阅读说明：本技术 人羊膜上皮细胞在制备预防或治疗老年衰弱症药物中的用途 (Application of human amniotic epithelial cells in preparation of medicine for preventing or treating senile asthenia ) 是由 姬广超 王晓明 刘倩 于 2020-08-31 设计创作，主要内容包括：本发明公开了人羊膜上皮细胞在制备预防或治疗老年衰弱症药物中的用途,属于生物技术领域。老年衰弱症包括老年衰弱症或老年衰弱症前期,使用有效剂量的人羊膜上皮细胞或其细胞制剂单独或者与其他药物联合使用进行预防或治疗老年衰弱症,人羊膜上皮细胞为未经任何处理收集的细胞、部分纯化的细胞或者纯化后经人工培养增殖的细胞,单次有效剂量为1×10<Sup>6</Sup>-1×10<Sup>10</Sup>个细胞。本发明使用的人羊膜上皮细胞分离方法简便、无伦理学问题和无致瘤性,且具有多向分化和免疫调节能力,用于预防和治疗老年衰弱症具有较好的安全性和有效性,改善老年衰弱症人群的生活状态的同时,提高老年衰弱症人群的生活质量。(The invention discloses an application of human amniotic epithelial cells in preparation of a medicine for preventing or treating senile asthenia, and belongs to the technical field of biology. The senile asthenia disease comprises senile asthenia disease or early stage senile asthenia disease, and can be used for preventing or treating senile asthenia disease by using effective dose of human amniotic epithelial cells or cell preparation thereof alone or in combination with other medicines, wherein the human amniotic epithelial cells are cells collected without any treatment, partially purified cells or cells artificially cultured and proliferated after purification, and the single effective dose is 1 × 10 6 ‑1×10 10 And (4) cells. The method for separating the human amniotic epithelial cells used by the invention is simple and convenient, has no ethical problems and no tumorigenicity, andhas multidirectional differentiation and immunoregulation capabilities, has good safety and effectiveness when being used for preventing and treating senile asthenia, and improves the life state of senile asthenia people and the life quality of senile asthenia people.)

1. The application of the human amniotic epithelial cells or the cell preparations thereof in preparing the medicines for preventing or treating the senile asthenia.

2. The use according to claim 1, wherein the senile frailty comprises senile frailty or pre-senile frailty.

3. The use according to claim 1 or 2, wherein the senile frailty is prevented or treated with an effective amount of human amniotic epithelial cells or cell preparations thereof alone or in combination with other drugs.

4. The use of claim 3, wherein the single effective dose of human amniotic epithelial cells is 1 x 10⁶-1×10¹⁰And (4) cells.

5. The use according to claim 1, wherein the human amniotic epithelial cells are suitably harvested cells without any treatment, partially purified cells or cells which have been artificially cultured and propagated after purification.

6. The use according to claim 5, wherein the human amniotic epithelial cells have a cell viability of 50% to 100% and can be used directly or by resuscitation after cryopreservation.

7. The use of claim 1, wherein the human amniotic epithelial cells are administered to the patient using any suitable method, including but not limited to intravenous injection.

8. A pharmaceutical composition for preventing or treating senile asthenia is characterized in that human amniotic epithelial cells are used as active ingredients, and the single effective dose is 1 x 10⁶-1×10¹⁰And (4) cells.

9. The pharmaceutical composition according to claim 8, wherein the human amniotic epithelial cells are collected without any treatment, partially purified cells or purified cells propagated by artificial culture.

10. The pharmaceutical composition of claim 8, further comprising an auxiliary liquid, and the auxiliary liquid includes, but is not limited to, human serum albumin and physiological saline.

Technical Field

The invention belongs to the technical field of biology, and particularly relates to application of human amniotic epithelial cells in preparation of a medicine for preventing or treating senile asthenia.

Background

It is generally considered that asthenia is a common senile syndrome, mainly manifested by increased vulnerability of the body, decreased ability to maintain homeostasis, increased risk of morbidity and mortality, etc., and its core feature is decreased reserve function of multiple physiological systems. The asthenia disease is not only body dysfunction, but also mental disorder, is related to disability and diseases (co) but not identical to disability and diseases, senile asthenia disease patients may not have disability or co-diseases, and only have fatigue, emaciation, depression and the like, and the disability rate and the fatality rate of the senile people are obviously higher than those of non-asthenia disease elderly.

Chronic inflammation and immune dysfunction play an important role in the pathogenesis of asthenia, the aging of the immune system is characterized by chronic low-level systemic inflammation, the inflammatory state related to aging is called inflammatory aging, the increase of inflammatory cytokines is taken as a mark, and the research finds that the increase of inflammatory cytokines interleukin-6 (IL-6), C-reactive protein (CRP) and Tumor Necrosis Factor (TNF) -alpha is related to the increase of morbidity and mortality of the elderly, and the increase of inflammatory reaction markers in the asthenia elderly is found. Based on the weakened immune theory, Walston et al suggested that IL-10 gene knockout homozygote (IL-10) by altering mouse genes to mimic the pathophysiological changes of human weakness^tm/tm) Can be used as a model of debilitation, IL-10^tm/tmMice do not produce the anti-inflammatory factor IL-10, resulting in elevated levels of inflammation in the body. In particular, IL-10^tm/tmThe mice have higher levels of inflammatory factors (IL-6, IL-1 beta, Tumor Necrosis Factor (TNF) -alpha and Interferon (IFN) -gamma) than normal wild-type mice, and earlier decline in muscle strength, cardiovascular dysfunction, vascular sclerosis, endothelial dysfunction, leading to increased all-cause mortality, all of which are similar to debilitating manifestations in humans, and exhibit multiple organ dysfunction.

The Human Amniotic Epithelial Cells (Human Amniotic Epithelial Cells) have the characteristics of expressing various embryonic stem cell markers, have the potential of differentiating to a three-germ layer, show unique immune-privileged and immune-regulatory functions and have potential application value in the aspect of treating immune-related diseases. Moreover, the separation method of the human amniotic epithelial cells is simple and convenient, has no ethical problem and tumorigenicity, has multidirectional differentiation and immunoregulation capability, can be widely applied to the fields of cell therapy, tissue regeneration and the like, and has no application report about the application of the human amniotic epithelial cells in preventing or treating senile asthenia at present.

Disclosure of Invention

The first purpose of the invention is to provide the application of the human amniotic epithelial cells in preparing the medicines for preventing or treating senile asthenia.

The second purpose of the invention is to provide a medicine composition for preventing or treating senile asthenia.

In order to achieve the first object, the invention adopts the technical scheme that:

the application of the human amniotic epithelial cells or the cell preparations thereof in preparing the medicines for preventing or treating the senile asthenia.

According to some embodiments of the use of the present invention, an effective amount of human amniotic epithelial cells or cell preparations thereof are used for preventing or treating senile asthenia, alone or in combination with other drugs.

Further, the single effective dose of the human amniotic epithelial cells is 1 multiplied by 10⁶-1×10¹⁰And (4) cells.

According to some embodiments of the use of the invention, the senile asthenia comprises senile asthenia or pre-senile asthenia.

According to some embodiments of the use of the present invention, the human amniotic epithelial cells are suitably collected cells without any treatment, partially purified cells or cells that have been artificially cultured and propagated after purification. It is to be noted that the human amniotic epithelial cells of the present invention are derived from a legal route and that the cell donors are free of infectious diseases and other conditions that may pose a risk to cell use.

Furthermore, the cell viability of the human amniotic epithelial cells is 50% -100%, and the human amniotic epithelial cells can be directly used or recovered after cryopreservation.

According to some embodiments of the uses of the present invention, the human amniotic epithelial cells may be administered to a patient using any suitable method, including but not limited to intravenous injection.

According to some embodiments of the use of the present invention, the method of preparing human amniotic epithelial cells comprises:

(1) direct isolation of human amniotic epithelial cells from human amniotic membrane, and/or

(2) Separating human amniotic epithelial cells by purification or culture treatment after cryopreservation of human amniotic membrane, and/or

(3) The human amniotic epithelial cells obtained by the two methods are artificially cultured and proliferated.

In order to achieve the second object, the invention adopts the technical scheme that:

a pharmaceutical composition for preventing or treating senile asthenia comprises human amniotic epithelial cells as active ingredient, and has a single effective dose of 1 × 10⁶-1×10¹⁰And (4) cells.

According to some embodiments of the pharmaceutical composition of the present invention, the human amniotic epithelial cells are suitably collected cells without any treatment, partially purified cells or cells that have been artificially cultured and proliferated after purification.

Further, auxiliary liquids including, but not limited to, human serum albumin and physiological saline are also included.

Compared with the prior art, the invention has the beneficial effects that: the method for separating the human amniotic epithelial cells is simple and convenient, has no ethical problem and tumorigenicity, has multidirectional differentiation and immunoregulation capabilities, has better safety and effectiveness when being used for preventing and treating the senile asthenia, and improves the life state of the senile asthenia people and the life quality of the senile asthenia people.

Drawings

Figure 1 is an amniotic membrane placed in a culture dish.

Detailed Description

Embodiments of the present invention will be described in detail below with reference to the drawings and examples, but those skilled in the art will understand that the following examples are only illustrative of the present invention and should not be construed as limiting the scope of the present invention. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products commercially available.

The human amniotic membrane is a transparent film for wrapping amniotic fluid and consists of an epithelial cell layer, a basement membrane and a non-vascular substrate, and a mature human amniotic membrane can reach 2 square meters in area, gathers about 3 hundred million amniotic cells and serves as a protective layer of an embryo, thereby not only providing nutrition for the development of the fetus, but also being a wonderful barrier for preventing two variant tissues of a mother body and the fetus from mutually rejecting. The human amniotic epithelial cells (HAEpiC) are extracted from human amniotic tissues, can express various embryonic stem cell markers, have the potential of differentiation to the three germ layers, also show unique immune-privileged and immune-regulatory functions, and have simple and convenient separation method, no ethical problems and no tumorigenicity.

The human amniotic epithelial cells used in the examples below were derived from a legal route and the cell donors were free of infectious disease and other conditions that may pose a risk to cell use.