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

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ClinicalTrials.gov Identifier: NCT02144987
Recruitment Status : Completed
First Posted : May 22, 2014
Last Update Posted : April 22, 2015
Sponsor:
Collaborator:
Fundación para la Investigación del Hospital Clínico de Valencia
Information provided by (Responsible Party):
Instituto Valenciano de Infertilidad, IVI VALENCIA

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Asherman's Syndrome Endometrium; Atrophy, Cervix Biological: Bone Marrow CD133+ Stem Cell Transplantation Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: New Therapeutic Approaches to Treat Asherman's Syndrome and Endometrial Atrophy Based in BM Stem Cells Autologous Transplantation
Study Start Date : April 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

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Arms and Interventions
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Intervention Details:
  • 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
    Other Name: Neupogen

Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


Secondary Outcome Measures :
  1. Endometrial thickness prior to the treatment [ Time Frame: 0 ]
    Endometrial thickness measured with Ultrasound in a previous treatment with Hormonal Replacement Therapy

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144987


Locations
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Spain
Hospital Clinico y Universitario de Valencia
Valencia, Spain, 46010
Instituto Valenciano Infertilidad
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
Fundación para la Investigación del Hospital Clínico de Valencia
Investigators
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Principal Investigator: Xavier Santamaria, MD, PhD Instituto Valenciano Infertilidad
Principal Investigator: Carlos Simon, MD, PhD Instituto Valenciano Infertilidad
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier: NCT02144987    
Other Study ID Numbers: 1101-C-092-JS
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Gynatresia
Syndrome
Atrophy
 Disease
Pathologic Processes
Pathological Conditions, Anatomical