A novel stem cell therapy has demonstrated significant potential for restoring fertility in women with ovarian failure, according to a retrospective observational study published in Aging (Aging-US). The Stem Cell Regenera treatment achieved oocyte activation in 68.28% of participants and resulted in pregnancies in over 20% of treated women through either spontaneous conception or in vitro fertilization.
Study Design and Patient Population
The research evaluated 145 women aged 26 to 44 years (mean age 39 years) who had not responded to conventional fertility therapies. Participants included women with Diminished Ovarian Reserve (DOR), Poor Ovarian Response (POR), and Premature Ovarian Insufficiency (POI). The study was conducted by researchers from IVI Clinics Alicante, led by Amparo Santamaria.
Low ovarian reserve was defined as Anti-Müllerian Hormone (AMH) levels below 1.2 ng/mL and Antral Follicular Count (AFC) under 5 follicles. Poor Ovarian Response was characterized by low ovarian reserve combined with poor responses in prior IVF cycles, while Premature Ovarian Insufficiency was indicated by menstrual disturbances.
Treatment Protocol and Mechanism
The Stem Cell Regenera treatment involved a two-step process designed to activate dormant follicles and promote ovarian regeneration. First, granulocyte colony-stimulating factor (G-CSF) was used to mobilize the patient's own stem cells into the bloodstream over a 4-day period. This was followed by an injection of Stem Cell Factor-enriched platelet-rich plasma (SCFE-PRP) directly into the ovaries.
At baseline, participants had a mean platelet count of 247,910 x 10¹²/mm³, white blood cell count of 6,025 x 10⁹/mm³, and hemoglobin level of 13 g/dl. The protocol successfully mobilized CD34+ cells in all participants, with adjustments to G-CSF dosage necessary in 30% of women during treatment.
Clinical Outcomes and Efficacy
The primary outcome measure showed oocyte activation in 68.28% of patients, defined as increased follicle growth or a rise in key hormone levels. Among those achieving activation, 7.07% achieved spontaneous pregnancy and 14.14% conceived through IVF. Notably, pregnancy was not achieved either spontaneously or through IVF in women without oocyte activation.
"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," the investigators wrote.
Age-Related Responses and Biomarkers
While differences in efficacy were not observed based on age group overall, a higher rate of oocyte activation was reported in women under 38 years compared to those 38 years and older. The study identified optimal cutoff values for predicting successful oocyte activation: 33,340/mm³ for leukocytes and 5,248.8/mm³ for CD34+ cells.
A positive correlation was observed between white blood cells and CD34+ cells/μl, with a correlation coefficient of 0.465. Women with activation showed a slight increase in the median number of CD34+ cells compared to those without activation.
Safety Profile
The treatment demonstrated a favorable safety profile, with no adverse events reported in 53.1% of participants. Mild symptoms occurred in 32.8% of patients, while moderate to severe adverse effects were observed in only 14.1%. The use of the patient's own cells minimized the risk of immune reactions.
"This protocol successfully mobilized CD34+ cells in all participants without severe adverse effects," the investigators noted. "However, further research is needed to confirm these results."
Clinical Implications
The findings contribute to the growing field of regenerative medicine in reproductive health, offering clinicians additional tools to address infertility in women with complex ovarian conditions. The therapy provides an alternative for patients who have not responded to conventional fertility treatments, potentially expanding treatment options for women with ovarian failure.
The research supports further investigation through larger controlled trials to confirm long-term benefits and identify which patient populations may gain the greatest benefit from this regenerative approach.
