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

Red de Terapia Celular1 site in 1 country15 target enrollmentOctober 2013

ConditionsCytopenia

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Cytopenia
Sponsor: Red de Terapia Celular
Enrollment: 15
Locations: 1
Primary Endpoint: Adverse effects at the time of infusion and infections after infusion of MSC
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

March 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Red de Terapia Celular

Responsible Party

Sponsor

Eligibility Criteria

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:
•Patients who have received as a source of cells MO or SP
•Patients who have received cells from a related donor or unrelated HLA-matched
•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.

Outcomes

Primary Outcomes

Adverse effects at the time of infusion and infections after infusion of MSC

Time Frame: During the period of infusion of the cells into the patient (an average of one hour)

All the adverse effects that may arise and possible toxicities (WHO grade) after infusion of the cells were collected.

Secondary Outcomes

Mesenchymal cell efficiency in recovering cytopenia(Monitoring will be from the last infusion of MSCs to the patient until 90 days after the last administration)