Methods of manufacture of immunocompatible amniotic membrane products

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...

AI Technical Summary

Benefits of technology

[0038]The present inventors have identified a need for the development of amniotic membrane products comprising at least one of IGFBP1, and adiponectin, providing superior wound healing properties.

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 dressing relative to products that require less than three washing steps.

Engineered wound dressings 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).

Images