Graft-vs-Host Disease (GVHD)
Conditions
Keywords
Graft-vs-host disease (GVHD), Mesenchymal stem cell (MSC), Allogeneic hematopoietic stem cell transplant, Allotransplant, Allogenic, Refractory, CSM/EICH2005
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.
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.
Interventions
PROCEDUREMesenchymal stem cell (MSC)
Sponsors
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
University of Salamanca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Determine MSC grafted into the bone marrow (or in other organs). | — |
| Study the influence of MSC infusion on DFS and OS. | — |
| Evaluation of infectious complications after MSC infusion. | — |
| Analyse the influence of MSC infusion on the posttransplant relapse risk of the base disease. | — |
Countries
Spain
Contacts
Primary ContactMercedes Comas, CRA
Outcome results
None listed