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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000534-35 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Navarrra Hospital (Clinica Universitaria) | OTHER |
| Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán | OTHER |
| Hospitales Universitarios Virgen del Rocío |
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The purpose of this study is to evaluate the safety and efficacy of the sequential infusion of allogeneic mesenchymal stem cells (MSC), expanded "in vitro" with platelet lysate without addition of animal products in the treatment of patients undergoing allo-HSCT who developed one or more cytopenias.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with cytopenia after allo-HSCT | Experimental | Patients with cytopenia after allo-HSCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequential infusion of allogeneic mesenchymal stem cells expanded "in vitro" | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects at the time of infusion and infections after infusion of MSC | All the adverse effects that may arise and possible toxicities (WHO grade) after infusion of the cells were collected. | During the period of infusion of the cells into the patient (an average of one hour) |
| Measure | Description | Time Frame |
|---|---|---|
| Mesenchymal cell efficiency in recovering cytopenia | The efficiency is measured by the recovery of cytopenia after administration of MSC (depending on the original cytopenia) and may be of two types: Complete response:
Partial response:
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Inclusion Criteria:
Patients with hematologic malignancies who have been subjected to allo-HSCT and that are diagnosed with one or more peripheral cytopenias with complete chimerism in bone marrow (determined by molecular-STR-studies). They may include:
Adequate cardiac function assessed from a clinical point of view by the researcher, with no history of ischemic heart disease (angina or myocardial infarction) in the previous 6 months.
Adequate pulmonary function assessed clinically without evidence of severe obstructive or restrictive lung disease.
Patients between 18 and 70 years
Signed informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fermín Sánchez-Guijo Martín, Ph.D | University Clinical Hospital of Salamanca | Principal Investigator |
| José Rifón Roca, Ph.D | University of Navarrra Hospital (Clinica Universitaria) | Principal Investigator |
| José A Pérez Simón, Ph.D | Hospital Virgen del Rocío | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Hospital of Salamanca | Salamanca | Salamanca/Castilla León | 37007 | Spain |
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| Spanish National Health System | OTHER |
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| Monitoring will be from the last infusion of MSCs to the patient until 90 days after the last administration |
| ID | Term |
|---|---|
| D000095542 | Cytopenia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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