Pharmaceutical preparation based on fetal suspension and methods

Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing

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Details

424 9321, 435325, C12N 508, A61K 3800, A61K 3900

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active

058110895

DESCRIPTION:

BRIEF SUMMARY
FIELD OF THE INVENTION

This invention relates, generally, to medicine, and particularly to cell therapy, and can be applied for treating the acquired immune deficiency syndrome (HIV infection), as well as other diseases caused by occurrence of immune deficiencies.


BACKGROUND OF THE INVENTION

In recent years, a striking progress has taken place in the studies of human fetal cadaver tissues application. A completely new area of therapy is being developed, i.e. cell therapy that permits to fill an insufficient functional activity of damaged and sore tissues through the application of cell suspensions prepared from fetal tissues. Cell transplantation appears to be an attractive alternative for transplanting organs and tissues, since advantages of embryonic cells consist in the fact that they have not formed any strong individual characters of antigenic histocompatibility, are readily engrafted and do not induce the reaction of transplants against the host. In addition, cells feature a powerful vital potential. They proliferate, differentiate, and constitute a source of a vast number of biologically active substances.
At present, applied are cell suspensions prepared from fetal brain, bone marrow, liver, spleen, thymus, pancreas, and culocutaneous graft.
They are used for treatment of blood diseases such as primary and secondary myelodepressive states, immunity disorders, neural diseases, sugar diabetes etc.
The most successful initial attempts to apply cell suspensions as medicinal preparations involved human fetal liver.
In 1973, a medicinal preparation based on the cell suspension of native cells of a fetal liver of a 7-week gestation was prepared for the first time; administration of this preparation resulted in the recovery of hemopoiesis in a patient suffering from aplastic anemia (Kelemen E. Second J. Gematol., 1973, v. 10, No.4, pp.305-308).
In recent years, by varying methods of preparing cell suspensions and procedures of their application, research workers managed to achieve positive results of treating primary and secondary myelodepressive states (Lucarelli G., Izzi T., Porcelini A. Fetal liver transplantation. Alan R. Liss, 1985, pp.237-249).
A promising area of the clinical application of the above cell suspensions comprises immunity disorders, particularly in case of grave combined immune deficiency. Here, the most extensive clinical experience has been accumulated by Touraine J. L. (202 transplantations)--Transplantation Proceedings, 1993, v.25, No. 1, pp. 1067-1078.
At present, in the paper presented by Bacchetta R., Roncarolo M. J., Touraine J. L. Clin. Invest., 1993, v.91, March, pp.1067-1078) demonstrated are end results of treating two patients suffering from grave combined immune deficiency; here, not only immunity indices have been recovered in patients, but also presence of split chimerism and emergence of tolerance to both host and donor antigens have been demonstrated.
The authors of the present invention also have their own experience of using cell suspensions for treatment of immune disorders in cases of blood diseases.
The authors however do not have any information about application of these preparations for treatment of patients suffering from HIV infection (AIDS).
One of the most important mechanisms of HIV infection consists in a specific interaction between the HIV tunica albuginea (dr 120) and CD.sub.4 protein expressed on the surface of immune cells pertaining to the T.sub.4 lymphocytes class (helpers/inductors). The amount of cells carrying CD.sub.4, CD.sub.8, and CD.sub.12 considerably decreases; CD.sub.4 /CD.sub.8 ratio changes; a polyclonal stimulation of B lymphocytes and plasma cells is observed; activity of the mononuclear-macrophagal system reduces; amounts of NK and DN cells decreases.
In patients suffering from AIDS, hematologic disorders are observed, caused by the direct suppression of hemopoiesis by HIV infection, and resulting from medicamental effects, infiltrative processes of inflammatory, infectious or neoplastic nature. These disorders result in lymphop

REFERENCES:
patent: 3937816 (1976-02-01), Jaeger et al.
patent: 4088753 (1978-05-01), Parmer
patent: 4271148 (1981-06-01), Keeling
Touraine et al. "Fetal liver transplantation: Biology and clinical results," Bone Marrow Transplant, vol. 11:119-122, Nov. 1993.
Izzi et al. "Fetal Liver Transplant in A Plastic Anemia and Acute Leukemia", Fetal Liver Transplantation, 237-249 (1985).
Hassett et al., "Bone Marrow Transplantation in Aids", New England J. of Med., vol. 309, No. 1, p. 665 (1983).

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