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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104440
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : March 30, 2017
Sponsor:
Collaborators:
University of Navarrra Hospital (Clinica Universitaria)
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
Hospitales Universitarios Virgen del Rocío
Spanish National Health System
Information provided by (Responsible Party):
Red de Terapia Celular

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.

Condition or disease Intervention/treatment Phase
Cytopenia Biological: Sequential infusion of allogeneic mesenchymal stem cells expanded "in vitro" Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Arm Intervention/treatment
Experimental: Patients with cytopenia after allo-HSCT
Patients with cytopenia after allo-HSCT
Biological: Sequential infusion of allogeneic mesenchymal stem cells expanded "in vitro"



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Mesenchymal cell efficiency in recovering cytopenia [ Time Frame: Monitoring will be from the last infusion of MSCs to the patient until 90 days after the last administration ]

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104440


Locations
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Spain
University Clinical Hospital of Salamanca
Salamanca, Salamanca/Castilla León, Spain, 37007
Sponsors and Collaborators
Red de Terapia Celular
University of Navarrra Hospital (Clinica Universitaria)
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
Hospitales Universitarios Virgen del Rocío
Spanish National Health System
Investigators
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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

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Responsible Party: Red de Terapia Celular
ClinicalTrials.gov Identifier: NCT02104440    
Other Study ID Numbers: CSM/CIT
2013-000534-35 ( EudraCT Number )
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Keywords provided by Red de Terapia Celular:
Cytopenia
Additional relevant MeSH terms:
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Anemia
Leukopenia
Thrombocytopenia
Hematologic Diseases
Leukocyte Disorders
Blood Platelet Disorders