Premature Ovarian Failure (POF) Clinical Trial
Official title:
Autologous Stem Cell Ovarian Transplantation to Restore Ovarian Function in Premature Ovarian Failure Patients. Pilot Study ASCOT-2
This study aims to recover ovarian function in POF/POI patients. With this pueprose we designed a study protocol including two arms: ASCOT arm, were patients receive the stem cell mobilization treatment with Granulocyte colony stimulating factor (G-CSF) followed by apheresis and ovarian artery catheterism to selectively infuse the stem cells into the ovary and the G-CSF arm including patients that receive the mobilization treatment but not the ovarian artery catheterism to selectively infuse the cells into the ovary.
Ovarian aging appears early in life as a decline in function at 30s leading to a complete
ovarian failure around 51 years of age in women. Women in modern society have delayed the age
of childbearing due to socioeconomic changes and patient´s age has become the main
determinant of infertility, since it is well known that both quantity and quality of the
oocytes from aging patients are seriously impaired. Nevertheless, the low ovarian reserve is
not only associated with age. Primary ovarian insufficiency (POI) is a cause of infertility
in women, affecting 1% of the population. It is characterized by amenorrhea, hypoestrogenism,
and elevated gonadotropin levels in women younger than 40 years of age. Impairment of ovarian
function in POI can be mixed up with a low ovarian reserve or poor ovarian response although
represent different clinical entities and patients.
Thus, interventions to recover damaged gonads in POI patients should be developed in order to
enhance their reproductive potential. Clinically, bone marrow (BM) transplant in patients
with POI due to chemotherapy treatment rescues ovarian functions as demonstrated by several
spontaneous pregnancies. Previous research demonstrates that autologous stem cell ovarian
transplantation (ASCOT) improves ovarian reserve (AMH and AFC) in 81% of women. Three of the
eleven included patients achieve 5 pregnancies and 3 healthy babies have born. Response is
highly variable between patients and molecular mechanisms still unknown. New approach is
mandatory to elucidate them.
Results obtained in our premature ovarian failure (POF) animal model (included chemotherapy,
CT ovarian injury) demonstrate that bone marrow stem cells restore ovulation by means of
increasing vascularization, proliferation and diminishing apoptosis within the ovarian niche.
These ovarian niche improvements promotes follicular development, increased number of antral
and preovulatory follicles and corpus luteum.
POF model is ideal to demonstrate effectivity of ASCOT technique as they represent the worst
possible scene. Any improvement in those patients should be significant.
Trying to be less invasive, we designed a study protocol including two arms: ASCOT arm as
previously described and Granulocyte colony stimulating factor (G-CSF) arm including patients
that receive the treatment but not the apheresis nor the ovarian artery catheterism to
selectively infuse the cells into the ovary.
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