Chronic Graft-Versus-Host Disease Clinical Trial
— CSM/EICH2010Official title:
Phase 1/2 Study of Treatment of Refractory Acute Graft-Versus-Host Disease After First Line Therapy by Sequential Infusion of Expanded In-Vitro Allogenic Mesenchymal Stem Cell
The purpose of this study is to determine the safety and efficacy of sequential infusion of allogenic mesenchymal stem cells (MSC) expanded "in vitro" in treating patients with acute graft-versus-host disease refractory to first-line therapy.
Status | Completed |
Enrollment | 15 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients with hematologic malignancies who have undergone allogenic stem cell transplantation and who are diagnosed with acute graft-versus-host-disease refractory to first-line treatment. - Patients must have adequate cardiac function without evidence of uncontrolled hypertension, congestive heart failure or myocardial infarction within 6 months prior to the process. - Adequate pulmonary function with no evidence of severe obstructive or restrictive pulmonary disease. - Be able to understand the information and sign the informed consent. Exclusion Criteria: - Patients with uncontrolled disease or in progress at the time of treatment. - Patients with uncontrolled bacterial, viral or fungal infection. - Patients with inadequate cardiac or pulmonary function. - Patients who do not have the required donor. - Women pregnant or at risk of pregnancy by inadequate contraceptive measures. - Patients who in the opinion of the investigator are not able to participate in the study. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Grupo Espanol de trasplantes hematopoyeticos y terapia celular | Madrid |
Lead Sponsor | Collaborator |
---|---|
Grupo Espanol de trasplantes hematopoyeticos y terapia celular |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse effects | Infusion related. Infection Rate. |
from infusion to 100 days after stem cell transplant | Yes |
Secondary | efficacy | Acute Graft-Versus-Host Disease response rate. | Acute Graft-Versus-Host Disease period (100 days) | No |
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