JP2021080255A - Agent for erectile dysfunction treatment, method for producing the same and instrument for erectile dysfunction treatment - Google Patents

Abstract

To provide an agent for erectile dysfunction (ED) treatment that can be delivered to the cavernous body of a penis with a needleless syringe, and a method for producing the agent for ED treatment and an instrument for ED treatment.SOLUTION: An agent for ED treatment (10) contains a supernatant (3) obtained from a liquid culture medium, in which a stem cell (1) was cultured and recovered. Or, in the agent for ED treatment (10), the supernatant (3) is mixed with a prostaglandin preparation or a PDE5 inhibitor (4).SELECTED DRAWING: Figure 1

Description

The present invention relates to the treatment of erectile dysfunction (ED). More specifically, the present invention relates to ED therapeutic agents and therapeutic instruments.

As a conventional ED treatment, for example, there is a method of administering a prostaglandin E1 preparation to the corpus cavernosum of a male genitalia. When the prostaglandin E1 preparation is administered to the corpus cavernosum of the male genitalia, it is injected (injected) into the male genitalia of the patient by a syringe.
Here, since injection into a male vessel using a normal syringe causes great pain, it is conceivable to use a needleless syringe without a needle when administering the prostaglandin E1 preparation.
However, when the prostaglandin E1 preparation is administered using a needleless syringe, it is highly probable that the prostaglandin E1 preparation does not reach the corpus cavernosum of the male genitalia. Since the corpus cavernosum of the male genitalia is covered with the corpus cavernosum, it is highly possible that the prostaglandin E1 preparation does not penetrate the corpus cavernosum and does not reach the corpus cavernosum when administered using a conventional needleless syringe. .. In Experimental Example 3 described later, the effect of administration of the prostaglandin E1 preparation was not exhibited in 2/3 of the subjects, which also supports the estimation.

As another prior art, a fat emulsion containing a compound having prostaglandin E1 activity has been proposed (see Patent Document 1).
However, according to the above-mentioned prior art (Patent Document 1), there is a high possibility that the prostaglandin E1 preparation does not reach the corpus cavernosum of the male genitalia when the prostaglandin E1 preparation is administered using a needleless syringe. It is not intended to solve the problem.

Japanese Unexamined Patent Publication No. 2014-224131

The present invention has been proposed in view of the above-mentioned problems of the prior art, and is an ED therapeutic agent capable of reaching the corpus cavernosum of a male genitalia even when a needleless syringe is used, and an ED therapeutic agent thereof. The purpose is to provide a manufacturing method for ED and an instrument for treating ED.

The ED therapeutic agent (10) of the present invention contains (or consists of only the supernatant 3) the supernatant (3) obtained from the liquid medium after culturing and collecting the stem cells (1). It is a feature.
In the ED therapeutic agent (10) of the present invention, the supernatant (3) may be mixed with a prostaglandin preparation or a PDE5 inhibitor (4: phosphodiesterase-5 inhibitor).
Here, the supernatant (3) is obtained by culturing the stem cells (1) in the liquid medium (2) and filtering the liquid medium (2) after collecting the cultured stem cells (for example, pore size 0.2 μm or more). It can be obtained by passing it through a 0.45 μm filter) to remove impurities such as cells, allowing it to stand, and separating it from the precipitate. The supernatant (3) does not include a component (so-called "miscellaneous taste component" such as an inhibitor) contained in cells or a cell disruption solution, which has an inappropriate action for ED treatment.

Then, in the method for producing the ED therapeutic agent (10) of the present invention, the stem cells (1) are cultured in the liquid medium (2), and the liquid medium (2) after collecting the cultured stem cells is filtered (for example, pores). It has a step of removing impurities such as cells through a filter having a size of 0.2 μm to 0.45 μm), removing the impurities, and then allowing the mixture to stand to separate it from the precipitate to obtain the supernatant (3). It is characterized by.
The method for producing the ED therapeutic agent (10) of the present invention can include a step of mixing the supernatant (3) with a prostaglandin preparation or a PDE5 inhibitor (4).

Further, in the ED treatment device (11) of the present invention, the ED treatment drug (10) containing the supernatant (3) obtained from the liquid medium after culturing and collecting the stem cells (1) is ampoule ( It is characterized in that it is filled in 12).
In the ED therapeutic device (11) of the present invention, the ampoule (12) is filled with the ED therapeutic agent (10) in which the supernatant (3) and the prostaglandin preparation or the PDE5 inhibitor (4) are mixed. Is preferable.

In the present invention, it is preferable to use the prostaglandin E1 preparation (4) as the prostaglandin preparation or the PDE5 inhibitor (4).
Then, the supernatant (3) is filled with an ampoule (12) to inject (supply) a prostaglandin preparation or a PDE5 inhibitor (4) into the corpus cavernosum (21), and the stem cells (1) of the patient himself / herself are to be injected (supplied). Even the supernatant (3) of the liquid medium (2) after culturing and collecting is the supernatant (3) of the liquid medium (2) after culturing and collecting the stem cells (1) of another person. You may.

The ED therapeutic agent (10) of the present invention is preferably used in the treatment of supplying the agent into the body of a patient without using a needle syringe.
Further, the ED therapeutic agent (10) of the present invention is preferably used when performing an extracorporeal shock wave therapy method.

According to the ED therapeutic agent (10) and the ED therapeutic instrument (11) of the present invention having the above-mentioned configurations, the cavernous body of the male genitalia is surely reached, and a significant effect is brought about in the patient suffering from ED. This has been confirmed by the inventor's experiments. The ED therapeutic agent (10) of the present invention is mixed with a supernatant (3) obtained from a liquid medium obtained by culturing and collecting stem cells (1), and the supernatant is obtained from the male genitalia (20). Since it easily penetrates the white membrane (22) that covers the corpus cavernosum (21), it surely reaches the corpus cavernosum (21) when injected into the male genitalia (20).
Here, various proteins and other components (so-called “active ingredients”) useful for ED treatment and the like are secreted in large quantities from the cultured stem cells when the stem cells are cultured in the liquid medium, so that the liquid medium in which the stem cells are cultured is secreted in large quantities. Contains a large amount of active ingredients. Then, the supernatant (3) is collected by culturing the stem cells (1) in the liquid medium (2), and then the liquid medium (2) is passed through a filter to remove impurities, and the supernatant (3) is allowed to stand to separate from the precipitate. Since it is obtained by the above, it contains a large amount of active ingredients. Therefore, the supernatant (3) contains various proteins and other components (so-called "active ingredients"), and such active ingredients are supplied to the corpus cavernosum (21). According to (10), the ED treatment effect is improved.

In the present invention, if the supernatant (3) is mixed with the prostaglandin preparation or PDE5 inhibitor, the prostaglandin preparation or PDE5 inhibitor (4) is surely transferred to the corpus cavernosum (21) together with the supernatant (3). Estimated to reach. Therefore, the ED treatment efficiency is further improved by the medicinal effect of the prostaglandin preparation or the PDE5 inhibitor (4).
Since the ED treatment device (11) of the present invention is filled with the above-mentioned ED treatment drug (10) in the ampoule (12), the ED treatment device (11) of the present invention is used to treat the patient. When injected into the corpus cavernosum (20), the action of the stem cells (1) and the supernatant (3) after culturing contained in the filled drug (10) for treating ED of the present invention inhibits the prostaglandin preparation or PDE5. It is presumed that the agent (4) or the ED therapeutic agent (10) permeates the white membrane (22) of the corpus cavernosum (21) and surely reaches the corpus cavernosum (21).
Here, since the cells themselves do not permeate the white membrane, even if a drug solution made from cells or cell crushed liquid is injected into the male genitalia (20), it permeates the white membrane (22) that covers the corpus cavernosum (21). It is difficult for the drug solution made from cells or cell crushed solution to reach the corpus cavernosum (21). Therefore, the above-mentioned effects of the present invention cannot be expected.

When a drug solution is prepared using a cell disruption solution as a raw material, the protein is destroyed when the cells are disrupted and the active ingredient is destroyed, so that the active ingredient secreted by the stem cells cannot be included. It does not work effectively with ED treatment. On the other hand, when the supernatant (3) is obtained, the proteins and the like contained in the liquid medium (2) after culturing are not destroyed. Therefore, according to the present invention, the active ingredient secreted by the stem cells is used. It can be used efficiently.
Further, since the supernatant (3) does not contain miscellaneous components such as inhibitors contained in stem cells, unlike the case where a crushed solution or the like is used as a raw material, according to the present invention, the effect of ED treatment is due to the miscellaneous components such as inhibitors. Is not impaired.

As described above, the supernatant (3) is obtained by culturing not only the supernatant (3) obtained by culturing the stem cells (1) of a patient to be injected into the corpus cavernosum (21) but also the stem cells (1) other than the patient. It has been found in the inventor's experiment that the supernatant (3) may be used after the injection. In other words, according to the inventor's experiment, even if a culture solution supernatant (3) after culturing another person's stem cell (1) is mixed with a prostaglandin preparation or a PDE5 inhibitor (4) and injected. , It has been confirmed that no rejection is seen. It is presumed that the culture supernatant (3) after culturing the stem cells (1) of another person does not include the tissue of the other person, and therefore the rejection reaction does not occur.
Therefore, according to the present invention, the ED therapeutic agent (10) can be reliably reached to the corpus cavernosum (21) even when the stem cells (1) of the ED patient himself / herself are not cultured.

When the ED therapeutic agent (10) of the present invention is used in the treatment of supplying the ED therapeutic agent (10) into the patient's body without using a needle syringe, the supernatant becomes a white film covering the body tissue (for example, the corpus cavernosum 21) as described above. Since it easily penetrates (22 etc.), the drug (10) surely reaches the subcutaneous part of the patient (or the corpus cavernosum 21 of the patient) as in the case of using a needle syringe, which is suitable.
Treatments that supply the drug into the patient's body without using a needle syringe include, for example, a treatment in which the drug is injected into the patient using an innocent syringe, a method in which the drug is injected subcutaneously into the patient using a microneedle, and the like. There is a method (electroporation: electric perforation method) in which a drug is administered by temporarily opening a gap that reaches the deep layer of the skin by electricity.
Compared with the method of injecting a drug subcutaneously into a patient using a microneedle, a treatment or electroporation method in which a drug is injected into a patient using an innocent syringe is preferable because of its good medical efficiency.

The supernatant contained in the ED therapeutic agent (10) of the present invention, that is, the supernatant obtained from the liquid medium after culturing and collecting the stem cells (1), can satisfactorily exhibit the blood vessel regeneration ability. Are known. Therefore, if the present invention containing the supernatant (3) obtained from the liquid medium after culturing and collecting the stem cells (1) as a raw material is used in combination with the extracorporeal shock wave therapy method, the regeneration efficiency of blood vessels in the body tissue of the patient Is improved, and the therapeutic effect in the extracorporeal shock wave treatment method is also improved.

It is explanatory drawing which shows the outline of the manufacturing process of the ED therapeutic agent which concerns on embodiment of this invention. It is explanatory drawing which shows the procedure which makes the ED treatment instrument which concerns on embodiment usable. It is explanatory drawing which shows the use state of embodiment.

Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings.
The ED therapeutic agent 10 according to the illustrated embodiment is composed of the supernatant 3 after culturing the stem cells 1. Alternatively, it is produced by mixing the supernatant 3 with a prostaglandin preparation or a PDE5 inhibitor 4. In the illustrated embodiment, the prostaglandin E1 preparation is particularly suitable as the prostaglandin preparation or the PDE5 inhibitor 4.
The procedure for producing the ED therapeutic agent 10 according to the illustrated embodiment will be described with reference to FIGS. 1 (A) to 1 (D).

First, as shown in FIG. 1A, the culture vessel 5 is filled with medium 2 which is a liquid medium, and stem cells 1 collected from a patient are cultured in the medium 2. As the medium 2 which is a liquid medium, a commercially available product can be used.
The stem cells 1 to be cultured are adipose-derived mesenchymal stem cells, umbilical cord and cord blood-derived mesenchymal stem cells, dental pulp-derived mesenchymal stem cells, or bone marrow-derived mesenchymal stem cells. However, other stem cells are also possible. Further, it has been confirmed by the inventor's experiment that the collected stem cell 1 may be a stem cell of a patient to which the drug 10 for ED treatment is administered or a stem cell collected from another person. ..
Next, as shown in FIG. 1 (B), the cultured stem cells 1 are collected from the culture vessel 5, and then the medium 2 is passed through a filter (not shown) having a pore size of 0.2 μm to 0.45 μm. The supernatant 3 (see FIG. 1 (C)) is obtained by removing impurities such as cells and allowing the cells to stand to separate from the precipitate (not shown). That is, the supernatant 3 is obtained from the liquid medium after culturing and collecting the stem cells (1).

The obtained supernatant 3 can be used as it is as the drug 10 for ED treatment.
Alternatively, as shown in FIG. 1C, the supernatant 3 is mixed with the prostaglandin preparation or the PDE5 inhibitor 4 in a drug storage container 7 separate from the culture container 5 to prepare an ED therapeutic drug 10. ..
When mixing the supernatant 3 with the prostaglandin preparation or PDE5 inhibitor 4, if the supernatant is too small for the prostaglandin preparation or PDE5 inhibitor, the prostaglandin preparation or PDE5 inhibitor does not penetrate the white membrane. An event that is presumed to occur occurs. On the other hand, if the supernatant is too large, the absolute amount of the prostaglandin preparation or the PDE5 inhibitor may be insufficient.

In the illustrated embodiment, the culture solution supernatant 3 after culturing the stem cell 1 of the person receiving the ED treatment is used, but the culture solution supernatant 3 after culturing the stem cell 1 of another person is also used. It has been confirmed by the inventor's experiment that no rejection reaction or the like occurs even if the ED therapeutic agent 10 according to the embodiment is administered. It is presumed that the culture supernatant 3 after culturing the stem cells 1 of another person did not include the tissue of the other person, and therefore the rejection reaction did not occur.
When the prostaglandin preparation or the prostaglandin E1 preparation is selected as the PDE5 inhibitor, the prostaglandin E1 preparation includes a liquid product and a dry-frozen product. If it is a liquid prostaglandin E1 preparation, it is mixed with the supernatant 3 in the manner shown in FIG. 1 (C) and filled in the ampoule 12 as described in FIG. 2 (A). On the other hand, in the case of a dry-frozen prostaglandin E1 preparation, the prostaglandin preparation such as a vial is dissolved in the supernatant 3, and the solution containing the supernatant and the prostaglandin is sucked into the ampoule 12. Alternatively, as shown in FIG. 1 (D), a predetermined amount of a dry-frozen prostaglandin E1 preparation (indicated by reference numeral PE1) is previously contained in an ampoule, and the supernatant 3 is placed in the ampoule 12 with a needleless injection needle. You may inhale and mix the dry-frozen prostaglandin E1 preparation in the ampoule 12.

Next, with reference to FIGS. 2 (A) to 2 (C), a procedure of filling the ampoule 12 with the ED therapeutic agent 10 to make the ED therapeutic instrument 11 usable will be described.
In FIG. 2, FIG. 2 (A) shows an ampoule 12 filled with an ED therapeutic agent 10, and FIG. 2 (B) resets the injector 13 and the spring (not shown) of the injector 13 to a compressed state. A reset box 14 is shown, and FIG. 2C shows a state in which the ampoule 12 is attached to the injector 13.
The ampoule 12, the injector 13, and the reset box 14 are known.

In FIG. 2A, the ampoule 12 is filled with the ED therapeutic agent 10, and the ED therapeutic agent 10 is produced by mixing the supernatant 3 after culturing stem cells with the prostaglandin preparation or the PDE5 inhibitor 4. Has been done.
The work of filling the ampoule 12 with the ED therapeutic agent 10 is performed via an adapter (not shown). At the time of filling, the plunger rod 12B is adjusted to fill a predetermined amount while visually recognizing the filling amount to the ampoule 12 by the measuring scale 12A.
The ampoule tip 12C on the opposite side of the plunger rod 12B and having a minute hole is pressed around the male genitalia, particularly against the side of the penis of the male genitalia, and the ED therapeutic agent 10 is administered. Reference numeral 12D in FIG. 2A is a screw for attaching to the injector 13 shown in FIG. 2C.

In FIG. 2B, when resetting the spring (not shown) of the injector 13 to the compressed state, the upper lid 14A of the reset box 14 is opened and the injector 13 is set inside (arrow A). Then, the upper lid 14A is closed, and the injector 13 is mounted in the reset box 14.
Although not clearly shown, the above-mentioned operation causes a compression mechanism (not shown) in the reset box 14 to act on a spring (not shown) in the injector 13 to compress the spring. Then, in the injector 13, the accumulation of the injection pressure of the ED treatment drug 10 is completed.
When the accumulation of the injection pressure of the ED therapeutic agent 10 is completed, the upper lid 14A of the reset box 14 is opened and the injector 13 is removed from the reset box 14 (arrow B).

In FIG. 2C showing a state in which the ampoule 12 filled with the ED therapeutic agent 10 is attached to the injector 13 accumulating the injection pressure of the ED therapeutic agent 10, the attachment portion 13A (opening side) of the injector 13 is attached. The plunger rod 12B of the ampoule 12 is inserted. The mounting screw 12D of the ampoule 12 is screwed with a female screw (not shown) inside the opening of the mounting portion 13A of the injector 13.
When administering the drug 10 for treating ED, the ampoule 12 is attached to the injector 13, and then the ampoule tip 12C is pressed perpendicularly to the side of the penis of the male genitalia. Then, the safety mechanism 13B is slid to the ampoule 12 side (arrow C: left side in FIG. 2C) to release the engagement with the lever 13C. As a result, the safety mechanism 13B of the injector 13 is released. If the injection lever 13C is pressed in this state, the ED therapeutic agent 10 is administered to the side of the penis of the male genitalia. Details of administration will be described with reference to FIG.

Produced by mixing the ED therapeutic agent 10 composed of the supernatant 3 obtained from the liquid medium obtained by culturing and collecting the stem cells (1), or the supernatant 3 and the prostaglandin preparation or the PDE5 inhibitor 4. In FIG. 3, which shows a state in which the ED therapeutic agent 10 is administered, the ED therapeutic instrument 11 is configured by attaching the ampoule 12 to the injector 13.
In FIG. 3, the tip 12C of the ampoule 12 is pressed perpendicularly to the patient's male genitalia 20. When the injection lever 13C of the injector 13 is pressed in the state shown in FIG. 3, a compressed spring (not shown) in the injector 13 expands and pushes out the plunger rod 12B (FIG. 2) of the ampoule 12 to fill the ampoule 12. The ED therapeutic agent 10 is instantaneously ejected from the ampoule tip 12C.
As shown by the arrow J, the injected ED therapeutic agent 10 penetrates the white film 22 covering the corpus cavernosum 21 of the male genitalia 20 and reaches the corpus cavernosum 21.

[Example 1]
Cultivate adipose-derived mesenchymal stem cells, umbilical cord and umbilical cord blood-derived mesenchymal stem cells, dental pulp-derived mesenchymal stem cells, or bone marrow-derived mesenchymal stem cells using a liquid medium, and collect the cultured stem cells. The liquid medium (2) after the treatment was passed through a filter to remove impurities such as cells and allowed to stand, and the supernatant 3 obtained separately from the precipitate was used as the ED therapeutic agent 10 according to the embodiment of the present invention. And said. Then, the ampoule 12 was filled with the supernatant 3 as the ED therapeutic agent 10.

[Example 2]
A prostaglandin E1 preparation was selected as the prostaglandin preparation or the PDE5 inhibitor 4, and the supernatant 3 and the prostaglandin E1 preparation were mixed to produce the ED therapeutic agent 10 according to the embodiment of the present invention.
In an experiment conducted by the inventor, when a prostaglandin preparation or a prostaglandin E1 preparation is selected as a PDE5 inhibitor 4, and the supernatant 3 and the prostaglandin E1 preparation are mixed to produce an ED therapeutic drug 10. Has been confirmed to be effective against ED when 20 μg of a prostaglandin E1 preparation is dissolved in 1 ml of the culture supernatant, regardless of the mixing ratio.
Then, the ampoule 12 was filled with the drug 10 for treating ED.

[Experimental Example 1]
After culturing the adipose-derived mesenchymal stem cells 1 of each of the three ED patients who volunteered for the experiment in a commercially available liquid medium 2 (for example, a serum-free medium manufactured and sold by the applicant). After collecting the cultured stem cells 1, the supernatant 3 was collected by separating from the precipitate.
This supernatant 3 was filled in ampoules 12 as an ED therapeutic agent 10 and administered to the side of the penis of the male genitalia 20.
Self-reported by 3 patients improved erection and had a significant effect.

[Experimental Example 2]
A prostaglandin E1 preparation is selected as the prostaglandin preparation or the PDE5 inhibitor 4, and the supernatant and the prostaglandin E1 preparation are dissolved in 1 ml of the supernatant 3 (the supernatant obtained in Experimental Example 1). Ampoule 12 was filled with 0.5 ml and administered to the side of the penis of the male organ 20.
Self-reporting by 4 patients improved erection and had a significant effect.

[Experimental Example 3]
Using the supernatant 3 after culturing one stem cell 1 of the three patients in Experimental Example 1, one patient (applicant) different from the patient in Experimental Example 1 (patient in which stem cells were cultured) We conducted an experiment on. The obtained supernatant 3 was filled in the ampoule 12 in the same manner as in Experimental Example 1 and administered to the side of the penis of the male genitalia 20.
No rejection was confirmed after administration. According to the self-report of the treated patients, the erection was improved and there was a significant effect.
From Experimental Example 3, the supernatant 3 after culturing the stem cells 1 is not limited to the supernatant 3 after culturing the stem cells of the ED patient who is administered the ED therapeutic agent according to the experimental example, and in the ED patient. It was found that even the supernatant 3 after culturing the stem cells 1 of another person can be used.

[Experimental Example 4]
Similar to Experimental Example 3, the supernatant 3 after culturing one stem cell 1 was used for an experiment on one patient (applicant) different from the patient in Experimental Example 2 (patient in which stem cells were cultured). Was done.
A prostaglandin preparation or a prostaglandin E1 preparation was selected as the PDE5 inhibitor 4, dissolved in 1 ml of the supernatant 3, 0.5 ml was filled in the ampoule 12, and administered to the side of the penis of the male genitalia 20. ..
No rejection was confirmed after administration. According to the self-report of the treated patients, the erection was improved and there was a significant effect.
From Experimental Example 4, even when the prostaglandin E1 preparation is mixed with the supernatant 3 after culturing the stem cell 1, the supernatant 3 obtained after culturing the stem cell 1 of another person who is not an ED patient can be used. It turned out to be possible.

In other experiments by the inventor, even if the adipose-derived mesenchymal stem cells are not the supernatant after culturing, the dentin-derived mesenchymal stem cells are cultivated and the bone marrow-derived mesenchymal stem cells are cultivated. It has been confirmed by other experiments by the inventor that even the supernatant after culturing the mesenchymal stem cells derived from the supernatant, umbilical cord and umbilical cord blood is effective against ED.
Further, in Experimental Example 1 and Experimental Example 2, another experiment by the inventor that other prostaglandin preparations and PDE5 inhibitors are effective against ED instead of the prostaglandin E1 preparation. It was confirmed in.

[Experimental Example 5]
A mixture of 20 μg of prostaglandin E1 preparation dissolved in 1 ml of physiological saline was administered to three ED patients who volunteered for the experiment by using a needleless syringe. The supernatant was not mixed with the administered mixture.
Two did not erection and one did. In other words, in Experimental Example 3, as a result of administration without mixing the supernatant, the effect of administration of the prostaglandin E1 preparation was not exhibited in 2/3 of the subjects. It is very probable that the effect of administration of the prostaglandin E1 preparation did not appear in 2/3 of the subjects, and it is estimated that the prostaglandin E1 preparation did not reach the corpus cavernosum in Experimental Example 3. To.
From Experimental Example 3, it was confirmed that the possibility of improving ED is low when the supernatant 3 is not mixed.
From the above experimental examples, it is considered that the presence of the supernatant promotes the permeation of the white membrane of a drug such as prostaglandin.

Although not described as an experimental example, in an experiment conducted by the inventor, the supernatant of a liquid medium in which the patient's own fat-derived stem cells were cultured was administered to an ED patient who volunteered for the experiment by using an acardiac syringe. As a result, although it was self-reported by the patient, the ED of about 70% of the patients was improved. From this, it was confirmed that even when the supernatant alone was administered, it was effective in treating ED.
Also, in another experiment by the inventor, the ED of about 60% of patients was improved even when the supernatant was administered by electroporation.
Furthermore, another experiment by the inventor confirmed that the therapeutic effect was significantly improved when used in combination with extracorporeal shock wave therapy. In addition, when extracorporeal shock wave therapy was performed after direct supernatant administration (introduction) to the corpus cavernosum with a needle syringe, inflammation may occur in the white membrane at the introduction site, but in the case of a needleless syringe, inflammation Did not cause.

As shown in the experimental example, it was confirmed that the ED therapeutic agent 10 according to the illustrated embodiment has a significant effect on the treatment of ED patients.
Since the drug 10 for treating ED according to the embodiment is prepared by mixing a prostaglandin preparation or a PDE5 inhibitor 4 and a supernatant 3 after culturing stem cells, the white film covering the corpus cavernosum 21 of the male genitalia 20 is produced. It is presumed that it easily permeates 22 and that the prostaglandin preparation or PDE5 inhibitor 4 surely reaches the corpus cavernosum 21 when administered to the male genitalia 20.
Then, in the ED treatment instrument 11 according to the embodiment, the ampoule 12 is filled with the ED treatment agent 10 according to the embodiment. Therefore, when the ED therapeutic agent 10 is administered to the male genitalia 20 of the patient using the ED therapeutic instrument 11, it can be administered without causing severe pain to the patient.

Here, the supernatant 3 mixed with the ED therapeutic agent 10 is not only the supernatant 3 obtained by culturing the stem cells 1 of the patient to whom the ED therapeutic agent 10 is administered, but also the stem cells 1 of another person other than the patient. As described in Experimental Example 2, it has been clarified that the cultured supernatant 3 may be used. In other words, even in the supernatant 3 obtained by culturing stem cells 1 other than the patient to which the ED therapeutic agent 10 is administered, the effect of the ED treatment is recognized and no rejection reaction occurs.

In addition, since the supernatant increases the permeability, the drug may infiltrate the organs around the side of the penis to be administered. For example, if the supernatant component may infiltrate the prostate gland or seminal vesicles, and if the supernatant solution causes some kind of infection, the infection propagates to those organs, causing inflammation of the penis, exacerbation of ED, and so on. Causes pain, infertility and malformations. Therefore, it is convenient that the supernatant used in the present invention is produced in a medium (completely serum-free medium, AOF medium) completely free of animal component-derived components, at least during subculture, preferably during primary culture. Is good.

Not only organic but also psychogenic ED is well known, and psychological conflict and stress can cause erectile dysfunction. The detailed mechanism by which psychological factors cause erectile dysfunction is unknown, but it is known that psychotherapy, image therapy, and DTx (digital therapies) using these are effective for psychogenic ED. ing. The inventors have found that the combined use of these therapies and the therapy of the supernatant of the present invention effectively improves erectile dysfunction due to functional recovery of the corpus cavernosum.

It should be added that the illustrated embodiment is merely an example and is not a description intended to limit the technical scope of the present invention.
For example, although not shown, the present invention also applies to the use of a conventional syringe with a needle. In that case, it has been confirmed by the inventor's experiment that the effect of ED treatment is recognized and no rejection reaction occurs.

1 ... Stem cell 2 ... Medium 3 ... Supernatant 4 ... Prostaglandin preparation or PDE5 inhibitor 10 ... ED therapeutic agent 11 ... ED therapeutic instrument 12 ... Ampoule 21・ ・ ・ Cavernosum

Claims (11)

A drug for treating erectile dysfunction, which comprises a supernatant obtained from a liquid medium after culturing and collecting stem cells. The agent for treating erectile dysfunction according to claim 1, which is administered to the male genitalia or around the male genitalia. The agent for treating erectile dysfunction according to claim 1 or 2, wherein the supernatant obtained from the liquid medium obtained by culturing and collecting stem cells is mixed with a prostaglandin preparation or a PDE5 inhibitor. The drug for treating erectile dysfunction according to any one of claims 1 to 3, which is used in the treatment of supplying a drug into the body of a patient without using a needle syringe. The agent for treating erectile dysfunction according to any one of claims 1 to 4, which is used in combination with extracorporeal shock wave therapy. The agent for treating erectile dysfunction according to any one of claims 2 to 5, which is used in combination with psychotherapy or image therapy, or digital therapy using them. Stem cells are cultured in a liquid medium, and after the cultured stem cells are collected, the liquid medium is passed through a filter to remove impurities such as cells. After removing the contaminants, the cells are allowed to stand to separate from the precipitate and the supernatant. A method for producing a drug for treating erectile dysfunction, which comprises a step of obtaining. The method for producing a drug for treating erectile dysfunction according to claim 7, which comprises a step of mixing the supernatant with a prostaglandin preparation or a PDE5 inhibitor. An device for treating erectile dysfunction, which comprises an ampoule filled with a drug for treating erectile dysfunction, which contains a supernatant obtained from a liquid medium after culturing and collecting stem cells. The device for treating erectile dysfunction according to claim 9, wherein the ampoule is filled with a drug for treating erectile dysfunction, which is a mixture of the supernatant and a prostaglandin preparation or a PDE5 inhibitor. The agent for treating erectile dysfunction, the method for producing an erectile dysfunction therapeutic agent, or an instrument for treating erectile dysfunction according to any one of claims 1 to 10, wherein the supernatant is produced in a serum-free medium.

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