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

April 21, 2015 updated by: Instituto Valenciano de Infertilidad, IVI VALENCIA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Hospital Clinico y Universitario de Valencia
      • Valencia, Spain, 46015
        • Instituto Valenciano Infertilidad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live-birth rate
Time Frame: 15 months
Live birth rate is the percentage of all cycles that lead to live birth, and is the pregnancy rate adjusted for miscarriages and stillbirths.
15 months
Ongoing pregnancy rate
Time Frame: 9 months
Ongoing pregnancy rate is the percentage of all cycles that lead to presence of heartbeat in Ultrasound scan at the end of the first trimester
9 months
Implantation Rate
Time Frame: 6 months
Implantation rate is the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred in a given period.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometrial thickness prior to the treatment
Endometrial thickness measured with Ultrasound in a previous treatment with Hormonal Replacement Therapy
Endometrial Thickness after treatment
Time Frame: 3-6 months
Endometrial thickness measured with Ultrasound with Hormonal Replacement Therapy 3-6 months after Bone Marrow Stem Cell Transplantation
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Collaborators

Fundación para la Investigación del Hospital Clínico de Valencia

Investigators

  • Principal Investigator: Xavier Santamaria, MD, PhD, Instituto Valenciano Infertilidad
  • Principal Investigator: Carlos Simon, MD, PhD, Instituto Valenciano Infertilidad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 19, 2014

First Submitted That Met QC Criteria

May 21, 2014

First Posted (Estimate)

May 22, 2014

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1101-C-092-JS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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