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

Sponsor

University of Salamanca (Other)

Overall Status

Unknown status

CT.gov ID

NCT00447460

Collaborator

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

Enrollment

Locations

Duration (Months)

3.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jan 1, 2007

Anticipated Study Completion Date :

Aug 1, 2009

Outcome Measures

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). []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University Clinic of Navarra	Navarra	Pamplona	Spain	31080
2	Santa Creu i Sant Pau Hospital	Barcelona		Spain	08025
3	Clinic i Provincial Hospital	Barcelona		Spain	08036
4	University Hospital of Salamanca	Salamanca		Spain	37007

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