Method and apparatus for therapeutically treating immunological disorders and disease states

• US 5,026,365 A
• Filed: 04/29/1987
• Issued: 06/25/1991
• Est. Priority Date: 04/29/1987
• Status: Expired due to Fees

• Current Assignee: University Of Massachusetts
• Original Assignee: University Of Massachusetts
• Inventors: Mordes, John P., Handler, Eugene S., Rossini, Aldo A.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Rose, Sharon
• Application Number:
  US07/043,934
• Time in Patent Office: 1,518 Days
• Field of Search: 604/891.1, 604/890.1, 604/27, 604/28, 604/93, 623/11, 424/422-424, 424/83, 514/866, 514/885
• US Class Current: 604/891.1
• CPC Class Codes: A61F 2/022 Artificial gland structures using bioreactors hemodialysis A61M1/16; hemofiltration A61M1/34; other extracorporeal blood treatment A61M1/36
• CPC Class Codes: A61K 35/17 Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes when activated by a specific antigen A61K39/00
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61M 1/3472 with treatment of the filtrate
• CPC Class Codes: A61M 1/3687 Chemical treatment A61M1/3675 takes precedence
• CPC Class Codes: A61M 1/3689 by biological cells

Abstract

A unique method and apparatus for therapeutically treating immunological disorders and disease states which are characterized by the present of immunologically abnormal leukocytes in the body of the afflicted subject is provided. The apparatus and methodology utilized a sealed diffusion chamber which may be surgically implanted in-vivo or may be extracorporeally joined to the circulatory system of the afflicted subject. In either mode of use, the diffusion chamber utilizes immunologically normal leukocytes of various types and concentration which are able to provide cell functions and cellular secretory products which therapeutically counterbalance the effects of the immunological abnormality within the afflicted subject.

Claims

1. An in-situ immunological method for therapeutically treating disorders and disease states which are characterized by the presence of immunologically abnormal leukocytes in the body of an afflicted subject, said method comprising the steps of:

obtaining a sealed diffusion chamber of definable configuration and internal volume, said diffusion chamber comprising at least one semi-permeable membrane and at least a suspension of viable, immunologically normal, T-cell keukocytes, said semi-permeable membrane retaining said normal, T-cell leukocyte suspension within said diffusion chamber while allowing non-cellular materials and fluids to pass therethrough, said T-cell keukocytes in said suspension being demonstratably able to provide normal T-cell functions and to produce normal, non-antibody, T-cell secretory products within said diffusion chamber;

implanting said sealed diffusion chamber at a preselected site within the afflicted subject; and

allowing the non-cellular materials and fluids of the afflicted subject to pass through said semi-permeable membrane and to interact with said normal T-cell keukocyte suspension within said implanted diffusion chamber, said interaction yielding an in-situ production and release of normal, non-antibody, T-cell secretory products from said leukocyte suspension sufficient to therapeutically treat the immunological abnormality of the afflicted subject.

2. The method as recited in claim 1 wherein said leukocyte suspension comprises mixed circulating white blood cells.

3. The method as recited in claim 1 wherein said leukocyte suspension comprises unselected T-cells.

4. The method as recited in claim 1 wherein said leukocyte suspension comprises specific T-cell subpopulations.

5. The method as recited in claim 1 wherein said leukocyte suspension comprises cloned T-cells.

6. An in-situ immunological method for treating diabetes, comprising:

obtaining a sealed diffusion chamber of definable configuration and internal volume, said diffusion chamber comprising at least one semi-permeable membrane and at least a suspension of viable, immunologically normal, T-cell leukocytes, said semi-permeable membrane retaining said normal, T-cell leukocyte suspension within said diffusion chamber while allowing non-cellular materials and fluids to pass therethrough, said T-cell leukocytes in said suspension being demonstrably able to provide normal T-cell functions and to produce normal, non-antibody, T-cell secretory products within said diffusion chamber;

implanting said sealed diffusion chamber at a preselected site within the afflicted subject; and

allowing the non-cellular materials and fluids of the afflicted subject to pass through said semi-permeable membrane and to interact with said normal T-cell leukocyte suspension within said implanted diffusion chamber, said interaction yielding an in-situ production and release of normal, non-antibody, T-cell secretory products from said leukocyte suspension sufficient to therapeutically treat the immunological abnormality of the afflicted subject.

7. An implantable immunological article for therapeutic treatment of disorders and disease states which are characterized by the presence of immunologically abnormal leukocytes in the body of an afflicted subject, said article comprising:

a sealed diffusion chamber of definable configuration and internal volume, said diffusion chamber comprising at least one hollow-fiber semi-permeable membrane able to retain at least a suspension of viable, immunologically normal, T-cell keukocytes within said internal volume of said chamber while allowing non-cellular materials and fluids to pass therethrough; and

at least a suspension of viable, immunologically normal T-cell leukocytes within said sealed diffusion chamber, said T-cell leukocytes being non-antibody producing cell demonstrably able to provide normal T-cell functions and to produce normal, non-antibody, T-cell secretory products within the non-cellular materials and fluids of the afflicted subject sufficient to therapeutically treat the immunological abnormality after implantation of said sealed diffusion chamber at a preselected site within the afflicted subject.

8. The implantable article as recited in claim 7 further comprising a plurality of said sealed diffusion chambers.

9. The article as recited in claim 7 wherein said leukocyte suspension comprises a mixture of circulating white blood cells.

10. The article as recited in claim 7 wherein said leukocyte suspension comprises unselected T-cells.

11. The article as recited in claim 7 wherein said leukocyte suspension comprises specific T-cell subpopulations.

12. The article as recited in claim 7 wherein said leukocyte suspension comprises cloned T-cells.