A new era in reproductive health
If you’ve been diagnosed with Asherman Syndrome or struggle with thin endometrium and have experienced failed implantation, you know how emotionally and physically exhausting the search for effective treatment can be. For decades, traditional options have offered limited success. But now, an innovative therapy called PAULA is offering renewed hope to women worldwide.
What is Asherman Syndrome and why is it so challenging?
Asherman Syndrome is an acquired uterine condition characterized by scar tissue formation inside the uterus, often caused by trauma after surgical procedures such as dilation and curettage (D&C). It affects up to 5% of infertile women, leading to missed periods, pain, and most critically recurrent implantation failure.
Impact on Fertility
The scar tissue disrupts the normal architecture of the endometrial lining, impairing embryo implantation and increasing the risk of miscarriage. Similarly, a thin endometrium, defined as less than 5 mm, is another major barrier to successful pregnancy—even with assisted reproductive technologies.
Traditional treatments: limited but still necessary
Hysteroscopic adhesiolysis
This surgical approach removes adhesions and is the first-line treatment. However, recurrence is common, especially in moderate to severe cases. Many women require multiple surgeries, and outcomes vary widely.
Hormonal therapies
Estrogen is often used post-surgery to stimulate endometrial regrowth. Yet, up to 30% of patients show poor response. Side effects and inconsistent results are common concerns.
Mechanical barriers and PRP
Other treatments include platelet-rich plasma (PRP), intrauterine balloons, or hyaluronic acid gels—used to support endometrial healing. These options provide modest improvements in endometrial thickness but lack long-term impact on live birth rates.
Introducing PAULA: a regenerative breakthrough
What Is PAULA?
PAULA (Patient-specific Autologous endometriaL Advanced therapy) is a stem cell-based regenerative treatment designed specifically for women with Asherman Syndrome and thin endometrium. Developed by leading experts in reproductive medicine, it uses CD133+ autologous bone marrow-derived stem cells to repair and regenerate the uterine lining.
How PAULA Works
- Mobilization: Stimulates the release of stem cells from the bone marrow.
- Extraction (Apheresis): Collects these stem cells from the bloodstream.
- Processing: Isolates CD133+ cells in a GMP-certified lab.
- Infusion: Delivers the stem cells directly to the uterus via a catheter.
- Regeneration: The cells promote angiogenesis and tissue repair, improving endometrial receptivity.
Clinical evidence: What the research shows
PAULA has been tested in a Phase I/II clinical trial in Europe, showing:
- A 30% live birth rate in women previously considered untreatable
- Increased endometrial thickness by an average of 2–3 mm
- Improved menstrual patterns
- High patient satisfaction and safety profile due to the use of autologous cells, minimizing risk of rejection
Compared to traditional methods, PAULA offers long-term regenerative benefits rather than temporary symptomatic relief.
PAULA vs Traditional Options: A side-by-side comparison
|
Feature |
Traditional Options |
PAULA Therapy |
|
Target |
Scar removal or hormone stimulation |
Endometrial regeneration |
|
Effectiveness |
Variable, especially in severe cases |
Clinically proven improvements in fertility |
|
Recurrence |
High (20–60%) |
Reduced due to tissue regeneration |
|
Invasiveness |
Surgery and hormone cycles |
Minimally invasive, outpatient |
|
Personalization |
One-size-fits-all |
Patient-specific autologous therapy |
|
Fertility Outcomes |
Live birth with FIV)(*): 27,1% |
Live birth: 30% in Phase I/II trial, potential to improve |
(*)Registro Nacional de Actividad 2022-Registro SEF
Who should consider PAULA?
- Women aged 30–45 with a history of repeated implantation failure
- Diagnosed with moderate to severe Asherman Syndrome or persistent thin endometrium
- Unresponsive to hormonal therapies or multiple surgeries
- Seeking a non-hormonal, non-surgical, and regenerative approach
A word of caution—and hope
While PAULA represents a major step forward, it’s important to understand that no treatment guarantees success. That said, the science behind PAULA is robust, peer-reviewed, and supported by ongoing clinical trials in Europe and the U.S.
“For many women, PAULA is not just a treatment. It’s a second chance.”
— Dr. Xavier Santamaría, scientific director of PAULA
What comes next?
We are now preparing a Phase III clinical trial to begin by the end of 2025, and PAULA will launch in 2026.