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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Cytopenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with cytopenia after allo-HSCT

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

Interventions

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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:

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No