Stem cell therapy found to boost fertility in women with ovarian failure

Stem cell therapy found to boost fertility in women with ovarian failure | Image Credit: © Anusorn – © Anusorn – stock.adobe.com.

Stem cell treatment may be effective for fertility restoration in women with ovarian failure, according to a recent study published in Aging (Aging-US).¹

This method was associated with a 70% oocyte activation rate and spontaneous pregnancy in 7% of participants. Additionally, 14% achieved pregnancy through in vitro fertilization (IVF). This highlighted stimulation of ovarian activity to increase the odds of conception through stem cell therapy.

“Our findings offer valuable information on the effectiveness and safety of the Stem Cell Regenera protocol in a diverse, real-world population, which is representative of the patients encountered in daily clinical practice,” wrote investigators.

Promise of stem cell therapy

The retrospective observational study assessed the safety and efficacy of Stem Cell Regenera treatment in routine clinical practice.² Participants included women with Diminished Ovarian Reserve (DOR), Poor Ovarian Response (POR), and Premature Ovarian Insufficiency (POI).

Anti-Müllerian Hormone (AMH) levels and Antral Follicular Count (AFC) were measured to determine ovarian reserve, with low reserve defined as AMH levels below 1.2 ng/mL and AFC under 5 follicles. This indicated DOR, while POR was defined by a low ovarian reserve and poor responses in prior IVF cycles. Finally, POI was indicated by menstrual disturbance.

Leukocytes and CD34+ were assessed for activation criteria, measured by linking these factors on day 5. An increase in AFC by at least 3 follicles based on ultrasound indicated a positive response. Adverse effects were used to measure safety, reported as none, mild moderate, and severe.

Analytical parameters of each patient before and after treatment were reported as secondary outcomes. The Stem Cell Regenera treatment included the use of granulocyte colony-stimulating factor (G-CSF) to mobilize stem cells into the bloodstream. This was followed by Stem Cell Factor-enriched platelet-rich plasma (SCFE-PRP) injection.

Clinical outcomes and mobilization

There were 145 women aged a mean of 39 years included in the final analysis. At baseline, a platelet count of 247,910 x 10¹²/mm³ and mean white blood cell count of 6,025 x 10⁹/mm³ were reported. Additionally, the mean hemoglobin was 13 g/dl.

Oocyte activation was reported in 68.28% of patients, with 7.07% achieving spontaneous gestation and 14.14% achieving gestation after IVF. Pregnancy was not achieved either spontaneously or through IVF in women without oocyte activation.

All patients reported successful CD34+ cell mobilization, with a slight increase in the median number of CD34+ cells/μ among women with activation vs those without activation. Adjustments to the G-CSF dosage were necessary in 30% of women during the 4-day treatment.

Differences in efficacy were not observed based on age group. However, a higher rate of oocyte activation was reported in women aged under 38 years vs those aged 38 years and older. Additionally, a positive correlation was reported between white blood cells and CD34+ cells/μl, with a correlation coefficient of 0.465.

Leukocyte cutoff

The optimal cutoff for leukocytes to achieve a high rate of oocyte activation was 33,340 / mm3. For CD34+, the optimal cutoff point was 5248.8/mm3.

No adverse events were reported in 53.1% of participants, mild in 32.8%, and moderate to severe in 14.1%. This indicated that most women experienced none or mild symptoms.

These results indicated promise for the Stem Cell Regenera treatment to achieve oocyte activation in approximately 70% of women. Additionally, the treatment displayed efficacy for achieving pregnancy spontaneously and through IVF.

“This protocol successfully mobilized CD34+ cells in all participants without severe adverse effects,” wrote investigators. “However, further research is needed to confirm these results.”

References

1. Stem cell treatment shows potential for restoring fertility in women with ovarian failure. Impact Journals LLC. July 21, 2025. Accessed July 23, 2025. https://www.eurekalert.org/news-releases/1091927.
2. Santamaria A, Ballester A, Muñoz M. Enhancing oocyte activation in women with ovarian failure: clinical outcomes of the Stem Cell Regenera study using G-CSF mobilization of peripheral blood stem cells and intraovarian injection of stem cell factor-enriched platelet rich plasma in real-world-practice. Aging. 2025. doi:10.18632/aging.206274