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Fetal skin cell protein compositions for the treatment of skin conditions, disorders or diseases and methods of making and using the same

a skin condition, skin cell technology, applied in the direction of peptide/protein ingredients, immunological disorders, peptide sources, etc., can solve the problems of increased collagen deposition and scarring, less optimal or less balanced cellular response in non-fetal skin, and fetal wounds producing

Inactive Publication Date: 2006-03-16
NEOCUTIS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0015] The present invention provides a composition for treating a subject suffering from a skin condition, disorder or disease which includes one or mor

Problems solved by technology

Newborn, young and adult skin (corresponding to non fetal skin), however, heal with scar formation after wounding, which indicates that the coordinated cellular response in non-fetal skin is less optimal or less balanced than in fetal skin.
In addition, introduction of inflammation into normally scarless-healing wounds results in increases in collagen deposition and scarring.
In addition, it appears that the relative proportion of TGF-beta isoforms and not the absolute amount of any one isoform determines the wound repair outcome.
In turn, the addition of IL-6 to fetal wounds produces early scarring.
Current therapies do not provide a mechanism for scarless healing.

Method used

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  • Fetal skin cell protein compositions for the treatment of skin conditions, disorders or diseases and methods of making and using the same
  • Fetal skin cell protein compositions for the treatment of skin conditions, disorders or diseases and methods of making and using the same
  • Fetal skin cell protein compositions for the treatment of skin conditions, disorders or diseases and methods of making and using the same

Examples

Experimental program
Comparison scheme
Effect test

example 1

Fetal Skin Tissue Sampling

[0267] A fetal skin tissue sample (skin biopsy) was obtained from fetal skin immediately following pregnancy interruption in accordance with the policies and procedures of the Ethics Committee of the University Hospital Lausanne, Switzerland.

[0268] Donor eligibility and donor (mother) serology was assessed according to current FDA (http: / / www.fda.gov / cber / index.html) and ICH (http: / / www.ich.org) regulations, guidelines and recommendations. The donor's medical history and serology was compatible with those guidelines and recommendations at the period of tissue donation.

[0269] Donor eligibility included the assessment of clinical evidence for HIV, Hepatitis B, Hepatitis C, human TSE including CJD, Treponema pallidum, and risks associated with xenotransplantation (not receiving corneal and / or dura mater grafts and not receiving human growth hormones obtained from cadavers) by interview. Serology testing included assessment for presence of HIV I, HIV II, Cyt...

example 2

Fetal Skin Cell Bank

[0273] A typical procedure for establishing a fetal skin cell bank comprising a Master (MCB) and a Working Cell Bank (WCB) starting with fetal skin tissue and / or a fetal skin biopsy sample is hereby given. Generally, a cell bank is created with fetal skin from one donor. The fetal skin sample to create the cell bank was obtained as described in Example 1 after pregnancy interruption. The fetal skin sample (biopsy) was obtained at 16 weeks gestation and was of approximately 4 cm2.

[0274] From the skin sample, tissue fragments of about 0.5 mm3 and smaller were prepared by scissors and / or the use of scalpels or other cutting devices. The fragments were then seeded into sterile plates (e.g.: 10 cm diameter) at approximately 10 fragments per plate. These fragments were grown in Dulbecco's Modification of Eagle's Medium (DMEM) supplemented with 10% fetal bovine serum (FCS, Hyclone) in a 37° C., 10% CO2 and 95% humidity incubator. Medium exchange occurred every second ...

example 3

Fetal Skin Cell Expansion

[0282] In order to produce fetal skin cell proteins, fetal skin cells from the fetal skin cell bank are used, seeded in appropriate culture containers, grown (expanded, multiplied) under appropriate culture conditions, harvested after an appropriate number of passages and subsequently lysed by mechanical, physical or chemical means. A typical procedure of the cell expansion process starting with one or more vials from the WCB (obtained as described in Example 2) is hereby given. A typical procedure of the fetal skin cell harvest and the subsequent cell lysis is given in Example 4.

[0283] On initiation day, one vial of the WCB (contained about 2 to 3 Mio cells; cells are at passage 3) was rapidly thawed in a 37°±2°0 C. water-bath until ice has just melted. The contents of the vial was added to about 9 ml of pre-warmed DMEM, 10% FCS and then centrifuged at approximately 200 g (about 936 rpm) for about 10 min in a Beckman GH3.8 swing out rotor (or equivalent)....

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Abstract

The present invention provides methods and compositions designed for treating a subject suffering from skin conditions, disorders or diseases. The compositions include fetal skin cell proteins obtained from fetal skin cells after induced cell lysis.

Description

RELATED APPLICATIONS [0001] This application claims priority to, and the benefit of, U.S. Provisional Patent Application No. 60 / 610,613, filed Sep. 15, 2004 and U.S. Provisional Patent Application No. 60 / 641,067, filed Jan. 3, 2005. The contents of these applications are incorporated by reference in their entireties.FIELD OF THE INVENTION [0002] The present invention relates to methods and compositions designed for treating a subject suffering from skin conditions, disorders or diseases. The compositions contain fetal skin cell proteins obtained from fetal skin cells after induced cell lysis. BACKGROUND OF THE INVENTION [0003] Up to a certain age of gestation, fetal skin heals with no or only very minor scar formation (also called scarless repair or scarless healing) after wounding (Dang C et al., Clin Plast Surg 2003: 30, 13-23), which indicates an optimal (balanced) orchestration (regulation) of a coordinated cellular response in fetal skin during a specific time period of gestati...

Claims

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Application Information

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IPC IPC(8): A61K38/17
CPCA61K38/014A61K8/64A61Q17/04A61K45/06A61K38/1709A61Q19/00A61Q19/08A61K8/985A61P15/00A61P17/00A61P17/02A61P29/00A61P37/08A61K38/17
Inventor LAURENT-APPLEGATE, LEEHOHLFELD, PATRICK
Owner NEOCUTIS
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