Allogeneic post-transplant cytopenias.
Conditions
Interventions
Product Name: Mesenchymal stem cells
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: NONE
Other descriptive name: Ex vivo cultured human mesenchymal stem cells
Concentration unit: m
Sponsors
Fundación Castellano Leonesa de Hematología y Hemoterapia (FUCALHH)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with hematologic malignancies who have undergone allo-HSCT and are diagnosed with one or more cytopenias peripheral with full chimerism in bone marrow. They may be included: a. Patients who have received BM or PS as cell source b. Patients who have received cells from a family donor or HLA-matched unrelated c. Patients transplanted with myeloablative or nonmyeloablative conditioning. 2. Patients must have adequate cardiac function without evidence of uncontrolled hypertension, congestive heart failure, angina pectoris or myocardial infarction within 6 months prior to the process. 3. Adequate pulmonary function with no evidence of obstructive or restrictive pulmonary disease severe. 4. Patients between 18 and 70 years 5. Signature of informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1. Patients whose blood disease has not been controlled by the transplantation or is in progress at the time of treatment. 2. Patients who do not have full chimerism in bone marrow 3. Patients with bacterial, viral or fungal infection that is not being controlled with proper treatment. 4. Patients with poor cardiac function and / or pulmonary 5. Patients that on investigator judgment are not in a good position to tolerate treatment 6. Patients who do not have the required donor. 7. Pregnant women or with risk of pregnancy due to inadequate contraceptive measures. 8. Patients 70 years. 9. Patients who do not sign the consent form.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy of the procedure;Timepoint(s) of evaluation of this end point: Efficacy od the procedure is measured in terms of clinical response: ? Recovery hemo-peripheral figures (depending on the cytopenia original): - Complete response: ? Hb> 11 g / dL ? Neutrophils> 1.0x10e9 / L ? Platelets> 100 x10e9 / L Maintained at least 7 days - Partial response: ? Hb 10-11 g / dL ? Neutrophils > 0.5 and 50 and <100 x10e9 / L Maintained at least 7 days | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Analyze the safety of the infusion of allogeneic mesenchymal stem cells (MSCs) expanded "in vitro" with platelet lysate in absence of animal products in the treatment of patients undergoing allo-TPH having developed one or more cytopenias posttransplant. Safety is measured in terms of: ? Adverse effects upon infusion ? Emergence of infectious complications after infusion of MSC.;Secondary Objective: Analyze the efficacy of the procedure measured in terms of clinical response: ? Recovery hemoperiféricas figures ? Duration of response / relapse incidence To analyze the influence of the infusion of MSC in the risk of relapse after transplantation of the underlying disease. To study the influence of the infusion of MSC in overall survival and disease-free survival.;Primary end point(s): Safety of the procedure.;Timepoint(s) of evaluation of this end point: Safety is measured in terms of: ? Adverse effects upon infusion ? Emergence of infectious complications after infusion of MSC. | — |
Countries
Spain
Contacts
Public ContactMayte Fresneda
Gradocell Pharma S.L.
Outcome results
None listed