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CHICAGO -- Stem cell therapy could help reverse premature ovarian insufficiency, researchers reported here.

According to preliminary results from the ongoing , autologous human bone marrow mesenchymal stem cells were able to aid in the reversal of hypo-estrogenemia, subsequently followed by the resumption of regular menstruation, reported Propser Igboeli, MD, of Augusta University in Georgia and colleagues, at ENDO 2018.

Premature ovarian insufficieny (POI) affects around 1% of reproductive age women under age 40, and often has an unknown cause in the majority of women, but could be a genetic basis for resistant ovary syndrome.

The authors tested stem cell therapy in, and found that human mesenchymal reversed .

While under anesthesia, bone marrow aspirate is harvested from the posterior iliac crest and processed to separate 4-6 cc of mesenchymal stem cells using an FDA-cleared Class 2 medical device (Angel System), which is able to process 160 mL of bone marrow aspirate in 20 minutes. This yields around a total of 120 million total nucleated cells in roughly 20 minutes.

The stem cells were the transplanted into the right ovary laparoscopically, while the left ovary was injected with saline to serve as a control. Due to inactivity, the two patients' ovaries were roughly a third of the size of normally functioning ovaries.

"The methodology I described -- separately, they are standard of care. Hematologists do bone marrow biopsy all the time, this device that we used is FDA approved for other hematological conditions like leukemia and so on, so it's available ... the methodology is so easy, it's nothing unusual," co-author Ayman Al-Hendy, MD, PhD, of the University of Illinois at Chicago explained to 番茄社区. "We inject the ovaries with other things, like when we are doing surgery on the ovary to prevent bleeding for example; we inject the ovary with other hemostatic agents."

Patients were followed up at 1 week after the procedure, as well as 1, 6, 9, and 12 months to assess hormonal parameters, including Anti-Mullerian hormone, follicle-stimulating hormone, luteinizing hormone, estradiol, and progesterone levels. During these follow-ups, transvaginal ultrasounds were conducted to evaluate ovary size.

A week after the procedure, the size of the treated right ovary spiked, which Al-Hendy noted was most likely due to the stem cell injection. After 1 year, the treated ovary in one patient grew to 2.7 cm³, over double the original size of 1.1 cm³ and the controlled ovary's size of 1.4 cm³ at this time. Serum estrogen levels also increased by two-fold when compared to preoperative levels.

Quality of life factors, measured with the North American Menopause Society's questionnaire, had significant improvements across the board.

"The separate pieces, they are not difficult to learn. [This intervention] can be easily adapted in any gynecologic service. The technology is not particularly difficult. That's the goal. Hopefully, we get these results with a larger number of patients ... so others can pursue it and apply the concept," Al-Hendy told 番茄社区.

The next phase of the clinical trial is scheduled to enroll 33 participants. Al-Hendy also said this type of treatment may have application in other reproductive disorders including polycystic ovary syndrome (PCOS) and recurrent pregnancy loss.

But Andrea Dunaif, MD, of the Icahn School of Medicine at Mount Sinai in New York City was not necessarily convinced of widespread application.

"You could see for women who have ovarian failure that giving stem cells that could regenerate, perhaps, oocytes because [of] oocytes exhaustion as a rationale," she told 番茄社区.

For PCOS, what you have is a dysregulation of ovarian hormone production and ovulation, so how stem cells could correct that is unclear," said Dunaif, who was not involved in the study. She added that premature ovarian insufficiency and PCOS are not analogous with respect to prospective treatment methods.

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