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

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ClinicalTrials.gov Identifier: NCT00447460
Recruitment Status : Unknown
Verified March 2007 by University of Salamanca.
Recruitment status was:  Recruiting
First Posted : March 14, 2007
Last Update Posted : March 22, 2007
Sponsor:
Collaborator:
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
Information provided by:
University of Salamanca

Brief Summary:
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 or disease Intervention/treatment Phase
Graft-vs-Host Disease (GVHD) Procedure: Mesenchymal stem cell (MSC) Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2007
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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.
  2. Efficacy will be evaluated in terms of GVHD response.
  3. Safety will be evaluated in terms of incidence of adverse events and toxicities related to the administration of MSC.

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


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

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): NCT00447460


Contacts
Contact: Mercedes Comas, CRA +(034)915545476 ext 29 mercedes.comas@logitest.es

Locations
Spain
University Clinic of Navarra Recruiting
Navarra, Pamplona, Spain, 31080
Principal Investigator: José Rifón Roca, MD         
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         
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00447460     History of Changes
Other Study ID Numbers: CSM/EICH2005
EudraCT Number: 2005-003674-14
First Posted: March 14, 2007    Key Record Dates
Last Update Posted: March 22, 2007
Last Verified: March 2007

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

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