Graft-vs-Host Disease (GVHD) Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 15 |
| Est. completion date | August 2009 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Clinic i Provincial Hospital | Barcelona | |
| Spain | Santa Creu i Sant Pau Hospital | Barcelona | |
| Spain | University Clinic of Navarra | Navarra | Pamplona |
| Spain | University Hospital of Salamanca | Salamanca |
| Lead Sponsor | Collaborator |
|---|---|
| University of Salamanca | Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | |||
| Primary | Efficacy will be evaluated in terms of GVHD response. | |||
| Primary | Safety will be evaluated in terms of incidence of adverse events and toxicities related to the administration of MSC. | |||
| Secondary | Evaluation of infectious complications after MSC infusion. | |||
| Secondary | Analyse the influence of MSC infusion on the posttransplant relapse risk of the base disease. | |||
| Secondary | Study the influence of MSC infusion on DFS and OS. | |||
| Secondary | Determine MSC grafted into the bone marrow (or in other organs). |