Immunocompatible chorionic membrane products

a chorionic membrane and immunocompatibility technology, applied in the field of products, can solve the problems of increased risk of disease transmission, non-commercial wound healing products, less wound healing capacity of products with non-native cellular populations, etc., and achieve the effect of superior wound healing properties

Inactive Publication Date: 2011-09-01
OSIRIS THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0034]The present inventors have identified a need for the development of chorionic membrane products comprising at least one of IGFBP1, and adiponectin, providing superior wound healing properties.

Problems solved by technology

When fresh CM is used, there is increased risk of disease transmission.
As the CM is believed to be immunogenic, it has not been used in commercial wound healing products.
As wound healing is a multi-factorial biological process, many factors are needed to properly treat a wound; products having non-native cellular populations are less capable of healing wounds relative to a product having an optimal population of cells representing the native array.
According to its product literature, Dermagraft requires three washing steps before use which limits the practical implementation of Dermagraft as a skin substitute relative to products that require less than three washing steps.
Engineered skin substitutes such as Apligraf and Dermagraft do not provide the best potential for wound healing because they comprise sub-optimal cellular compositions and therefore do not provide proper wound healing.
For example, neither Apligraf nor Dermagraft comprises stem cells and, as a result, the ratio between different factors secreted by cells does not enable efficient wound healing.
In chronic wounds like diabetic ulcers or venous ulcers, the presence of high amount of proteases leads to rapid degradation of growth factors and delays in wound healing.
The process of wound healing is highly complex and involves a series of structured events controlled by growth factors (Goldman, Adv Skin Wound Care, 2004, 1:24).

Method used

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  • Immunocompatible chorionic membrane products
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Examples

Experimental program
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Effect test

example 1

Characterization of Placental Membranes

[0321]Characterization of cells in placental membranes by Fluorescence Activated Cell Sorting (FACS) demonstrated the presence of stromal cells (Mesenchymal Stem Cell-like cells) in addition to fetal epithelial cells and fibroblasts in amniotic and / or chorionic membranes.

[0322]One unique characteristic of the presently disclosed placental products is the presence of MSCs, which have been shown to be one of three types of cells (in addition to epithelial cells and fibroblasts) that are important for wound healing. Placental membranes secrete a variety of factors involved in wound healing such as angiogenic factors, factors supporting proliferation and migration of epithelial cells and fibroblasts, factors attracting endothelial stem cells from blood circulation to the wound site, antibacterial factors, and others.

[0323]Evaluation of proteins secreted by exemplary placental products of the invention in comparison to Apligraf and Dermagraft demons...

example 2

Exemplary Manufacturing Process of a Placental Product

[0324]In one embodiment, the present application discloses a procedure for manufacturing chorionic membranes from placenta post partum.

example 2.1

Exemplary Manufacturing Process of Chorionic Membrane Product

[0325]One method of manufacturing a placental product comprising a chorionic membrane according to the presently disclosed manufacturing procedure is as follows:[0326]a. Remove umbilical cord close to placental surface,[0327]b. Blunt dissect of the amnion to placental skirt,[0328]c. Flip placenta over and completely remove amnion,[0329]d. Remove chorion by cutting around placental skirt,[0330]e. Rinse the chorionic membrane in PBS to remove red blood cells,[0331]f. Rinse the chorionic membrane once with 11% ACD-A solution to assist in red blood cell removal,[0332]g. Rinse the chorionic membrane PBS to remove ACD-A solution,[0333]h. Treat chorion in 0.5% dispase solution at 37° C.±2° C. for 30-45 minutes, optionally, during dispase incubation period, use PBS to remove any remaining blood from the amnion,[0334]i. When dispase treatment is complete, rinse chorion with PBS to remove dispase solution,[0335]j. Gently remove trop...

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Abstract

Provided herein is a placental product comprising an immunocompatible chorionic membrane. Such placental products can be cryopreserved and contain viable therapeutic cells after thawing. The placental product of the present invention is useful in treating a patient with a tissue injury (e.g. wound or burn) by applying the placental product to the injury. Similar application is useful with ligament and tendon repair and for engraftment procedures such as bone engraftment.

Description

RELATED APPLICATIONS[0001]This application claims priority to:[0002]U.S. Provisional Application Ser. No. 61 / 338,464 entitled “Selectively Immunodepleted Chorionic Membranes”, filed on Feb. 18, 2010 bearing Docket No. 22924US01,[0003]U.S. Provisional Application Ser. No. 61 / 338,489 entitled “Selectively Immunodepleted Amniotic Membranes”, filed on Feb. 18, 2010 bearing Docket No. 22925US01, and[0004]U.S. Provisional Application Ser. No. 61 / 369,562 entitled “Therapeutic Products Comprising Vitalized Placental Dispersions filed on Jul. 30, 2010 bearing Docket No 23498US01, the contents of which are hereby incorporated by reference in their entireties.[0005]This application is being co-filed on Feb. 18, 2011 with, and incorporates by reference, applications entitled:[0006]“Methods of Manufacture of Immunocompatible Chorionic Membrane Products”,[0007]“Immunocompatible Amniotic Membrane Products”,[0008]“Methods of Manufacture of Immunocompatible Amniotic Membrane Products”,[0009]“Therape...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/70A61K35/50A61K9/00A61P43/00A61P17/02
CPCA01N1/0221A61K35/50A61K38/1825A61K38/1841C12N2501/115A61K38/57A61K35/28C12N5/0605A61K38/39C12N2500/02C12N2502/025A61P17/00A61P17/02A61P43/00
Inventor TOM, SAMSONDANILKOVITCH, ALLAYOO, DANAJANSEN, TIMOTHYKUANG, JIN-QIANGMARCONI, JENNIFER MICHELLE
Owner OSIRIS THERAPEUTICS
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