Welcome to our Frequently Asked Questions section. Here you will find clear and thoughtful answers to common inquiries about our regenerative reproductive therapies, treatment processes, and patient care services. This resource is designed to help you better understand Endorenew’s approach and what to expect as you explore options for your reproductive health. Should you have additional questions, please feel free to contact our team for further assistance.
PAULA therapy (Patient AUtologous endometriaL Advanced) is a stem cell-based regenerative treatment with a single goal: to repair your endometrium to give you a real chance of pregnancy. Unlike other approaches, PAULA works on the root of the problem: the regeneration of damaged endometrial tissue.
PAULA is for women with moderate to severe Asherman Syndrome and Thin Endometrium who have undergone surgery, hormone treatments, or even unsuccessful IVF attempts. If you have been told that your endometrium is too thin or that you can’t get pregnant because you don’t respond to traditional treatments, PAULA may be an option for you.
You need to know that it is not a first-choice therapy. If this is your first time facing the diagnosis, there are other treatments you should try first. But if you have already tried everything and are still not getting results, PAULA may be the alternative you were looking for.
PAULA uses your bone marrow stem cells to regenerate the endometrium. The procedure relies on the regenerative capacity of CD133+ cells, a specific type of stem cell, to promote the repair of the damaged endometrium and improve its functionality.
The process step by step:
It is important to know that, once the treatment has been performed, you should wait about 3 months before trying to conceive so that the endometrium recovers the adequate thickness for the viable implantation of an embryo. We are confident that the treatment manages to recover the functionality of your endometrium for at least 15 months, so you will have a window of 12 months to achieve pregnancy.
PAULA therapy is designed to improve the health and receptivity of your endometrium. It does not guarantee pregnancy, but it can significantly increase your chances if your main obstacle has been endometrial unresponsiveness.
Many women who have participated in the trial have been able to regain implantation capacity after PAULA. In fact, up to 30% of the patients treated in our phase II ENTIRE study have achieved a live birth. The best strategy will always be to combine this treatment with a personalized fertility plan, which can include assisted reproduction, if necessary, especially to save time.
No, PAULA therapy is an outpatient procedure. Patients do not need to stay in the hospital during any phase of the treatment. Each visit is designed to be completed within a few hours, allowing patients to return home or to their hotel the same day.
Yes, PAULA therapy has undergone Phase I and II clinical trials, demonstrating safety and efficacy. Since it uses your own stem cells, there is no risk of rejection or serious side effects. Some minor effects may include mild discomfort, minor bruising or cramping after the procedure, but our medical team will guide you every step of the way.
The infusion of stem cells by uterine catheterization allows them to be distributed evenly in the endometrium, reaching the basal layer, where the stem cells responsible for regeneration are found. It is a minimally invasive procedure, and precise enough to maximize the effectiveness of the treatment and ensure that the stem cells reach where they are needed.
Traditional treatments for Asherman syndrome often involve surgical removal of adhesions or hormone therapy. PAULA therapy, however, uses stem cells to promote the body’s natural ability to regenerate endometrial tissue, targeting the root cause of the condition rather than providing temporary relief. This regenerative approach has shown promising results in clinical studies. Standard of care (SOC) involves surgical removal of adhesions (adhesiolysis), often the use of barriers (gels or similar) or hormone therapy, in some cases all of them.
Yes, we will be with you throughout the process so that you do not feel alone. If you have been referred by a healthcare professional, we will stay in regular contact with them to ensure coordinated care. This allows us to be informed about your medical history and any previous treatments. If you have not been referred by a professional, we will still support you every step of the way. We can recommend trusted healthcare professionals close to you who can provide the care you need and support you on your journey towards parenthood. In addition, if you become pregnant, we will guide you on the steps you can take to help reduce the risk of pregnancy-related complications associated with this condition.
PAULA therapy will initially be offered as a private treatment. Once the therapy has been approved and becomes available, we will actively work towards achieving full or partial reimbursement through public healthcare systems and private insurance providers. We recognise that this may be challenging due to the low number of cases, but it is an important goal for us.
PAULA is not yet available, but we are currently identifying potential patients for our Phase III clinical trial that is currently in the design and regulatory review phase.
If you think you may be a candidate and would like more information on how to access it, please send us an email to inquiries@endorenew.com so that we can evaluate you.
