Chemistry: molecular biology and microbiology – Animal cell – per se ; composition thereof; process of... – Primate cell – per se
Reexamination Certificate
1998-09-18
2001-02-06
Hauda, Karen M. (Department: 1632)
Chemistry: molecular biology and microbiology
Animal cell, per se ; composition thereof; process of...
Primate cell, per se
C435S372000, C435S375000, C424S093100
Reexamination Certificate
active
06184033
ABSTRACT:
FIELD OF THE INVENTION
This invention relates, generally, to medicine, and particularly to cell therapy, and can be applied for treating diseases caused by metabolism, hemopoietic, immunity disorders e.g. AIDS (HIV-infection).
BACKGROUND OF THE INVENTION
In recent years, a striking progress has taken place in the studies and application of human fetal cadaver tissues. 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 medicinal preparations based on fetal cell suspensions and prepared from fetal tissues. By using cell suspensions prepared from fetal embryo tissues, it is possible to attain such conditions where embryo cells administered to the organism of a patient may survive, locate their respective target organs and produce descendants, thereby filling deficient functional units of organs and tissues.
Embryo cells are often capable of migrating, establishing intercellular links, proliferating, differentiating, and responding to effects. They can produce considerable amounts of biologically active substances, e.g. hemopoietic growth factors, interleukins, nerve growth factor, allogenic and neurotrophic factors etc. Embryo cells cause a weaker immune response than mature cells due to the late expression of the main antigens in the process of their maturation. Embryo cell suspensions contain much lower amounts of highly active cells such as leukocytes, endothelium of vessels, dendritic cells etc. During the early fetal period transplants do not have mature lymphocytes, and are tolerant to recipient's tissues.
The vital potential of various Fetal Cells and Tissues generate curative effects. Main of these effects are: recovery the suppressed hematopoiesis (normalization of the quantity of erythrocytes, leukocytes, lymphocytes, thrombocytes); stimulation, correction or suppression of the immune system; normalization of homeostasis (glycemia, lipidemia, creatinemia, mineral and water metabolism, blood pressure etc.); stimulation of trophic functions.
We believed that the most expedient way of initiation our effort would comprise a model of AIDS in which various kinds of injuries to numerous systems of the human organism are manifested. In addition, penetrating of the U.S. medical market by medicinal preparation based on Fetal Cells would be the most prospective under the flag of treatment of AIDS which constitutes s considerable menace to the U.S. society and requires urgent actions aimed at saving a great number of people suffering from this disease.
We studied the impact produced by Petal Cells and revealed their powerful curative effect on various functions of organism in patients suffering from AIDS. The methods of AIDS treatment with the use of Fetal Cells, invented by the author and contributors, has been protected by U.S. Pat. No 5,811,069 [14].
However, the about mentioned application addressed not only a method of treatment but also a medicinal preparation that would combine all the advantages related to the use of living cells with convenient way of handling, intrinsic in common medicinal preparation. We managed to prepare such preparations comprising the subject of this invention. During several years we have been using it successfully in our specialized Clinic of Cell Therapy of the National Medical University, as well as in process of providing assistance to severely sick people in medical institutions of 15 reputable research institutes and specialized centers of the Academy of Medical
Science and the Ministry of public health of Ukraine in an area of treatment of numerous diseases characterized by injuries to the immune system, metabolism, and hemopoiesis. Substantiation of application of this medicinal preparation and relevant clinical examples are given hereinafter with reference to patients suffering from AIDS, wherein the inventive medicinal preparation has demonstrated its curative potential to the highest extent in case of availability of an aggravated state of numerous vital systems of the human organism.
It is a well-known fact the the destructive effect of the immune deficiency virus on the immune system starts immediately upon the moment of infection. Sensitivity to antiretroviral preparations, resistance, and capability of damaging cells are very variable among virus isolates. Numerous research workers are skeptical about the possibility of HIV elimination by using only antiretroviral preparations, probably except a short time period immediately after infection. Even if preparations result in a substantial reduction of the viral loading, the amount of lymphocyte helpers seldom comes back to the normal level. On the contrary, it usually remains over a plateau of 100 to 150/mm
3
. In addition, there may be grave and unforeseen consequences of the long-term usage of antiretroviral therapy, which fact requires effort aimed at development of “natural”, immunity-based control of HIV infection.
Although numerous studies are carried out/aimed at support and restoration of immune competence with the use of immune modulators, cytokins, growth factors, and specific immune intervention (passive immunization and vaccination), no licensed preparations are available that could restore and support immune system functions.
The progress of AIDS involves two sides:
infection with HIV, its reproduction inside organism, and attack on patient's immune system, and
increase in the activity of immune response of patient's organism, aimed at neutralizing the HIV attack, exhaustion of the functional activity of the immune system, and subsequent decrease in the production of important components of the immune system as a result of exhaustion of the leukocytic branch of hemopoiesis.
Therefore, treatment of the disease is directed at both sides of the process:
suppression of HIV reproduction with the use of antiretroviral preparations, and
strengthening (in HIV-infected and carriers) and restoration (in AIDS patients) of the functional activity of immune system, and compensation of insufficient own immune response.
At present, much success has been achieved in the suppression of HIV replication. As you know, however, this does not result in the recovery of patients suffering from AIDS and HIV-infection.
Restoration of the functional activity of immune system constitutes an independent task in the course of treatment of patients suffering from AIDS and HIV-infection.
We suppose that the most success will be attained through combination of using antiviral therapeutic means aimed at suppression of virus replication, and the inventive medicinal preparation directed at restoration of the functional activity of the patient's immune system.
In recent years, a striking progress has taken place in the studies and application of human fetal cadaver tissues. 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 medicinal preparations based on fetal medicinal preparation and prepared from fetal tissues.
By using medicinal preparation prepared from fetal embryo tissues, it is possible to attain such conditions where embryo cells administered to the organism of a patient may survive, locate their respective target organs and produce descendants, thereby filling deficient functional units of organs and tissues.
Embryo cells are often capable of migrating, establishing intercellular links, proliferating, differentiating, and responding to effects. They can produce considerable amounts of biologically active substances, e.g. hemopoictic growth factors, interleukins, nerve growth factor, allogenic and neurotrophic factors etc.
Embryo cells cause a weaker immune response than mature cells due to the late expression of the main antigens in the process of their maturation. Embryo cell suspensions contain much lower amounts of highly active cells such as leukocytes, endothelium of vessels, dendritic cells etc. During th
Abelman ,Frayne & Schwab
Centr Embrionalnikh Tkaney “Emcell”
Hauda Karen M.
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