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PAULA Cell Therapy

A First-in-Class Regenerative Treatment developed to restore endometrial function in women with Asherman syndrome and refractory thin endometrium.

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When the Endometrium Cannot Regenerate

Severe endometrial damage — such as moderate to severe Asherman syndrome or persistent thin endometrium — remains one of the most difficult conditions in reproductive medicine.

In these patients, the basal layer of the endometrium is compromised, vascularization is reduced, and the tissue loses its regenerative capacity. Conventional surgical and hormonal treatments often provide only temporary improvement, with high recurrence rates and limited restoration of true biological function.

True recovery requires more than structural correction — it requires regeneration.

What is PAULA Cell Therapy?

PAULA Cell Therapy is a regenerative treatment developed by Endorenew based on the intrauterine administration of autologous CD133+ stem cells.

These bone marrow–derived progenitor cells are processed under a rigorous clinical protocol to promote:

  • Angiogenesis
  • Cellular repair
  • Tissue remodeling
  • Functional endometrial recovery

By targeting the underlying regenerative deficit, PAULA Therapy aims to rebuild the biological foundation required for implantation.

Mechanism of Action

Restoring the Endometrial Environment

CD133+ stem cells support vascular growth and tissue repair through paracrine signaling and regenerative activation.

Their administration contributes to:

  • Enhanced vascularization
  • Structural recovery
  • Improved endometrial thickness
  • Increased uterine receptivity

Unlike conventional treatments, PAULA Therapy addresses the cellular and vascular basis of dysfunction.

Treatment Process. How PAULA Cell Therapy Is Performed

1.
  • Diagnosis: Hysteroscopy confirms endometrial damage.
2.
  • Stem Cell Mobilization: CD133+ cells are mobilized from bone marrow (5–7 days).
3.
  • Apheresis Collection: Cells are collected in an outpatient procedure.
4.
  • GMP Processing: Stem cells are purified in a certified laboratory.
5.
  • Uterine Preparation: Adhesiolysis and preventive measures reduce recurrence risk.
6.
  • Targeted Administration: Cells are infused via uterine artery catheterization.
7.
  • Regeneration Phase: Cells stimulate vascularization, repair, and tissue recovery.

Clinical development & regulatory recognition

PAULA Cell Therapy has received:

  • Orphan Drug Designation from the European Medicines Agency (EMA) for Asherman syndrome ((EMA/206895/2017))
  • Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for thin endometrium ((DRU-2017-6131))

Early-phase clinical studies have shown:

  • Increased endometrial thickness
  • Restoration of menstrual function
  • Improved vascularization
  • Achieved pregnancies in refractory cases

These findings support the therapeutic potential of regenerative cellular therapy in severe uterine factor infertility.

Scientific Background

Who may benefit?

PAULA Cell Therapy is intended for women with:

  • Moderate to severe Asherman syndrome
  • Persistent thin endometrium unresponsive to conventional treatment
  • Repeated implantation failure linked to endometrial dysfunction

Each case is evaluated under strict clinical criteria to ensure appropriate patient selection.

Why PAULA Cell Therapy?

  • Autologous approach — minimal immunological risk
  • Regenerative mechanism — not merely corrective
  • Reduced recurrence risk
  • Outpatient, minimally invasive procedure
  • Developed under rigorous scientific and regulatory standards

PAULA Cell Therapy represents a shift in reproductive medicine:

From structural correction

→ To biological restoration

From temporary improvement

→ To regenerative repair

From recurrence

→ To rebuilding function

Therapy Process

The PAULA therapy process includes these steps:

  1. Initial diagnostic hysteroscopy to confirm eligibility for therapy.

  2. Administration of granulocyte colony-stimulating factor (G-CSF) to mobilize CD133+ stem cells into the bloodstream.

  3. Apheresis to collect the mobilized CD133+ stem cells from the blood.

  4. Preparation and enrichment of the stem cells in a Good Manufacturing Practice (GMP)-certified lab.

  5. Infusion of the enriched stem cells into the uterine arteries via catheterization to promote endometrial regeneration.

Clinical Experience

Phase I/II treated 20 patients showing increased endometrial thickness, improved uterine cavity conditions, restored regular menstrual cycles, and successful pregnancies. Endorenew will conduct a Phase III trial planned for mid-2026 in Europe to consolidate these findings.

Safety and Efficacy

PAULA has been tested in clinical trials with promising results. The therapy is safe and effective, with patients experiencing minimal side effects. The use of autologous stem cells reduces the risk of immune reactions, ensuring compatibility and improving overall therapy outcomes.

Benefits

PAULA has shown proven results in clinical trials, demonstrating significant improvements in endometrial thickness, restoration of menstrual function, and positive fertility outcomes. The therapy is well-tolerated with no major adverse effects reported‎‎.