ArticleEClinicalMedicine2024
Safety and efficacy of allogenic human amniotic epithelial cells transplantation via ovarian artery in patients with premature ovarian failure: a single-arm, phase 1 clinical trial.
Article in EClinicalMedicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Cellular therapies in primary ovarian insufficiency and poor ovarian reserve: a systematic review.Journal of assisted reproduction and genetics · 2025Pooled it
- Evaluation of intraovarian injection of platelet-rich plasma for enhanced ovarian function and reproductive success in women with POI and POR: a systematic review and meta-analysis.European journal of medical research · 2025Pooled it
- Current Status of Animal Models for Premature Ovarian Insufficiency: Similarities to Clinical Manifestations and Therapeutic Applications.Tissue engineering and regenerative medicine · 2026Review
- The Fibro-Inflammatory Ovary: Stromal Fibrosis, Extracellular Matrix Remodeling, and Mechanotransduction in Female Infertility.Current issues in molecular biology · 2026Review
- HucMSC-mediated stromal metabolic reprogramming in reactivating aged ovaries: a single-cell transcriptomic perspective.Cellular & molecular biology letters · 2026Article
- hAECs restore follicular development in premature ovarian insufficiency via IGFBP2/IGF1R-mediated intercellular communication.Stem cell research & therapy · 2026Article
- Therapeutic effects of mesenchymal stem cell-derived extracellular vesicles from different tissue sources on diminished ovarian reserve and the related mechanisms.Journal of nanobiotechnology · 2026Article
- Insulin-like growth factor 1 as a key paracrine mediator in mesenchymal stem cell-based intervention for ovarian ageing: a review.Journal of ovarian research · 2026Review
- Therapeutic potential of stem cells in addressing female infertility: recent progress and prospective developments.Frontiers in medicine · 2026Review
- Comparative evaluation of the therapeutic efficacy between human amniotic epithelial cells and human umbilical cord mesenchymal stem cells in premature ovarian insufficiency.Stem cell research & therapy · 2025Article
- [Stem cell therapy for premature ovarian insufficiency: a review of clinical evidence and therapeutic strategies].Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2025Review
- Review
- Mesenchymal stem cells: opening a new chapter in the treatment of gynecological diseases.Stem cell research & therapy · 2025Review
- Precision medicine in premature ovarian insufficiency: a focus on the precision therapeutic strategies for mesenchymal stem cells.Stem cell research & therapy · 2025Review
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Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Premature ovarian failure (POF) is a prevalent and severe condition that impairs female health but there is currently no effective treatment available to restore ovarian function. Human amniotic epithelial cells (hAECs) exhibit ovarian protection in pre-clinical models. Thus, we conducted a single-arm, phase 1 clinical trial to assess the safety and efficacy of allogenic hAECs in treating POF. Methods: A total of 35 patients received 6 × 10 Findings: No serious AEs were observed throughout the five-month follow-up period. The most common AE was hematoma (7/35, 20.00%), and other AEs include pelvic pain (4/35, 11.43%), fever (2/35, 5.71%), anaphylaxis (2/35, 5.71%), and hepatotoxicity (1/35, 2.86%). After hAECs transplantation (hAECT), significant improvements were observed in the levels of endometrial thickness, left ovarian volume, sex hormones (follicle-stimulating hormone (FSH) and estradiol (E2)), and MENQOL scores in all patients during the five-month follow-up period. Among them, 13 participants (37.14%) experienced spontaneous menstrual bleeding, and 20.00% (7/35) reported more than one regular menstrual bleeding post-hAECT. In this response group, significant improvements were observed in endometrial thickness, left ovarian volume, levels of FSH, E2, anti-Müllerian hormone (AMH), and MENQOL scores one month after hAECT in comparison to pre-hAECT. Interpretation: hAECT via ovarian artery is safe, well-tolerated and temporarily ameliorates endometrial thickness, ovarian size, hormone levels, and menopausal symptoms in POF patients. Further randomized controlled trial of hAECs with longer follow-up period and a larger sample size is warranted. Funding: National Natural Science Foundation of China (No. 82271664), the Interdisciplinary Program of Shanghai Jiao Tong University (YG2022ZD028), the Shanghai Municipal Health Committee (202240345), Shanghai Key Laboratory of Embryo Original Diseases (No. Shelab2022ZD01), Shanghai Municipal Education Commission (No. 20152236), and National Key Research and Development Program of China (No. 2018YFC1004802), Shanghai Clinical Research Center for Cell Therapy, China (No. 23J41900100).
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