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
|Condition or disease||Intervention/treatment||Phase|
|Asherman's Syndrome Endometrium; Atrophy, Cervix||Biological: Bone Marrow CD133+ Stem Cell Transplantation||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- Biological: Bone Marrow CD133+ Stem Cell Transplantation
Other Name: Neupogen
- Bone Marrow Stem Cell (BMSC) mobilization peripheral blood induced by granulocyte-CSF (G-CSF) 5 mcg/kg sc every 12 hours for 4 days.
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.
- CD133+ cells transplantation into the uterine spiral arterioles by intra-arterial catheterization
- Subsequently Hormonal Replacement Therapy (HRT) will be given to the patients
- Hysteroscopy will be performed 2-3 months after stem cell transplantation
- Embryo transfer will be performed 3-6 months after stem cell transplantation with HRT endometrial preparation
- 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.
- 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
- 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.
- Endometrial thickness prior to the treatment [ Time Frame: 0 ]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
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
|Hospital Clinico y Universitario de Valencia|
|Valencia, Spain, 46010|
|Instituto Valenciano Infertilidad|
|Valencia, Spain, 46015|
|Principal Investigator:||Xavier Santamaria, MD, PhD||Instituto Valenciano Infertilidad|
|Principal Investigator:||Carlos Simon, MD, PhD||Instituto Valenciano Infertilidad|