NCT02144987

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

New Therapeutic Approaches to Treat Asherman's Syndrome and Endometrial Atrophy Based in BM Stem Cells Autologous Transplantation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Asherman's Syndrome
• Endometrium; Atrophy, Cervix

Interventions

Type	Name	Description
BIOLOGICAL	Bone Marrow CD133+ Stem Cell Transplantation	1. Bone Marrow Stem Cell (BMSC) mobilization peripheral blood induced by granulocyte-CSF (G-CSF) 5 mcg/kg sc every 12 hours for 4 days. 2. BMSC recollection with apheresis procedure and positive selection of the CD133+ cells. The selection procedure will be performed for a maximum of 3 hours or until at least 50 million cells are collected. 3. CD133+ cells transplantation into the uterine spiral arterioles by intra-arterial catheterization 4. Subsequently Hormonal Replacement Therapy (HRT) will be given to the patients 5. Hysteroscopy will be performed 2-3 months after stem cell transplantation 6. Embryo transfer will be performed 3-6 months after stem cell transplantation with HRT endometrial preparation

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-05-22
• Last updated: 2015-04-22

Locations

2 sites across 1 country: Spain