Method of increasing immunological effect

1. A method of increasing immunological effect in a patient, including the steps of:

administering an effective amount of a primary cell derived biologic IRX-2 to the patient;

inducing immune production;

blocking immune destruction;

increasing immunological effect in the patient; and

measuring up-regulated expression of anti-apoptotic signaling molecules and down-regulated expression of pro-apoptotic molecules indicating the protection of T cells from apoptosis, confirming that immunological effect is increased.

2. The method of claim 1 , wherein said inducing and blocking steps are further defined as potentiating the cellular and humoral multiple arms of a patient's immune system.

3. The method of claim 2 , wherein said potentiating step is further defined as

restoring naive T cell populations;

activating T and B cells;

promoting infiltration of leukocytes into and adjacent to an immune target; and

extending the duration of immune response.

4. The method of claim 1 , wherein said inducing step is further defined as

maturing immature dendritic cells, the resulting mature dendritic cells activating naive T cells, modifying populations of B and T cells in blood, activating regional lymph nodes, infiltrating an area adjacent to an immune target with T helper and B cells, and infiltrating the immune target with T killer cells and macrophages; and

wherein said blocking step is further defined as protecting the activated naive T cells from apoptosis.

5. The method of claim 4 , wherein said modifying step is further defined as up-regulating or down-regulating the populations of B and T cells in blood.

6. The method of claim 5 , wherein said modifying step is further defined as modifying populations of naive T cells and early memory T cells.

7. The method of claim 6 , wherein said modifying step is further defined as modifying CD3+, CD45RA+, and CCR7+ naive T cell populations.

8. The method of claim 7 , wherein said modifying step is further defined as differentiating the naive T cells into memory and effector T cells.

9. The method of claim 8 , further including the step of causing central memory T cells to exit the bloodstream and migrate to draining lymph nodes.

10. The method of claim 6 , wherein said modifying step is further defined as causing the B cells to be recruited into lymph nodes, exposing the B cells to antigen, migrating the B cells to the immune target, and attacking the immune target.

11. The method of claim 10 , wherein said attacking step is further defined as an action chosen from the group consisting of producing antibodies that attack the immune target, and supporting antibody-dependent cellular cytotoxicity.

12. The method of claim 4 , wherein said activating regional lymph nodes step is further defined as enlarging the regional lymph nodes, replenishing lymphocytes, and reversing sinus histiocytosis.

13. The method of claim 4 , wherein said infiltrating the area adjacent to the immune target step is further defined as infiltrating the area adjacent to the immune target with CD45RA+, CD3+, and CD4+T lymphocytes and CD20+B lymphocytes.

14. The method of claim 4 , wherein said infiltrating the immune target step is further defined as infiltrating the immune target with CD45RO+, CD3+, and CD8+ lymphocytes and CD68+ macrophages.

15. The method of claim 4 , wherein said infiltrating the area adjacent to the immune target step and said infiltrating the immune target step produce humoral and cellular immunity.

16. The method of claim 4 , wherein said protecting step is further defined as up-regulating the expression of anti-apoptotic signaling molecules and down-regulating the expression of pro-apoptotic molecules.

17. The method of claim 16 , wherein said up-regulating step is further defined as up-regulating the expression of JAK-3 and phosphor-Akt, and said down-regulating step is further defined as down-regulating SOCS-2.

18. The method of claim 4 , wherein said protecting step is further defined as decreasing caspase activation in CD8+ and CD4+T lymphocytes.

19. The method of claim 4 , wherein said protecting step is further defined as increasing cFLIP expression.

20. The method of claim 4 , wherein said protecting step is further defined as protecting activated T cells from extrinsic apoptosis and intrinsic mitochondrial apoptosis.

21. The method of claim 20 , wherein said protecting activated T cells from extrinsic apoptosis step is further defined as protecting activated T cells from microvesicle (MV)-induced and FasL-induced apoptosis.

22. The method of claim 21 , wherein said protecting activated T cells from MV-induced apoptosis step is further defined as preventing down-regulation of JAK3, CD3-.zeta., and STAT5.

23. The method of claim 21 , wherein said protecting activated T cells from MV-induced apoptosis step is further defined as inhibiting dephosphorylation of Akt-1/2.

24. The method of claim 21 , wherein said protecting activated T cells from MV-induced apoptosis step is further defined as maintaining balanced ratios of Bax/Bcl-2, Bax-Bcl-xL, and Bim/Mcl-1.

25. The method of claim 21 , wherein said protecting activated T cells from MV-induced apoptosis step is further defined as preventing induction of the activity of caspase-3 and caspase-7.

26. The method of claim 25 , wherein said preventing induction step is further defined as blocking induction of an active cleaved form of caspase-3.

27. The method of claim 25 , wherein said preventing induction step is further defined as blocking loss of mitochondrial membrane potential.

28. The method of claim 21 , wherein said protecting activated T cells from MV-induced apoptosis step is further defined as reducing nuclear DNA fragmentation.

29. The method of claim 20 , wherein said protecting activated T cells from intrinsic apoptosis step is further defined as protecting activated T cells from staurosporine-induced apoptosis.

30. The method of claim 1 , wherein said administering step further includes administering low dose cyclophosphamide prior to administering the IRX-2 and further includes the step of reversing suppression by T regs lymphocytes.

31. The method of claim 30 , wherein said administering step further includes administering indomethacin and zinc daily.

32. The method of claim 30 , wherein said administering step is further defined as subcutaneously administering IRX-2 daily or intermittently 3 days a week 5 out of 7 days for 5 to 20 days.

33. The method of claim 32 , wherein said administering step is further defined as administering 30 to 700 Units of IRX-2 per day.

34. The method of claim 1 , further including the step of administering exogenous antigen.

35. The method of claim 1 , further including the step of performing surgery, radiotherapy, chemotherapy, or combinations thereof.

36. The method of claim 3 , wherein the immune target is a biological condition caused by the group consisting of genetic defects, cancer, infections, malnutrition, burns, AIDS, HIV, chemotherapy, and radiotherapy.

37. The method of claim 1 , wherein the patient is immune incompetent and said increasing step is further defined as reversing immune incompetence in the patient.