Clinical trial NCT02104440: Clinical Trial In The Treatment Of Allogeneic Post-Transplant Cytopenias With Sequential Infusion Of Allogeneic Mesenchymal Cells Expanded In Vitro
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cytopenia
Keywords: Cytopenia
Lead sponsor: Red de Terapia Celular
Sponsor class: INDUSTRY
Collaborators: name: University of Navarrra Hospital (Clinica Universitaria)
name: Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
name: Hospitales Universitarios Virgen del Rocío
name: Spanish National Health System
First posted: 2014-04-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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:

  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.

Primary outcomes:
measure: Adverse effects at the time of infusion and infections after infusion of MSC
timeFrame: During the period of infusion of the cells into the patient (an average of one hour)
Secondary outcomes:
measure: Mesenchymal cell efficiency in recovering cytopenia
timeFrame: Monitoring will be from the last infusion of MSCs to the patient until 90 days after the last administration
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: University Clinical Hospital of Salamanca
state: Salamanca/Castilla León
Study officials:
affiliation: University Clinical Hospital of Salamanca
name: Fermín Sánchez-Guijo Martín, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Navarrra Hospital (Clinica Universitaria)
name: José Rifón Roca, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen del Rocío
name: José A Pérez Simón, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: