Bone Marrow Stem Cell Treatment for Asherman's Syndrome and Endometrial Atrophy
NCT ID: NCT02144987
Last Updated: 2015-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
16 participants
INTERVENTIONAL
2013-04-30
2014-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Severe Asherman Syndrome by Collagen Scaffold Loaded With Autologous Bone Marrow Mononuclear Cells
NCT02680366
Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients
NCT01028794
Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients
NCT00859014
Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome
NCT01562002
Human Amniotic Epithelial Stem Cell in Treatment of Refractory Severe Intrauterine Adhesion
NCT03381807
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
45 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundación para la Investigación del Hospital Clínico de Valencia
OTHER
Instituto Valenciano de Infertilidad, IVI VALENCIA
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xavier Santamaria, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Valenciano Infertilidad
Carlos Simon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Valenciano Infertilidad
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Clinico y Universitario de Valencia
Valencia, Valencia, Spain
Instituto Valenciano Infertilidad
Valencia, Valencia, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chan RW, Schwab KE, Gargett CE. Clonogenicity of human endometrial epithelial and stromal cells. Biol Reprod. 2004 Jun;70(6):1738-50. doi: 10.1095/biolreprod.103.024109. Epub 2004 Feb 6.
Cervello I, Gil-Sanchis C, Mas A, Faus A, Sanz J, Moscardo F, Higueras G, Sanz MA, Pellicer A, Simon C. Bone marrow-derived cells from male donors do not contribute to the endometrial side population of the recipient. PLoS One. 2012;7(1):e30260. doi: 10.1371/journal.pone.0030260. Epub 2012 Jan 19.
Ikoma T, Kyo S, Maida Y, Ozaki S, Takakura M, Nakao S, Inoue M. Bone marrow-derived cells from male donors can compose endometrial glands in female transplant recipients. Am J Obstet Gynecol. 2009 Dec;201(6):608.e1-8. doi: 10.1016/j.ajog.2009.07.026. Epub 2009 Oct 3.
Taylor HS. Endometrial cells derived from donor stem cells in bone marrow transplant recipients. JAMA. 2004 Jul 7;292(1):81-5. doi: 10.1001/jama.292.1.81.
Cervello I, Mas A, Gil-Sanchis C, Peris L, Faus A, Saunders PT, Critchley HO, Simon C. Reconstruction of endometrium from human endometrial side population cell lines. PLoS One. 2011;6(6):e21221. doi: 10.1371/journal.pone.0021221. Epub 2011 Jun 21.
Nagori CB, Panchal SY, Patel H. Endometrial regeneration using autologous adult stem cells followed by conception by in vitro fertilization in a patient of severe Asherman's syndrome. J Hum Reprod Sci. 2011 Jan;4(1):43-8. doi: 10.4103/0974-1208.82360.
March CM. Management of Asherman's syndrome. Reprod Biomed Online. 2011 Jul;23(1):63-76. doi: 10.1016/j.rbmo.2010.11.018. Epub 2010 Dec 4.
Zhang X, Chen CH, Confino E, Barnes R, Milad M, Kazer RR. Increased endometrial thickness is associated with improved treatment outcome for selected patients undergoing in vitro fertilization-embryo transfer. Fertil Steril. 2005 Feb;83(2):336-40. doi: 10.1016/j.fertnstert.2004.09.020.
Sanz-Ruiz R, Gutierrez Ibanes E, Arranz AV, Fernandez Santos ME, Fernandez PL, Fernandez-Aviles F. Phases I-III Clinical Trials Using Adult Stem Cells. Stem Cells Int. 2010 Nov 4;2010:579142. doi: 10.4061/2010/579142.
Makela J, Anttila V, Ylitalo K, Takalo R, Lehtonen S, Makikallio T, Niemela E, Dahlbacka S, Tikkanen J, Kiviluoma K, Juvonen T, Lehenkari P. Acute homing of bone marrow-derived mononuclear cells in intramyocardial vs. intracoronary transplantation. Scand Cardiovasc J. 2009 Dec;43(6):366-73. doi: 10.1080/14017430903045350.
Santamaria X, Cabanillas S, Cervello I, Arbona C, Raga F, Ferro J, Palmero J, Remohi J, Pellicer A, Simon C. Autologous cell therapy with CD133+ bone marrow-derived stem cells for refractory Asherman's syndrome and endometrial atrophy: a pilot cohort study. Hum Reprod. 2016 May;31(5):1087-96. doi: 10.1093/humrep/dew042. Epub 2016 Mar 22.
Cervello I, Gil-Sanchis C, Santamaria X, Cabanillas S, Diaz A, Faus A, Pellicer A, Simon C. Human CD133(+) bone marrow-derived stem cells promote endometrial proliferation in a murine model of Asherman syndrome. Fertil Steril. 2015 Dec;104(6):1552-60.e1-3. doi: 10.1016/j.fertnstert.2015.08.032. Epub 2015 Sep 15.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1101-C-092-JS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.