Extracorporeal cell-based therapeutic device and delivery system

• US 8,048,419 B2
• Filed: 02/01/2007
• Issued: 11/01/2011
• Est. Priority Date: 02/02/2006
• Status: Active Grant

• Current Assignee: Seastar Medical, Inc. (LMF Acquisition Opportunities, Inc.)
• Original Assignee: Innovative Biotherapies, Inc.
• Inventors: Humes, H. David
• Primary Examiner(s): Ford; Vanessa L
• Assistant Examiner(s): TONGUE, LAKIA J
• Application Number:
  US11/670,123
• Publication Number:
  US 20070269489A1
• Time in Patent Office: 1,734 Days
• Field of Search: None
• US Class Current: 424/140.1
• CPC Class Codes: A61M 1/3489 by biological cells, e.g. bioreactor
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3687 Chemical treatment A61M1/3675 takes precedence
• CPC Class Codes: A61M 1/3689 by biological cells
• CPC Class Codes: A61M 2202/09 Body tissue
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Extracorporeal cell-based therapeutic devices and delivery systems are disclosed which provide a method for therapeutic delivery of biologically active molecules produced by living cells in response to a dynamic physiologic environment. Exemplary designs are disclosed. In a first exemplary embodiment the device includes long hollow fibers in which a layer of cells are grown within the intraluminal volume or within a double hollow-filled chamber. In another exemplary embodiment the device includes a wafer or a series of wafers forms a substrate onto which cells are grown. The wafer(s) are then inserted into a device. The devices are intended to be extracorporeal. Disclosed is a device for delivering a pre-selected molecule, for example, a hormone, into a mammal'"'"'s systemic circulation. The device may also deliver a member of different cell products. The device comprises an anchoring element that can be anchored to an inner wall of an extracorporeal tube for blood. The device also comprises a capsule that is held in place within the extracorporeal tube for blood or fluid by an anchor. The device is adapted to secure viable cells which produce and secrete the pre-selected molecule into blood or fluid passing the capsule. The invention also provides a minimally invasive method for percutaneously introducing into a preselected blood vessel or body cavity the device of the invention.

Claims

1. An extracorporeal cell based therapeutic device comprising:

(a) a housing defining an interior space and having viable renal cells disposed therein; and

(b) a frozen, niobium-coated carbon scaffold having a trabecular structure disposed within the housing, wherein the viable renal cells are attached to the scaffold.

2. The device of claim 1, wherein the scaffold comprises at least one disk and the cells are disposed on the at least one disk.

3. The device of claim 1, wherein the scaffold is porous.

4. The device of claim 1, wherein the scaffold comprises a bio-matrix coating selected from collagen IV, collagen I, laminin, and matrigel.

5. The device of claim 1, wherein the device further comprises an anchor system which is capable of attaching the device to an extracorporeal tube.

6. The device of claim 1, wherein the housing defines a plurality of pores.

7. The device of claim 1, wherein the device further comprises a porous barrier between the viable cells and a body fluid present when in use.

8. The device of claim 7, wherein the porous barrier produces ultrafiltrate.

9. The device of claim 1, wherein the device is adapted for use with peritoneal fluid.

10. A cryopreserved composition comprising renal cells attached to a frozen scaffold comprising a carbon material coated with niobium and comprising a trabecular structure.

11. The scaffold of claim 10, wherein the scaffold comprises a bio-matrix coating selected from collagen IV, collagen I, laminin, and matrigel.

12. The scaffold of claim 10, wherein the substrate is porous.