We claim:
1. A method for treating diabetes mellitus, comprising the step of administering to a patient in need thereof a DNA segment, said DNA segment comprising an insulin gene and a promoter sequence, wherein said promoter sequence is operably linked to said insulin gene and wherein said DNA segment is effective for the expression of a therapeutically effective amount of insulin in said patient.
2. A method of claim 1 , wherein said DNA segment is injected directly into a muscle of said patient.
3. A method of claim 1 , wherein said promoter is a muscle-specific promoter.
4. A method of claim 3, wherein said promoter is MCL-1 , MCL-2, MLC-3, Creatinine kinase, Myo-D, or myogenin.
5. A method of claim 2, wherein said DNA segment is an integral part of a vector.
6. A method of claim 2, wherein said DNA segment is in a pharmaceutical preparation.
7. A method of claim 5, wherein said vector is a viral vector.
8. A method of claim 7, wherein said vector is a retroviral vector, an adenoviral vector, an adeno-associated viral vector, a sindbis viral vector, or a herpes viral vector.
9. A method of claim 6, wherein said pharmaceutical preparation is a DNA ligand conjugate, a liposome or a calcium phosphate precipitate.
10. A method of claim 1 , wherein said DNA segment is introduced to said patient in cells, said cells having being treated in vitro to incorporate said DNA segment.
11. A method of claim 10, wherein said cells are muscle cells.
12. A method of claim 1 1 , wherein said muscle cell is mouse myoblast C2C12, C3H10T1/2, rat myoblast L6, rat myoblast L8, human myoblast HISM, or a primary human myoblast.
13. A method of claim 10, wherein said cells are directly injected into a muscle of said patient.
14. A method of claim 10, wherein said cells are in a neo-organ.
15. A method of claim 10, wherein said cells are in a alginate microcapsule.
16. A method of claim 10, wherein said cells are in an immuno-privileged cell factory.
17. A method of claim 10, wherein said DNA fragment has been incorporated into said cells by DNA-mediated transfection.
18. A method of claim 10, wherein said DNA fragment has been incorporated into said cells by viral infection.