Delivery Scaffolds and Related Methods of Use

• US 20140037749A1
• Filed: 03/14/2013
• Published: 02/06/2014
• Est. Priority Date: 01/24/2008
• Status: Abandoned Application

• Current Assignee: Northwestern University
• Original Assignee: Northwestern University
• Inventors: Shea, Lonnie D., Rives, Christopher B., Lowe, William L.
• Application Number:
  US13/828,293
• Publication Number:
  US 20140037749A1
• Time in Patent Office: Days
• US Class Current: 424/501
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/7052 having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
• CPC Class Codes: A61K 35/39 Pancreas; Islets of Langerhans Langerhans cells of epidermis A61K35/36
• CPC Class Codes: A61K 38/2278 Vasoactive intestinal peptide [VIP]; Related peptides (e.g. Exendin)
• CPC Class Codes: A61K 38/39 Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/258 Genetic materials, DNA, RNA, genes, vectors, e.g. plasmids
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/622 Microcapsules
• CPC Class Codes: A61L 2300/64 Animal cells
• CPC Class Codes: A61L 27/00 Materials for grafts or prostheses or for coating grafts or prostheses dental prostheses A61C13/00; shape or structure of prostheses A61F2/00; use of preparations for artificial teeth A61K6/80; artificial kidneys A61M1/14
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/20 Polysaccharides
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/36 containing ingredients of undetermined constitution or reaction products thereof , e.g. transplant tissue, natural bone, extracellular matrix isolated natural compounds, e.g. collagen A61L27/24
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61P 3/10 : for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

The present invention relates to delivery systems. In particular, the present invention provides microporous scaffolds having thereon agents (e.g., extracellular matrix proteins, exendin-4) and biological material (e.g., pancreatic islet cells). In some embodiments, the scaffolds are used for transplanting biological material into a subject. In some embodiments, the scaffolds are used in the treatment of diseases (e.g., type 1 diabetes), and related methods (e.g., diagnostic methods, research methods, drug screening).

Claims

1. A scaffold composition for time-release delivery of biological or chemical agents to a subject, comprising:

a) a substantially non-porous inner layer having a biological or chemical agent associated therewith; and

b) porous outer layers having sufficient porosity to permit cellular ingrowth therein.

2. The composition of claim 1, wherein said substantially non-porous inner layer comprises said biological or chemical agent in encapsulated particles.

3. The composition of claim 2, wherein said encapsulated particles are microspheres.

4. The composition of claim 3, wherein said microspheres are poly(lactide-co-glycolide) microspheres.

5. The composition of claim 1, wherein said biological or chemical agent is a protein.

6. The composition of claim 1, wherein said biological or chemical agent is a cell.

7. The composition of claim 1, wherein said biological or chemical agents comprise exendin-4 and extracellular matrix proteins.

8. The composition of claim 7, further comprising pancreatic islet cells.

9. The composition of claim 1, wherein said inner layer is non-porous.

10. The composition of claim 1, wherein said inner layer is substantially free of salt.

11. The composition of claim 1, wherein said biological or chemical agent is nucleic acid.

12. The composition of claim 1, wherein said inner layer is composed of two or more different polymers.

13. The composition of claim 1, wherein said inner layer comprises two or more different biological or chemical agents.

14. The composition of claim 13, wherein each of said two or more different biological or chemical agents is contained in different microspheres, having different release rates.

15. The composition of claim 1, wherein said inner and outer layers are configured to permit slow-release of said biological or chemical agent over a period of at least 30 days.

16. The composition of claim 1, wherein said inner and outer layers are configured to permit slow-release of said biological or chemical agent over a period of at least 70 days.

17. A method of treating a subject, comprising:

administering the composition of claim 1 to a subject.

18. The method of claim 17, wherein subject has type 1 diabetes.

19. The method of claim 17, wherein the composition increases blood glucose control and/or restores euglycemia.