Treatment of Refractory Acute Graft-Versus-Host Disease by Sequential Infusion of Allogenic Mesenchymal Stem Cell.
Condition: Chronic Graft-Versus-Host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of sequential infusion of
      allogenic mesenchymal stem cells (MSC) expanded "in vitro" in treating patients with acute
      graft-versus-host disease refractory to first-line therapy.
    

Detailed description: 
      1. Ethical considerations:

             -  The study will be conducted in accordance with the requirements expressed in the
                Declaration of Helsinki (Hong Kong revision, September 1989) and following the
                recommendations of the Good Clinical Practice of the Clinical Trials (document
                111/3976/88, July 1990 ) and Spanish legislation (Royal Decree 561/1993, published
                in April 16th Official State Bulletin "BOE"; May 13th, 1993) laying down the
                requirements for conducting clinical drug trials.

             -  Every subject will receive a written document called "Patient Information Sheet"
                that contains information about the following aspects of clinical trial: a) Aim of
                the study, methodology, study treatment and alternative therapies, expected
                benefits for himself or society, risks of the study and possible adverse events,
                number of visits and additional tests.

                b) Voluntary nature of their participation and ability to withdraw at any time,
                without thereby altering the doctor-patient relationship.

                c) People who have access to the data of the volunteer and how they maintain the
                confidentiality of the data.

                d) How to contact with the investigator if necessary.

             -  The investigator will obtain the informed consent of the subject or, failing that,
                from a legal representative. The subject is preferably expressed written consent
                or, alternatively, orally to the research team independent witnesses who declare in
                writing under its responsibility.

             -  The person participating in the clinical trial or his representative may revoke the
                consent at any time.

        2. Data Access:

             -  In order to ensure the confidentiality of the trial data, only have access to them,
                the researcher and his team, the test monitor and the Clinical Research Ethics
                Committee of the corresponding center or purposes under test and relevant health
                authorities.

             -  Protection of data: The content of the data collection forms and the documents
                generated during the study, will be protected from unauthorized uses by people
                outside the research and, therefore, will be considered strictly confidential and
                will not be disclosed to third parties except to those specified in the preceding
                paragraph.

        3. Data Collection:

             -  Data colection forms will be dated and signed by the authorized principal
                investigator.

             -  Unknown data will be collected as "NA"(not available).

             -  Unusual or extreme results, or that do not match the expected sequence will be
                checked and corrected by initialing, signing and providing an explanation.

             -  Laboratory results that exceed normal limits established by the laboratory of the
                center, should be checked by the researcher and their significance will be noted
                next to the data, by initialing and signing.

        4. Statistical Analysis:

             -  Baseline data will be analyzed using descriptive statistics and demographics (mean,
                median, standard deviation, minimum, maximum, and number of valid cases) for
                quantitative variables and absolute and relative frequencies for categorical
                variables.

             -  The primary efficacy objective is to determine the response rate of graft versus
                host disease (confidence intervals 95%).

             -  The primary safety objective is to determine the incidence of adverse events and
                toxicity related to the administration of the CSM (confidence intervals 95%).

             -  Secondary objectives: analyze overall survival and disease-free survival by the
                Kaplan-Meier method.
    

Intervention name(s): Allogenic Mesenchymal Stem Cell
Intervention type(s): Genetic
Intervention description(s): Expanded in-Vitro Allogenic Mesenchymal Stem Cell (authorized by Spain, "Agencia Española de Medicamentos y Productos Sanitarios" with number 06-076)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mesenchymal stem cell transplantation