Table 2.2.
Human studies involving bone marrow stem cell treatment for POI and perimenopausal patients.
| Regenerative factor | Study population | Administration method | Main findings | Limitations | Reference |
|---|---|---|---|---|---|
| BM-MSC | 1 perimenopausal woman (45-year old). AMH 0.4 ng/ml AFC = 1 |
BM-MSCs into both ovaries via laparoscopy. | -AFC and AMH increased 8 weeks after treatment. -1 live birth. |
POR similar to that reported for POI patients without treatment | Gupta et al. (17) |
| BM-MSC | 10 women with idiopathic POI (26–33 years old). AMH <0.1 ng/ml; FSH = 58 mIU/ml |
BM-MSCs into both ovaries via laparoscopy. | -Resumption of menses in 20% patients after 3 months. -10% treatment POR. -One pregnancy and a live birth in one patient showing endometrial regeneration. |
POR similar to that reported for POI patients without treatment | Edessy et al. (104) |
| BM-MSC | 30 patients with POF (18–40 years old). Baseline characteristics not reported. |
Direct laparoscopic infusion into the ovarian stroma and catheterism into the ovarian artery of one side. | -86.7% POF patients improved hormone profile 4 weeks after treatment. -60% showed ovulation. -3 patients underwent IVF. -1 spontaneous pregnancy. |
-AFC not reported or compared between ovaries. -IVF outcomes were not reported. |
Gabr et al. (105) |
| BM-MSC | 33 patients with idiopathic/other POF/POI and low ovarian reserves. Baseline characteristics not yet reported. |
BM-MSCs into both ovaries via laparoscopy. | Not yet reported | Still ongoing | Al-Hendy et al. (NCT02696889) |
| BMDSC | 20 POI patients (<39 years old). (10 patients included) Baseline characteristics not reported |
One ovarian artery by intraarterial catheterism (ASCOT) (6 patients) and stem cells mobilization to peripheral blood by means of GSC-F (4 patients). | -Follicular development in both arms (90–140 days after treatments). -AFC increase in 50% of patients (GSC-F arm) and 66.6% of women (ASCOT arm). -Statistically significant FSH decrease is not observed, although FSH decreased was decreased. -In G-CSF arm: COS initiated in 2/4 women and 1 embryo vitrified. Embryo transfer was performed but pregnancy was not achieved -In the ASCOT arm: COS initiated in 4/6 women, 1 embryo vitrified and transferred, having an ongoing pregnancy. -Menses recovery in 40% of patients and climacteric symptoms decrease in 50% of women. |
Still ongoing. Preliminary data from interim analysis reported (106) |
Herraiz et al., (NCT03535480) |
BM-MSC, bone marrow mesenchymal stem cells; BMDSC, bone marrow derived stem cells; POI, premature ovarian insufficiency; POF, premature ovarian failure; POR, poor ovarian responder; AFC, antral follicle count; AMH, anti-Mullerian hormone; FSH, follicle stimulating hormone; COS, controlled ovarian stimulation; IVF, in vitro fertilization; GSC-F, granulocyte colony-stimulating factor; ASCOT, autologous stem cell ovarian transplantation. Modified from Herraiz et al. (106).