Science That Becomes Life
At Ingenes, we are driven by one conviction: when science advances hand in hand with human care, more families achieve their dream of having a baby. Today, we share a milestone that fills us with pride: the first two babies conceived through the enhanced Endogen protocol using allogeneic mesenchymal stem cells from umbilical cord tissue, developed by Regen IVF, our innovation line in cellular therapies, in partnership with RenewTherapies and CryoHoldCo.
This achievement not only validates years of clinical research but also opens the door for more patients to access the treatment at all our locations, removing the geographic barrier that existed when the protocol relied solely on autologous cells processed in Mexico City. From today, Endogen Stem Cells takes a firm step toward scalability, standardization, and safety, while keeping the language simple: restore the endometrium so it can be a “healthy little cradle” ready to receive the embryo under optimal conditions.
What Is Endogen and What Is Its Goal?
Endogen is a family of protocols created at Ingenes to improve endometrial quality. The endometrium is the inner layer of the uterus where the embryo implants and pregnancy develops. In assisted reproduction, specialists consider the endometrium suitable when it is trilaminar, homogeneous, and reaches ≥7 mm in thickness at the right time.
Some patients do not achieve these conditions due to various causes (scar tissue, inflammation, suboptimal responses to preparation, etc.). Endogen addresses this challenge with two complementary strategies:
- Endogenous Growth Factors: We use Platelet-Rich Plasma (PRP) as a rescue tool when thickness is inadequate; on average it can add ≈1.2 mm, but in severe cases, it is not always enough to reach the 7 mm threshold.
- Endogen Stem Cells (CM): Restores the stem cell niche that nourishes the endometrium from deep uterine layers. Its goal is not only to increase endometrial thickness but to restore the tissue’s biological capacity to grow and regenerate month by month, respond to hormonal stimuli, and finely modulate inflammation during the implantation window.
In short: Endogen CM repopulates the natural stem cell “nursery” of the endometrium so the tissue functions as it should.
Allogeneic Mesenchymal Stem Cells: Explained Simply
- “Stem cells” are generic “blank” cells that can differentiate into various tissue types.
- “Mesenchymal” indicates that, within adult stem cells, these specialize in connective tissues (skin, muscle, bone, endometrial stroma, etc.).
- “Allogeneic” means they come from a donor (not the patient herself). In Endogen CM, stem cells are obtained from donated umbilical cord tissue banked by CryoHoldCo through RenewTherapies.
Why can they be used between unrelated individuals?
Mesenchymal stem cells do not express molecules that trigger immune rejection. Simply put: they do not raise the “rejection flag,” so the recipient’s body accepts them and uses them for repair. This immunomodulatory property is key to their safe use between unrelated patients.
Advantages over autologous cells (from the patient herself):
- Cellular youth: Umbilical cord cells are very young (from newborns´s umbilical cord), associated with higher regenerative potential.
- Logistics and access: With autologous cells, the patient had to be in Mexico City on the exact day for sample collection, immediate processing, and application. With allogeneic cells, vials are ready, sent to any Ingenes location, thawed, and applied in a quick, safe, and standardized procedure.
- Scalability: Continuous availability of qualified vials eliminates bottlenecks and standardizes quality across clinics.
How Does Endogen CM Act on the Endometrium?
The endometrium renews each menstrual cycle thanks to a stem cell niche in deep uterine layers. When this niche is damaged or diminished (e.g., Asherman’s syndrome, refractory thin endometrium), the tissue loses regenerative capacity.
Endogen CM involves reintroducing mesenchymal stem cells into strategic uterine points to repopulate the niche. Expected effects include:
- Tissue regeneration: Restores endometrial architecture (homogeneity, trilaminar pattern, response to estrogens).
- Inflammation modulation: Refines immune activity so that during the implantation window, pro- and anti-inflammatory peaks are correctly orchestrated.
- Functional evidence: In severe Asherman cases, patients who previously did not menstruate have recovered menstrual flow after regeneration—a clinical indicator of active tissue.
The Clinical Procedure: Step by Step (Endogen CM)
- Dose and application: Single application of ≈15 million mesenchymal stem cells via transmyometrial ultrasound-guided injection.
- Duration and anesthesia: Minimally invasive, with sedation; usually lasts 30 minutes.
- Simple logistics: Patient arrives at scheduled time; cells are ready for immediate use. After application, the patient recovers and goes home the same day.
- Response time: As it is a regenerative process, changes are evaluated 10–12 weeks post-procedure (may vary based on severity).
- Next step: Once the endometrium meets criteria (≥7 mm, favorable pattern), endometrial preparation for embryo transfer begins.
Partnerships That Enable Access Across All Locations
RenewTherapies and CryoHoldCo provide donated umbilical cord mesenchymal stem cells, complying with the highest regulatory and quality standards.
What changed? Previously, with autologous cells, patients had to travel to Ingenes in Mexico City on the exact day for collection, isolation, and application. Today, with allogeneic cells, the treatment comes to the patient.
Quality, Safety, and Traceability: How We Ensure It
- Cell identity: Markers confirm mesenchymal stem cell type.
- Donor serology: Tested for HIV, hepatitis, and other infections.
- Safety and sterility: Ensures no contaminants or microorganisms.
- Cell viability: ≥90% live cells after cryopreservation/thawing.
- Full traceability: From donor and bank batch to applied vial and clinical report.
- Enhanced adverse event monitoring: Clear procedures exist to investigate and protect the patient in case of any unforeseen event.
Who Could Benefit from Endogen CM?
Indications are determined after individual medical evaluation. In general, Endogen CM may be considered for:
- Asherman’s syndrome (intrauterine scar tissue)
- Refractory thin endometrium
- Repeated implantation failure with genetically normal embryos and no other identified factors
- Recurrent pregnancy loss where the endometrium plays a significant role
Important: Each case is studied multidisciplinarily, aiming to indicate the right therapy at the right time, maximizing benefit and safety.
Can Endogen Be Combined with Techniques Like IVF MORE®?
Yes, and it makes clinical sense. For patients needing improved egg quality (e.g., IVF MORE®), viable embryos, and a strategic transfer plan, Endogen CM completes the circle: optimizing the “little cradle” to receive that valuable embryo. Proper embryo + excellent endometrium = highest chances for pregnancy.
Research and Publications
The Endogen protocol with autologous cells already has published scientific evidence and has been highly cited internationally.
The allogeneic protocol is under publication. These first births are part of the clinical series that our research team will include in the manuscript. Once published, this note will be updated with references.
What This Breakthrough Means for Our Patients
- Real access: Therapy available at all Ingenes locations
- Time and logistics: Fewer trips, single application, rapid recovery
- Informed hope: Clear path for patients struggling with endometrial quality who already have embryos ready for transfer
FAQ
- Is Endogen CM for all patients?
No. Medical evaluation is required. Typically considered for Asherman’s syndrome, refractory thin endometrium, implantation failures, and certain recurrent pregnancy loss cases. - How many applications are needed?
The standard protocol includes a single application of ≈15 million mesenchymal stem cells. - How long until results are evaluated?
As a regenerative procedure, assessment usually occurs 10–12 weeks post-treatment. Timing may vary with severity. - Is it safe to use donor cells?
Yes. Full quality control, traceability, and regulatory standards are followed. Mesenchymal stem cells also have immunomodulatory properties, making allogeneic use safe.
Can it be combined with FIV/IVF MORE®?
Yes, and it is often recommended. Optimizing both embryo and endometrium increases the chances of achieving your baby.