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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I/II Trial in Treating Patients With Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell

Conditions
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Graft-vs-Host Disease (GVHD)

Intervention / Treatment
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* Procedure: Mesenchymal stem cell (MSC)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Mesenchymal stem cell (MSC)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Graft-vs-host disease (GVHD), Mesenchymal stem cell (MSC), Allogeneic hematopoietic stem cell transplant, Allotransplant, Allogenic, Refractory, CSM/EICH2005