Clinical Trial for PCOS (Polycystic Ovary Syndrome)

Sindrom ovarium polikistik (SOPK) is a group of signs and symptoms that occur in women of reproductive age, which include disturbances in the menstrual cycle or anovulatory cycles. Generally, PCOS is characterized by hormonal imbalances and elevated levels of androgens, which can lead to symptoms such as excessive hair growth (hirsutism), acne, and difficulties in getting pregnant. Additionally, other symptoms may include weight gain, anxiety, and depression. The anxiety and depression associated with PCOS can have negative impacts on health and mental well-being (Tabassum, 2021).

The prevalence of PCOS varies depending on the diagnostic criteria used. In the United States, about 5 million young women are diagnosed with PCOS, while in India, approximately 9.13% of teenagers experience this condition. In Southeast Asia, the prevalence of PCOS is quite high, reaching 52% in women (Rajuddin, 2021). Women with PCOS have a higher risk of developing type 2 diabetes mellitus, with around 39.3% experiencing this condition within 10 years. Unhealthy lifestyle factors play a significant role in the occurrence of PCOS. Obesity and insulin resistance are often associated with this condition. A meta-analysis found that about 27% of PCOS cases have insulin resistance, and an increased Body Mass Index (BMI) can raise this risk by up to 15% (Neven, 2018). The prevalence of insulin resistance varies depending on factors such as age, BMI, and race. Additionally, an unhealthy diet and lack of physical activity also contribute to central obesity and menstrual disorders. Unhealthy lifestyles can trigger epigenetic changes in the body, involving alterations in biomolecular metabolism processes. This is caused by the dysregulation of proinflammatory cytokines, which can affect women's reproductive organs and lead to PCOS (Amirjani, 2019).

The importance of using mesenchymal stem cells (MSC) or mesenchymal stem cell/conditioned medium (MSC/CM) in treating polycystic ovary syndrome (PCOS) with insulin resistance is known due to their sustained effects. Based on several studies, it has been revealed that MSCs and MSC secretomes have the ability to modify the regulation profile of inflammation, proliferation, or apoptosis of cells. This results in longer-lasting treatment effects, so patients do not need to constantly consume medication (Xie et al., 2019).

The research has found that UCMSCs transplantation can restore ovarian function in rats induced with PCOS by dehydroepiandrosterone (DHEA). This effect is conveyed through a decrease in the expression of inflammatory cytokines, including interleukin 1 beta (IL-1𝛽), tumor necrosis factor alpha (TNF-𝛼), and interferon gamma (IFN-𝛾), as well as genes associated with fibrosis such as connective tissue growth factor (CTGF). The results of this study indicate that UCMSCs transplantation can help alleviate ovarian disorders in PCOS (Esfandyari, 2020).

ProSTEM conducted clinical trials in collaboration with Colonel Dr. Gunawan Dwi Prayitno, SpOG, Subsp.F.E.R to explore the potential of stem cells for treating Polycystic Ovary SyndromeIf you are willing to participate in this research, please contact CP 089664446886 (Erin).

Refrences :

1 C. H. Neven, J. Laven, H. J. Teede, and J. A. Boyle, “A summary on polycystic ovary syndrome: Diagnostic criteria, prevalence, clinical manifestations, and management according to the latest international guidelines,” Semin. Reprod. Med., vol. 36, no. 1, pp. 5–12, 2018, doi: 10.1055/s-0038-1668085.

2 Xie et al., “Mesenchymal Stem Cells Alleviate DHEA-Induced Polycystic Ovary Syndrome (PCOS) by Inhibiting Inflammation in Mice,” Stem Cells Int., vol. 2019, 2019, doi: 10.1155/2019/9782373.

3 L. Rajuddin, “Association between homeostatic model assessment for insulin resistance (HOMA-IR) and obesity in infertile female due to polycystic ovary syndrome,” Assoc. between Homeost. Model Assess. Insul. Resist. Obes. infertile female due to polycystic ovary Syndr., vol. 1(1), pp. 16–20, 2021.

4 Amirjani et al., “Dietary intake and lifestyle behaviour in different phenotypes of polycystic ovarian syndrome: a case–control study,” J. Hum. Nutr. Diet., vol. 32, no. 4, pp. 413–421, 2019, doi: 10.1111/jhn.12646.

5 Esfandyari, R. M. Chugh, H. S. Park, E. Hobeika, M. Ulin, and A. Al-Hendy, “Mesenchymal Stem Cells as a Bio Organ for Treatment of Female Infertility,” Cells, vol. 9, no. 10, pp. 1–19, 2020, doi: 10.3390/cells9102253.

6 Tabassum, C. Jyoti, H. H. Sinha, K. Dhar, and M. S. Akhtar, “Impact of polycystic ovary syndrome on quality of life of women in correlation to age, basal metabolic index, education and marriage,” PLoS One, vol. 16, no. 3, pp. 1–13, 2021, doi: 10.1371/journal.pone.0247486.

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