RU2026643C1 - Method for treating male patients suffering from deranged sexual function by method of transplantation - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: this method prescribes introducing Leydig's cells (embryonal testicular tissue cells) to be taken in amount of at least 2 mln cells per 1 ml under testicle tunic albuginea. EFFECT: promising results. 1 tbl

Description

 The invention relates to medicine and for the treatment of patients with impaired male sexual function.

 The most typical manifestations of dysfunction of the organs of the male genital area are impotence and male infertility, one of the main reasons for which can be violations of spermatogenesis and androgen deficiency - a reduced level of male sex hormones.

 Such violations can be primary in nature or appear again as consequences of other pathologies, in particular prostatitis or sexually transmitted diseases.

 In terms of severity of adverse social consequences, the World Health Organization posed the problem of male infertility immediately after the problems of cancer and cardiovascular diseases.

 The tactics of treating specific disorders of male sexual function is determined by the nature and severity of the pathology, the characteristics of the physical and mental status of the patient, and is often symptomatic.

 The most common method for the treatment of androgen deficiency is the introduction of androgen hormones, primarily testosterone and its synthetic analogues, into the body.

 However, in most cases, hormone therapy does not lead to a complete restoration of normal reproductive function and the treatment is surviving in nature, which does not eliminate the cause of the disease.

 Also known is a method of treating androgen deficiency in secondary hypogonadism by transplantation of a pituitary-hypothalamic complex into a patient.

 The practical complexity of such operations, which require, in particular, hard-to-reach cadaveric or donor material, is clear.

 Closest to the proposed technical essence is the method of treatment of androgen deficiency, which consists in transplanting a patient a donor testicle on vascular connections.

 The method gives good results, but has certain disadvantages associated with large surgical operations and the need for immunosuppressive therapy. In addition, the need to use cadaveric or donor material creates additional difficulties.

 The aim of the invention was to develop a method for the treatment of patients with impaired male sexual function, including male infertility and impotence, mainly associated with androgen deficiency of any etiology, which allows, in particular, to stabilize the physiologically acceptable level of androgen hormones in the human body.

 This goal was achieved by implanting a suspension of viable Leydig cells under the human testicle.

 The essence of the proposed method is as follows.

 A suspension of viable Leydig cells — cells of testicles of a cow, pig, or human embryo — is preliminarily prepared.

 Leydig cells of any origin can be used, since the embryonic tissue does not cause a rejection reaction during transplantation.

 To prepare the suspension, an isotonic solution must be used to avoid osmotic effects, however, it is most advisable to use solutions containing a nutrient substrate for cells, in particular, compositions of standard media for animal tissue cells - Eagle’s media, Hanks’s solution, 199 medium and the like. The desired density of the suspension is at least 2 million cells in 1 ml. All procedures for the preparation of the suspension should be carried out under aseptic conditions, and the suspension itself must be sterile. Under local anesthesia, for example, using chloroethyl, the suspension is injected under the testicle. The effective dose has an order of at least 2 million cells. It is advisable to administer this dose in a volume not exceeding 1 ml so as not to cause excessive tissue trauma and pain. The treatment procedure is technically easy and can even be performed on an outpatient basis. The method has no contraindications, does not give complications.

 In cases where the Leydig cells in the patient have lost their normal ability to produce testosterone, the implantation of Leydig donor cells has a twofold effect - independently developing, the implanted cells produce testosterone entering the bloodstream; coming into contact with the host cells, the implanted cells stimulate their full development and functioning. It can be assumed that viable and complete implantable cells can replace defective host cells, at least in part.

 The practical implementation of the method does not require the use of immunosuppressive drugs.

 A large volume of experiments allows us to conclude that in 98% of cases, Leydig cells injected under the testicle are capable of fixing in a new medium and actively multiply.

 In those cases when the cells of the host testicles have completely lost their viability, injections of suspension cells can be repeated periodically and the physiological effect of their action can be provided due to the testosterone synthesized by them.

 The effectiveness of the proposed method was confirmed by experiments on animals and in experiments on volunteers.

 In particular, data on the effectiveness of the proposed method in experiments on partially castrated male rats are shown in the table.

 The results obtained indicate that the implantation of Leydig cells provides a quick and high rise in testosterone levels in the blood. In animals to which Leydig cells were not administered, the concentration of testosterone remained trace.

 In experiments on volunteers, a few days after the operation, an increase in the level of testosterone in the blood and a significant improvement in subjective sensations were noted - the appearance of pollutions, spontaneous and adequate erections. During the observation period, an increase in testicles in size, an increase in their density, an increase in turgor and a decrease in the scrotum folding, an increase in the number of spermatozoa with a simultaneous increase in their motility were recorded.

 A single implantation of Leydig cells provides a lasting effect for up to 1 year (observation period).

 An analysis of the patent and scientific and technical literature showed that there is no information on the use of Leydig cells for the successful treatment of androgen deficiency in humans, and the applicant therefore believes that the proposed method meets the requirements of the invention.

 PRI me R 1. Patient N., 35 years. Four years ago, azoospermia was diagnosed. Treatment according to the traditional regimen - Sustanonum and the drug CG intramuscularly - was ineffective. The content of testosterone in the blood is 4.8 mmol / L.

 After revision of the reproductive tract, 2 million Leydig cells were introduced under the testicle.

 After 10 days, 1-2 live spermatozoa were detected in the spermatogram in the field of view, the testosterone content in the blood was 12.4 mmol / L. When re-examined after 1 month on the spermatogram - 4-6 live sperm in the field of view, the level of testosterone - 20.1 mmol / L. After 6 months, 10-12 live sperm cells were observed in the field of view and 26.6 mmol / L of testosterone.

 PRI me R 2. Patient A., 56 years. He was admitted with complaints of a lack of adequate and spontaneous erections, irritability, fatigue, insomnia. The diagnosis was age-related erectile dysfunction of the reproductive tract in the absence of a vascular component, neurocircular dystonia. The content of testosterone in the blood is 1.43 mmol / L.

 Conducted complex therapy - speman, testobromlycin, pantocrine - did not give a positive result.

 Under the protein coat of both testicles, 2 million Leydig cells were introduced. After 7 days, pollutions were noted, the content of testosterone in the blood rose to 5.2 mmol / L. After 10 days, the appearance of spontaneous erections was noted, the content of testosterone in the blood increased to 7.4 mmol / L. After 1 month, the testosterone level in the blood was 10.2 mmol / L.

 PRI me R 3. Patient A., 40 years old, married 12 years. Received complaints of infertility. The diagnosis is oligoastenozoospermia.

 The wife is gynecologically healthy.

 Spermatogram upon admission: sperm volume 3.5 ml, pH 7.6, color - grayish, consistency - viscous, liquefaction 10 min. In 1 ml of ejaculate, 1 million sperm. In the field of view - 1-2 motile spermatozoa, 5-7 spermatogenesis cells, 80-100 white blood cells, 1-3 red blood cells. LH 8.6 mU / ml, FSH 2.47 mU / ml. The content of testosterone is 9.3 mmol / L.

 In a hospital, 3 million Leydig cells were introduced under the protein membrane of both testicles. No postoperative complications were observed.

 3 months after the treatment: sperm volume 3.5 ml, pH 7.5, color - grayish, consistency - viscous, liquefaction 10 min. In 1 ml of ejaculate, 48 million sperm. In the field of view, 70% of motile sperm cells after 15 minutes and 50% after 30 minutes. LH 3.6 mU / ml, FSH 2.47 mU / ml. The content of testosterone is 18.7 mmol / L.

 PRI me R 4. Patient S., 29 years old. He was admitted with a diagnosis of erectile dysfunction. The content of testosterone is normal; spermatogram is normal.

 Under the protein membrane of both testicles, 3 million Leydig cells were introduced.

 After 3 days, there was a subjective improvement, there were pronounced erections, adequate libido.

 Thus, the presented results show the high efficiency of the proposed method, contributing to the normalization of testosterone levels in the blood (7-35 mmol / l) on average on the tenth day after implantation of Leydig cells. The obvious advantages of the proposed method over the known ones are its extreme simplicity in the absence of contraindications for its implementation.

 The method is indicated for the treatment of various forms of male sexual dysfunction.

Claims (1)

 METHOD FOR TREATING PATIENTS WITH DISTURBANCES OF THE MALE GENITAL FUNCTION BY THE METHOD OF TRANSPLANTATION, characterized in that viable Leydig cells of embryonic origin are transplanted under the testicle in a dose of at least 2 million cells per 1 ml.

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