Pre-clinical Endometrial Tissular Renovation Study

Plain-language summary

The endometrium is a tissue with high capacity of renewal ("self-renewal"). This process is regulated by stem cells. Recent studies have shown that bone marrow-derived stem cells (BMDSCs) contribute to tissues and organs regeneration, including the murine and human endometrium. Additionally, BMDSCs have the ability to differentiate into functional endometrial and stromal epithelial cells. Asherman's Syndrome (AS) also referred to as intrauterine adhesions (AIU), is an acquired uterine condition characterized by the formation of adhesions inside the uterus. In many cases the front and back walls of the uterus stick to one another. Most patients with AS have menstrual abnormalities, pelvic pain, recurrent miscarriage, and infertility, and psychological disorders. Currently, hysteroscopy is considered the gold standard of methods for the diagnosis of intrauterine adhesions. However, it has a limited capacity for treatment, especially in moderate or severe cases in which permanent infertility can occur. For the first time, our investigation group demonstrated the possibility of regenerating endometrial tissue through bone marrow-derived stem cells (Santamaria et al., 2016). This project aims to determine the safety, tolerability and biodistribution of IGX1 (CD133+ cells selected after mobilization and collection of peripheral blood progenitor cells - CPSP) afte rthe intraarterial injection in rats with induced Asherman's Syndrome. Therefore, the focus of this project is to satisfy the preclinical requirements set out by the the AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) in relation to the Phase I/II clinical trial "Phase I-II clinical trial of advanced, prospective, open, non-randomized, uncontrolled (before-after study), explanatory, multicentre cell therapy , national, intervention with a single treatment group in patients of reproductive age with gestational desire diagnosed with Asherman's Syndrome grade II, III or IV, treated by autologous non-expanded bone marrow stem/progenitor cells selected (IGX1)" (IGX1-ENT-XS-16-01)

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