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

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.

Study Overview

• Status: Completed
• Conditions: Cytopenia
• Intervention / Treatment: Biological: Sequential infusion of allogeneic mesenchymal stem cells expanded "in vitro"

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Salamanca/Castilla León
    • Salamanca, Salamanca/Castilla León, Spain, 37007
      • University Clinical Hospital of Salamanca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients with cytopenia after allo-HSCT	Biological: Sequential infusion of allogeneic mesenchymal stem cells expanded "in vitro"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects at the time of infusion and infections after infusion of MSC	All the adverse effects that may arise and possible toxicities (WHO grade) after infusion of the cells were collected.	During the period of infusion of the cells into the patient (an average of one hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mesenchymal cell efficiency in recovering cytopenia	The efficiency is measured by the recovery of cytopenia after administration of MSC (depending on the original cytopenia) and may be of two types: Complete response: Hb> 10 g / dL; Neutrophils> 1500 Million / L; Platelets> 100.000 Million / L; Maintained at least 7 days Partial response: Hb> 8 and <10 g / dL; Neutrophils> 1000 and <1500 Million / L; Platelets> 50000 and <100.000 Million / L; Maintained at least 7 days	Monitoring will be from the last infusion of MSCs to the patient until 90 days after the last administration

Collaborators and Investigators

• Sponsor: Red de Terapia Celular
• Collaborators: Hospitales Universitarios Virgen del Rocío; University of Navarrra Hospital (Clinica Universitaria); Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán; Spanish National Health System
• Investigators: Principal Investigator: Fermín Sánchez-Guijo Martín, Ph.D, University Clinical Hospital of Salamanca; Principal Investigator: José Rifón Roca, Ph.D, University of Navarrra Hospital (Clinica Universitaria); Principal Investigator: José A Pérez Simón, Ph.D, Hospital Virgen del Rocío

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): March 1, 2017
• Study Completion (ACTUAL): March 1, 2017

Study Registration Dates

• First Submitted: January 22, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (ESTIMATE): April 4, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Cytopenia
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Leukocyte Disorders; Anemia; Thrombocytopenia; Leukopenia
• Other Study ID Numbers: CSM/CIT; 2013-000534-35 (EUDRACT_NUMBER)