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

NCT02144987 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-04-22

No results posted yet for this study

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.

Conditions

  • Asherman's Syndrome
  • Endometrium; Atrophy, Cervix

Interventions

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

Sponsors & Collaborators

  • Fundación para la Investigación del Hospital Clínico de Valencia

    collaborator OTHER

  • Instituto Valenciano de Infertilidad, IVI VALENCIA

    lead OTHER

Principal Investigators

  • Xavier Santamaria, MD, PhD · Instituto Valenciano Infertilidad

  • Carlos Simon, MD, PhD · Instituto Valenciano Infertilidad

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02144987 on ClinicalTrials.gov