Bone Marrow Stem Cell Treatment for Asherman's Syndrome and Endometrial Atrophy (BMSCT)

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status and phase: Completed; Phase 4

Conditions: Endometrium; Atrophy, Cervix; Asherman's Syndrome

Treatments: Biological: Bone Marrow CD133+ Stem Cell Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02144987

1101-C-092-JS

Details and patient eligibility

About

The purpose of this study is to determine whether Bone Marrow Stem Cell transplantation may improve Assisted Reproduction Techniques (ART) outcomes in refractive Asherman's Syndrome or Atrophic Endometrium.

Full description

This novel technique refers to the use of CD133+ autologous bone marrow stem-cells to regenerate the endometrium in patients with Asherman's Syndrome, Endometrial Atrophy or any condition that produce a destruction of the endometrium or its de novo creation in a bioengineered uterus.

It requires a previous mobilization in the peripheral blood of CD133+ autologous bone marrow stem cells, subsequent apheresis and transplant of the same cells in the spiral arterioles of the uterus with the aim to regenerate de novo the endometrium. This technique represents a new therapeutical approach for the treatment of endometrial regeneration problems such Asherman Syndrome and the endometrial atrophy since currently no specific treatment for these endometrial pathologies exist.

A prospective experimental non controlled study has been designed in order to assess the effectiveness of these technique as a new tool for treat Asherman's Syndrome and Endometrial Atrophy.

Enrollment: 16 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed of Asherman Syndrome and absence of pregnancy after treatment
• Endometrial atrophy (<6mm) with Implantation Failure
• Age 20-45 years-old
• Normal liver, heart and kidney function
• Presence of menstrual bleeding with Natural Cycle or HRT
• Absence of psychiatric pathology and ability to accomplish the treatment
• β-hCG negative
• Absence of SDT

Exclusion criteria

• Absence of peripheral vein access
• Lack of accomplish inclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)