Clinical Trial In The Treatment Of Allogeneic Post-Transplant Cytopenias With Sequential Infusion Of Allogeneic Mesenchymal Cells Expanded In Vitro

The Cellular Therapy Network (TerCel)

Status and phase

Completed

Phase 2

Conditions

Cytopenia

Treatments

Biological: Sequential infusion of allogeneic mesenchymal stem cells expanded "in vitro"

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02104440

CSM/CIT

2013-000534-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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:
1. Patients who have received as a source of cells MO or SP
2. Patients who have received cells from a related donor or unrelated HLA-matched
3. Patients transplanted with myeloablative or non-myeloablative conditioning
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

Patients whose haemopathy has not been controlled by the transplantation or is in progress at the time of treatment.
Patients who do not have complete chimerism in bone marrow (performed within 28 days prior to baseline by molecular study -STR-).
Patients with thrombotic microangiopathy.
Patients with post-transplant cytopenias with toxic origin in relation to antiviral treatment (eg ganciclovir, valganciclovir) without concomitant graft against host disease.
Patients with bacterial, viral or fungal infection that is not being controlled with proper treatment.
Patients with a history of ischemic heart disease (angina or myocardial infarction) in the previous 6 months, and those considered by the investigator does not have adequate cardiac function, evaluated from a clinical point of view.
Patients with poor lung function, evaluated clinically, according to the researcher.
Patients who, in the opinion of the investigator, are not on a good position to tolerate treatment.
Patients who do not have the required donor.
Women pregnant or at risk of pregnancy by contraceptive measures inadequate.
Patients <18 or > 70 years.
Patients who did not sign the informed consent.