Methods of manufacture of immunocompatible amniotic membrane products

a technology of amniotic membrane and amniotic fluid, which is applied in the direction of embryonic cells, drug compositions, peptide/protein ingredients, etc., can solve the problems of insufficient cell viability to bestow biological effect, increase the risk of disease transmission, and inability to provide sufficient cell viability to achieve the effect of superior wound healing

Inactive Publication Date: 2011-08-25
OSIRIS THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0038]The present inventors have identified a need for the development of amniotic membrane produc

Problems solved by technology

When fresh AM is used, there is increased risk of disease transmission.
According to published reports, glycerol storage of AM resulted in immediate cell death.
Glycerol cryopreserved AM (−80° C.) and glycerol-preserved AM (−4° C.) are sufficient to provide a matrix for wound healing, but fail to provide sufficient cell viability to bestow biological effectivene
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 wound d

Method used

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  • Methods of manufacture of immunocompatible amniotic membrane products
  • Methods of manufacture of immunocompatible amniotic membrane products
  • Methods of manufacture of immunocompatible amniotic membrane products

Examples

Experimental program
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Effect test

example 1

Characterization of Placental Membranes

[0315]Cells in placental membranes were characterized 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.

[0316]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.

[0317]Evaluation of proteins secreted by examplary placental products of the invention in comparison to Apligraf and Dermagraft demonstrated a number of growth factors presen...

example 2

Exemplary Manufacturing Process of a Placental Product

[0318]In one embodiment, the present invention is a method of manufacturing a placental product comprising an amniotic membrane and optionally a chorionic membrane from placenta post partum. One such method is:[0319]a. Remove umbilical cord close to placental surface,[0320]b. Blunt dissect of the amnion to placental skirt,[0321]c. Flip placenta over and completely remove amnion,[0322]d. Rinse amnion in PBS to remove red blood cells,[0323]e. Rinse amnion once with 11% ACD-A solution to assist in red blood cell removal,[0324]f. Rinse amnion with PBS to remove ACD-A solution,[0325]g. Use PBS to remove any remaining blood from the amnion,[0326]h. Gently remove the connective tissue layer from the amnion,[0327]i. Place the amnion in PBS and set aside,[0328]j. Place the amnion into a bottle containing antibiotic solution and incubate at 37° C.±2° C. for 24-28 hrs,[0329]k. Remove bottle from the incubator and rinse membrane with PBS to ...

example 3

Exemplary Manufacturing Process of a Placental Product Containing an Amniotic Membrane and a Chorionic Membrane

[0337]In one embodiment, the present invention is a method of manufacturing a placental product comprising an amniotic membrane and optionally a chorionic membranes from placenta post partum. One such method is:[0338]a. Remove umbilical cord close to placental surface,[0339]b. Blunt dissect of the amnion to placental skirt,[0340]c. Flip placenta over and completely remove amnion,[0341]d. Remove chorion by cutting around placental skirt,[0342]e. Rinse both membranes in PBS to remove red blood cells,[0343]f. Rinse both membranes once with 11% ACD-A solution to assist in red blood cell removal,[0344]g. Rinse both membranes with PBS to remove ACD-A solution, \[0345]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,[0346]i. Gently remove the connective t...

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Abstract

Provided herein is a placental product comprising an immunocompatible amniotic 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 Applications Ser. No. 61 / 338,464 entitled “Selectively Immunodepleted Chorionic Membranes”, filed on Feb. 18, 2010 bearing Docket No. 22924US01,[0003]U.S. Provisional Applications Ser. No, 61 / 338,489 entitled “Selectively Immunodepleted Amniotic Membranes”, filed on Feb. 18, 2010 bearing Docket No. 22925US01, and[0004]U.S. Provisional Applications 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 Chorionic Membrane Products”,[0008]“Immunocompatible Amniotic Membrane Products”,[0009]“Therapeutic Products Comprisi...

Claims

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Application Information

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IPC IPC(8): A61K35/50A61P17/02A01N1/02
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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