viral contaminants, sterility, mycoplasma as well as identity (Figure 1). The cell banks were shown to be free of viruses or viral adventitious agents, mycoplasma, bacteria or fungi.

Figure 1: Schematic overview of cell bank testing. PSP® (Processed Skin Cell Proteins) is obtained after cell lysis of cultured skin cells originating from this cell bank.

In order to produce PSP®, frozen cells from one or several ampoules of the Working Cell Bank are thawed, transferred into appropriate cell culture vessels and then expanded under standard cell culture condition respecting stringent manufacturing procedures. Thereby, cells from one Working Cell Bank ampoule are multiplied to yield several billion cells (Figure 2). These cells are then harvested, carefully washed and prepared for cell disruption. Cell disruption or lysis is realized by several freeze-thaw cycles and allows obtaining a mixture comprising skin cell proteins, called PSP® or ‘Processed Skin Cell Proteins’. Freeze-thawing is a relatively gentle process [22] and allows the production of a naturally balanced mixture of skin cell proteins present in the cells at the moment of cell disruption.

Figure 2: Schematic representation of PSP® production process by cell expansion in appropriate culture vessels (e.g. Cell Culture Flasks) starting with cells from one Working Cell Bank ampoule.

This process allows obtaining several billion cells, which are harvested and then freeze-thawed to finally obtain PSP®.

Dermatotoxicity studies showed that PSP® is well tolerated for external application in humans. A cumulative irritancy patch test during 21 days with 25 subjects and a repeated insult patch test with 200 subjects revealed that PSP® up to 0.5% is neither a contact irritant nor a contact allergen.

Articles on the same category:

PSP® production and safety

The present multi-center study aimed to investigate a novel eye cream which contained a proprietary mixture of human growth factors and cytokines (called PSP

or ‘processed skin cell proteins’) for periorbital rejuvenation. The mixture is obtained through a biotechnology process using cultured fetal skin cells from a

dedicated cell bank. A skin cream with the identical mixture of human growthfactors and cytokines as contained in the eye cream was recently shown to

significantly reduce signs of facial wrinkles and to improve skin texture.3 The eye cream further contained caffeine, bisabolol, glycyrrhetinic acid and sodium

hyaluronate. Eyelid skin is the thinnest in the body, of fragile nature and important function making the area particularly difficult to treat. 

“A dedicated cell bank was established for developing new skin treatments using a single donation of fetal tissue under the strict legal and ethical laws of Switzerland. Originally established for wound healing and burn treatments, this same cell bank provides a lasting supply of fibroblasts for producing PSP, a proprietary skincare ingredient exclusive to Neocutis.”

Development of Neocutis Bio-restorative Skin Cream  http://neocutis.com/article.php?sid=58

Neocutis Bio-restorative Skin Cream was developed at the University of Lausanne (Switzerland) based on an in-depth understanding of the nutritive needs of skin.

Neocutis Bio-restorative Skin Cream with PSP™ (a proprietary cosmetic ingredient developed at the University of Lausanne) is the only product containing the specific natural human growth factors and cytokines associated with natural bio-restoration of the skin. The unique formulation of PSP™ provides skin with the optimal balance of skin nutrients helping to preserve or restore skin when stressed.

 Composition of Bio-restorative Skin Cream  http://neocutis.com/article.php?sid=59

Bio-restorative Skin Cream is an oil-in-water emulsion designed for optimal efficacy of PSP™. The cream is free of fragrances, color additives and sunscreens, which ensures an excellent skin tolerability.

Besides PSP™, it is composed of the following ingredients: water (aqua), octyldodecanol, glyceryl stearate, decyl oleate, glycerin, propylene glycol, wheat germ oil (Triticum Vulgare), stearic acid, cetyl alcohol, ceteareth-20, myreth-3 myristate, ceteareth-12, cetearyl alcohol, cetyl palmitate, tocopheryl acetate, dimethicone, borage seed oil (Borago Officinalis), carbomer, triethanolamine, methylparaben, propylparaben, glycosphingolipids, phenoxyethanol, disodium EDTA, BHT, ethylparaben, butylparaben, methylisothiazolinone and methylchloroisothiazolinone.

http://www.ncbi.nlm.nih.gov/pubmed/17269452

De Buys Roessingh AS, Hohlfeld J, Scaletta C, Hirt-Burri N, Gerber S, Hohlfeld P, Gebbers JO, Applegate LA.

Department of Pediatric Surgery, University Hospital Lausanne, Lausanne, Switzerland.

Wound healing in fetal skin is characterized by the absence of scar tissue formation, which is not dependent on the intrauterine environment and amniotic fluid. Fetal cells have the capacity of extraordinary expansion and we describe herein the development of a fetal skin cell bank where from one organ donation (2-4 cm2) it is possible to produce several hundred million fetal skin constructs of 9 x 12 cm2. Fetal cells grow three to four times more rapidly than older skin cells cultured in the same manner and these banked fetal cells are very resistant against physical and oxidative stress when compared to adult skin cells under the same culture conditions. They are up to three times more resistant to UVA radiation and two times more resistant towards hydrogen peroxide treatment. This mechanism may be of major importance for fetal cells when they are delivered to hostile wound environments. For fetal cell delivery to patients, cells were associated with a collagen matrix to form a three-dimensional construct in order to analyze the capacity of these cells for treating various wounds. We have seen that fetal cells can modify the repair response of skin wounds by accelerating the repair process and reducing scarring in severe bums and wounds of various nature in children. Hundreds of thousands of patients could potentially be treated for acute and chronic wounds from one standardized and controlled cell bank.

PMID: 17269452 [PubMed – indexed for MEDLINE]

http://infoscience.epfl.ch/record/129015/files/ExpGer-Lee(2009).pdf   Excerpt: (pg 2)

“Cell lines established in the University Hospital of Lausanne from a fetal skin biopsy at 14 weeks of gestation (14 week male fetal

skin;14 wFS) obtained after pregnancy termination with informed and written consent and approval from the local Medical School Ethics Committee.