Treatment of Refractory (Acute or Chronic) Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell

This study is currently recruiting participants.

Verified by University of Salamanca, March 2007

Sponsors and Collaborators:	University of Salamanca Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
Information provided by:	University of Salamanca
ClinicalTrials.gov Identifier:	NCT00447460

Purpose

Clinical trial based on the use of a new therapeutic strategy (MSC infusion) for the treatment of patients who have developed a GVHD refractory to the usual therapeutic measures after undergoing an allogenic hematopoietic stem cell transplant.

Condition	Intervention	Phase
Graft-vs-Host Disease (GVHD)	Procedure: Mesenchymal stem cell (MSC)	Phase I Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Trial in Treating Patients With Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell

Further study details as provided by University of Salamanca:

Primary Outcome Measures:

Determine the safety/efficacy of expanded in-vitro allogenic mesenchymal stem cell infusion in patients developing a GVHD refractory to the usual therapeutic measures after undergoing an allogeneic hematopoietic stem cell transplant.
Efficacy will be evaluated in terms of GVHD response.
Safety will be evaluated in terms of incidence of adverse events and toxicities related to the administration of MSC.

Secondary Outcome Measures:

Evaluation of infectious complications after MSC infusion.
Analyse the influence of MSC infusion on the posttransplant relapse risk of the base disease.
Study the influence of MSC infusion on DFS and OS.
Determine MSC grafted into the bone marrow (or in other organs).

Estimated Enrollment:	15
Study Start Date:	January 2007
Estimated Study Completion Date:	August 2009

Detailed Description:

This is a multicenter, single dose study of allogenic mesenchymal stem cell (1-2 x 10^6 MSC/Kg recipient´s bodyweight).

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with hematological malignancies who had been undergone an allogenic hematopoietic stem cell transplant and diagnosed with GVHD refractory to a usual treatment.
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 whose hematopathology has not been controlled by the transplant or is in progress.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447460

Contacts

Contact: Mercedes Comas, CRA

+(034)915545476 ext 29

mercedes.comas@logitest.es

Locations

Spain
Santa Creu i Sant Pau Hospital	Recruiting
Barcelona, Spain, 08025
Principal Investigator: David Varcárcel Ferrerías, MD
Clinic i Provincial Hospital	Recruiting
Barcelona, Spain, 08036
Principal Investigator: Carmen Martínez Muñoz, MD
University Hospital of Salamanca	Recruiting
Salamanca, Spain, 37007
Principal Investigator: Consuelo del Cañizo, MD
Principal Investigator: José A Pérez-Simón, MD
Spain, Pamplona
University Clinic of Navarra	Recruiting
Navarra, Pamplona, Spain, 31080
Principal Investigator: José Rifón Roca, MD

Sponsors and Collaborators

University of Salamanca

Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán

Investigators

Study Chair:	Consuelo del Cañizo, MD	Haematology Service, University Hospital of Salamanca
Principal Investigator:	José A Pérez-Simón, MD	Haematology Service, University Hospital of Salamanca
Principal Investigator:	David Varcárcel Ferrerías, MD	Haematology Service, Santa Creu i Sant Pau Hospital, Barcelona
Principal Investigator:	Carmen Martínez Muñoz, MD	Haematology Service, Clinic i Provincial Hospital, Barcelona
Principal Investigator:	José Rifón Roca, MD	Haematology Service, University Clinic of Navarra

More Information

Study ID Numbers:	CSM/EICH2005, EudraCT Number: 2005-003674-14
Study First Received:	March 13, 2007
Last Updated:	March 20, 2007
ClinicalTrials.gov Identifier:	NCT00447460
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by University of Salamanca:

Graft-vs-host disease (GVHD)
Mesenchymal stem cell (MSC)
Allogeneic hematopoietic stem cell transplant
Allotransplant

Allogenic
Refractory
CSM/EICH2005

Study placed in the following topic categories:

Graft versus host disease
Graft vs Host Disease
Homologous wasting disease

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009