Treatment of Refractory (Acute or Chronic) Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell
NCT ID: NCT00447460
Last Updated: 2007-03-22
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.
UNKNOWN
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2007-01-31
2009-08-31
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 Refractory Acute Graft-Versus-Host Disease by Sequential Infusion of Allogenic Mesenchymal Stem Cell.
NCT01956903
Treatment of Steroid Resistant GVHD by Infusion MSC
NCT00827398
Mesenchymal Stem Cell Infusion as Treatment for Steroid-Resistant Acute Graft Versus Host Disease (GVHD) or Poor Graft Function
NCT00603330
Clinical Trial In The Treatment Of Allogeneic Post-Transplant Cytopenias With Sequential Infusion Of Allogeneic Mesenchymal Cells Expanded In Vitro
NCT02104440
Allogeneic Mesenchymal Stem Cell for Graft-Versus-Host Disease Treatment
NCT00749164
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
MSC will be infused, by a central venous catheter, to patients diagnosed with GVHD refractory to first-line or subsequent treatment.
All patients will receive the same treatment. MSC suspension will be obtained from the bone marrow aspiration of a family donor and expanded in-vitro in a specific culture medium with autologous donor´s serum and with no animal-derived products.
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.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mesenchymal stem cell (MSC)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adequate cardiac function with no evidence of uncontrolled high blood pressure,congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to the process.
* Adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease.
* Patients with ages between 18 and 65 years.
* Signature of informed consent form is required to be done by patient and donor.
Exclusion Criteria
* Patients with bacterial, viral or fungal infection not being controlled with the adequate treatment.
* Patients with an inadequate cardiac or pulmonary function.
* Patients who, in the investigator´s point of view, are not in situation to tolerate the treatment.
* Patients who do not have the required donor (HLA-identical sibling donor and not HLA-identical sibling donor).
* Pregnant females or childbearing potential who are not on adequate contraceptive measures.
* Patients \<18 or \>65 years.
* Patients who do not sign the informed consent.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
OTHER
University of Salamanca
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Consuelo del Cañizo, MD
Role: STUDY_CHAIR
Haematology Service, University Hospital of Salamanca
José A Pérez-Simón, MD
Role: PRINCIPAL_INVESTIGATOR
Haematology Service, University Hospital of Salamanca
David Varcárcel Ferrerías, MD
Role: PRINCIPAL_INVESTIGATOR
Haematology Service, Santa Creu i Sant Pau Hospital, Barcelona
Carmen Martínez Muñoz, MD
Role: PRINCIPAL_INVESTIGATOR
Haematology Service, Clinic i Provincial Hospital, Barcelona
José Rifón Roca, MD
Role: PRINCIPAL_INVESTIGATOR
Haematology Service, University Clinic of Navarra
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Santa Creu i Sant Pau Hospital
Barcelona, Barcelona, Spain
Clinic i Provincial Hospital
Barcelona, Barcelona, Spain
University Clinic of Navarra
Navarra, Pamplona, Spain
University Hospital of Salamanca
Salamanca, Salamanca, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Perez-Simon JA, Lopez-Villar O, Andreu EJ, Rifon J, Muntion S, Diez Campelo M, Sanchez-Guijo FM, Martinez C, Valcarcel D, Canizo CD. Mesenchymal stem cells expanded in vitro with human serum for the treatment of acute and chronic graft-versus-host disease: results of a phase I/II clinical trial. Haematologica. 2011 Jul;96(7):1072-6. doi: 10.3324/haematol.2010.038356. Epub 2011 Mar 10.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EudraCT Number: 2005-003674-14
Identifier Type: -
Identifier Source: secondary_id
CSM/EICH2005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.