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Trial record 45 of 808 for:    Interventional Studies | mesenchymal

Treatment of Refractory Acute Graft-Versus-Host Disease by Sequential Infusion of Allogenic Mesenchymal Stem Cell. (CSM/EICH2010)

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ClinicalTrials.gov Identifier: NCT01956903
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : October 8, 2013
Sponsor:
Information provided by (Responsible Party):
Grupo Espanol de trasplantes hematopoyeticos y terapia celular

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Graft-Versus-Host Disease Genetic: Allogenic Mesenchymal Stem Cell Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of Treatment of Refractory Acute Graft-Versus-Host Disease After First Line Therapy by Sequential Infusion of Expanded In-Vitro Allogenic Mesenchymal Stem Cell
Study Start Date : January 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013


Arm Intervention/treatment
Experimental: Allogenic Mesenchymal Stem Cell
Sequential Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell (MSC). Dosage 0,7 x 10e6 MSC/Kg/dose (cumulative minimum dose: 2,8 x 10e6 CSM/Kg.
Genetic: Allogenic Mesenchymal Stem Cell
Expanded in-Vitro Allogenic Mesenchymal Stem Cell (authorized by Spain, "Agencia Española de Medicamentos y Productos Sanitarios" with number 06-076)




Primary Outcome Measures :
  1. Adverse effects [ Time Frame: from infusion to 100 days after stem cell transplant ]
    • Infusion related.
    • Infection Rate.


Secondary Outcome Measures :
  1. efficacy [ Time Frame: Acute Graft-Versus-Host Disease period (100 days) ]
    Acute Graft-Versus-Host Disease response rate.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with hematologic malignancies who have undergone allogenic stem cell transplantation and who are diagnosed with acute graft-versus-host-disease refractory to first-line treatment.
  • Patients must have adequate cardiac function without evidence of uncontrolled hypertension, congestive heart failure or myocardial infarction within 6 months prior to the process.
  • Adequate pulmonary function with no evidence of severe obstructive or restrictive pulmonary disease.
  • Be able to understand the information and sign the informed consent.

Exclusion Criteria:

  • Patients with uncontrolled disease or in progress at the time of treatment.
  • Patients with uncontrolled bacterial, viral or fungal infection.
  • Patients with inadequate cardiac or pulmonary function.
  • Patients who do not have the required donor.
  • Women pregnant or at risk of pregnancy by inadequate contraceptive measures.
  • Patients who in the opinion of the investigator are not able to participate in the study.

Information from the National Library of Medicine

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): NCT01956903


Locations
Spain
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Madrid, Spain, 28010
Sponsors and Collaborators
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Investigators
Principal Investigator: Fermín M Sánchez Guijo, MD Hospital Universitario de Salamanca, Salamanca. Spain.
Principal Investigator: Felipe Prosper, MD Clínica Universitaria de Navarra, Spain.
Principal Investigator: Eduardo Olavarría, MD Hospital de Navarra, Spain
Principal Investigator: Rocío Parody, MD Hospital Universitario Virgen del Rocío, Seville, Spain.
Principal Investigator: Carmen Regidor, MD Hospital Universitario Puerta del Hierro, Spain
Principal Investigator: Carmen Martínez, MD Hospital Clinic i Provincial de Barcelona, Spain
Principal Investigator: Rodrigo Martino, MD Hospital de la Santa Creu i Sant Pau, Spain
Principal Investigator: José Antonio Pérez-Simón, MD Hospital Universitario Virgen del Rocío, Seville, Spain.

Responsible Party: Grupo Espanol de trasplantes hematopoyeticos y terapia celular
ClinicalTrials.gov Identifier: NCT01956903     History of Changes
Other Study ID Numbers: CSM/EICH2010
2010-020947-11 ( EudraCT Number )
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: September 2013

Keywords provided by Grupo Espanol de trasplantes hematopoyeticos y terapia celular:
mesenchymal stem cell transplantation

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases