Assessment of long-term function of heterotopic transplants of vitrified ovarian tissue in cynomolgus monkeys

Suzuki, Nao; Hashimoto, Shu; Igarashi, Suguru; Takae, Seido; Yamanaka, M.; Yamochi, Takayuki; Takenoshita, Makoto; Hosoi, Yoshihiko; Morimoto, Yoshiharu; Ishizuka, Bunpei

doi:10.1093/humrep/des178

Cited by 58 publications

(38 citation statements)

References 38 publications

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“…THT, comprising treatment with female hormones secreted by the patient's own transplanted ovaries for purposes other than of becoming pregnant, is a promising new method of treatment 17) . Whether the transplantation of cryopreserved ovarian tissue has a cosmetic effect on skin equivalent to that of HRT was investigated using the ovarian tissue cryopreservation techniques developed via continuing basic studies in Macaca fascicularis and rats [18][19][20] . Studies have shown that visceral fat increases after oophorectomy due to the lack of female hormones 21) , and in the present study, the amount of estrogen secreted by transplanted ovarian tissue was insufficient to improve the loss of skin elasticity induced by oophorectomy.…”

Section: Discussionmentioning

confidence: 99%

Anti-aging Effect on Skin of Autologous Transplantation of Tissue Fragments from Thawed Cryopreserved Ovaries

Imanishi

Igarashi

Yamaguchi³

et al. 2017

J St. Marianna Univ

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Transplanting the ovaries of young mice into menopausal mice has been shown to extend their lifespan, suggesting that the reproductive organs may play an important role in combating aging. Preventing skin aging is an extremely important matter with respect to maintaining quality of life, but little basic research has been carried out on this issue. The effects of treatment with cryopreserved ovarian tissue, tissue hormone therapy (THT), and hormone replacement therapy on inhibiting skin aging in experimental animals were investigated. The effects on skin elasticity and body weight changes in 6-week-old mice resulting from the transplantation of cryopreserved ovarian tissue were evaluated, as were the effects on skin of estrogen administration after bilateral oophorectomy or transplantation. Estrogen was secreted by mouse ovaries that had been frozen, thawed, and transplanted, and the estrus cycle was restored, but this was insufficient to have any effect on skin elasticity. After oophorectomy, the body weight of the mice increased, and their skin elasticity decreased. Estrogen administration after these changes had occurred neither restored skin elasticity nor suppressed body weight gain. However, when estrogen was continuously administered from immediately after oophorectomy, skin elasticity decreased transiently and then improved. If techniques for THT using cryopreserved ovaries to maintain the blood estrogen concentration above a specific level can be established, this might help to prevent or improve the deterioration of skin appearance in young women who require oophorectomy due to gynecological disease and also in childhood, adolescent, and young adult cancer patients.

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Section: Discussionmentioning

confidence: 99%

Anti-aging Effect on Skin of Autologous Transplantation of Tissue Fragments from Thawed Cryopreserved Ovaries

Imanishi

Igarashi

Yamaguchi³

et al. 2017

J St. Marianna Univ

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“…Chen et al 32 developed a modified vitrification method for murine ovarian grafts and successfully produced impregnated mice that delivered newborns. Suzuki et al 33 studied vitrified ovarian grafts in monkeys (a primate model), but there were no pregnancies. Further research into the cryopreservation of the entire ovary is required in both humans and animal models.…”

Section: Discussionmentioning

confidence: 99%

Antiapoptotic Agent Sphingosine-1-Phosphate Protects Vitrified Murine Ovarian Grafts

et al. 2014

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Significant follicle loss from frozen ovarian grafts is unavoidable. The authors evaluated the protective effects of the antiapoptotic agent sphingosine-1-phosphate (S1P) on vitrified ovarian grafts. Three-week-old sexually immature female FVB mice were divided into 4 groups, fresh, control without S1P, 0.5 mmol/L S1P, and 2 mmol/L S1P. The ovaries were pretreated with S1P for 1 hour and then cryopreserved by modified vitrification. The frozen-thawed ovaries were autotransplanted under the back muscles of mice for 10 days. Expression of apoptosis-related genes encoding caspase 3 and c-Myc was analyzed in the vitrified ovaries and 10 days after transplantation using real-time quantitative polymerase chain reaction. To quantify the ovarian reserve, anti-Müllerian hormone (AMH) levels and follicles were measured in the 10-day vitrified ovarian grafts. Caspase 3 and c-Myc messenger RNA did not differ significantly in the 4 groups after vitrification but was significantly upregulated in the control group after transplantation. The AMH levels and primordial follicle pool were significantly higher in the S1P-treated groups than in the control group but lower than that in the fresh group. The S1P protects vitrified ovarian grafts from ischemic reperfusion injury rather than from vitrification-associated process.

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“…[16] Xenograft and recovery of primordial or secondary follicle-containing bovine tissue into mice [17] X X PrOH, PVP Histology and ultrastructure in human [11,12] X X PVP Histology, follicle count, and ultrastructure in cynomolgus macaques [18] Autotransplant, histology and ultrastructure, vascularization of graft, serum E2 and P4, ova stimulation, and embryo development through ICSI in cynomolgus macaques [19] Autotransplant, serum E2 and P4, ova stimulation, and embryo development through ICSI, 2 successful deliveries in human [20] X X X PVP K-10 Apoptosis, proliferation, and fibrosis of human xenografted in mice [21] Autotransplant, histology, follicle count, proliferation, apoptosis, graft vascularization and fibrosis, AMH immunohistochemistry in Papio anubis [22] Autotransplant, histology, follicle count, proliferation, apoptosis, graft vascularization and fibrosis, AMH immunohistochemistry in cynomolgus macaques…”

Section: Kit Componentsmentioning

confidence: 99%

Good manufacturing practice requirements for the production of tissue vitrification and warming and recovery kits for clinical research

Laronda

McKinnon

Ting

et al. 2016

J Assist Reprod Genet

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Products that are manufactured for use in a clinical trial, with the intent of gaining US Food and Drug Administration (FDA) approval for clinical use, must be produced under an FDA approved investigational new drug (IND) application. We describe work done toward generating reliable methodology and materials for preserving ovarian cortical tissue through a vitrification kit and reviving this tissue through a warming and recovery kit. We have described the critical steps, procedures, and environments for manufacturing products with the intent of submitting an IND. The main objective was to establish an easy-to-use kit that would ensure standardized procedures for quality tissue preservation and recovery across the 117 Oncofertility Consortium sites around the globe. These kits were developed by breaking down the components and steps of a research protocol and recombining them in a way that considers component stability and use in a clinical setting. The kits were manufactured utilizing current good manufacturing practice (cGMP) requirements and environment, along with current good laboratory practices (cGLP) techniques. Components of the kit were tested for sterility and endotoxicity, and morphological endpoint release criteria were established. We worked with the intended down-stream users of these kits for development of the kit instructions. Our intention is to test these initial kits, developed and manufactured here, for submission of an IND and to begin clinical testing for preserving the ovarian tissue that may be used for future restoration of fertility and/or hormone function in women who have gonadal dysgenesis from gonadotoxic treatment regimens or disease.Keywords Good manufacturing practice . Vitrification . Ovary . Oncofertility Purpose Current Good Manufacturing Practice (cGMP) regulations are enforced by the US Food and Drug Administration in order to ensure the quality of manufactured drug products. These guidelines are listed in the 21 Code of Federal Regulations (CFR) part 211 [1]. cGMPs include a set of guidelines for facility standards, proper documentation, and implementation of procedures. Additionally, equipment within facilities used for drug manufacturing must be monitored and calibrated under cGMP guidelines and personnel must be properly trained and proficient in the facility procedures in order to be compliant. Current good laboratory practices (cGLPs) are additional guidelines that ensure that the data generated by testing the Capsule The main objective of this study was to establish an easy-to-use kit for standardized ovarian tissue vitrification and recovery. We have described the critical steps, procedures, and environments for manufacturing media kits intended for an Investigational New Drug (IND) application for future clinical trials.Electronic supplementary material The online version of this article

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Assessment of long-term function of heterotopic transplants of vitrified ovarian tissue in cynomolgus monkeys

Cited by 58 publications

References 38 publications

Anti-aging Effect on Skin of Autologous Transplantation of Tissue Fragments from Thawed Cryopreserved Ovaries

Anti-aging Effect on Skin of Autologous Transplantation of Tissue Fragments from Thawed Cryopreserved Ovaries

Antiapoptotic Agent Sphingosine-1-Phosphate Protects Vitrified Murine Ovarian Grafts

Good manufacturing practice requirements for the production of tissue vitrification and warming and recovery kits for clinical research

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