Back to resultsClinical Trial In The Treatment Of Allogeneic Post-Transplant Cytopenias With Sequential Infusion Of Allogeneic Mesenchymal Cells Expanded In Vitro
Primary Purpose
Cytopenia
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Sequential infusion of allogeneic mesenchymal stem cells expanded "in vitro"
Sponsored by
About this trial
This is an interventional treatment trial for Cytopenia focused on measuring Cytopenia
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.
- Patients <18 or > 70 years.
- Patients who did not sign the informed consent.
Sites / Locations
- University Clinical Hospital of Salamanca
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with cytopenia after allo-HSCT
Arm Description
Patients with cytopenia after allo-HSCT
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02104440
First Posted
January 22, 2014
Last Updated
March 29, 2017
Sponsor
Red de Terapia Celular
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
1. Study Identification
Unique Protocol Identification Number
NCT02104440
Brief Title
Clinical Trial In The Treatment Of Allogeneic Post-Transplant Cytopenias With Sequential Infusion Of Allogeneic Mesenchymal Cells Expanded In Vitro
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Red de Terapia Celular
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
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytopenia
Keywords
Cytopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with cytopenia after allo-HSCT
Arm Type
Experimental
Arm Description
Patients with cytopenia after allo-HSCT
Intervention Type
Biological
Intervention Name(s)
Sequential infusion of allogeneic mesenchymal stem cells expanded "in vitro"
Primary Outcome Measure Information:
Title
Adverse effects at the time of infusion and infections after infusion of MSC
Description
All the adverse effects that may arise and possible toxicities (WHO grade) after infusion of the cells were collected.
Time Frame
During the period of infusion of the cells into the patient (an average of one hour)
Secondary Outcome Measure Information:
Title
Mesenchymal cell efficiency in recovering cytopenia
Description
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
Time Frame
Monitoring will be from the last infusion of MSCs to the patient until 90 days after the last administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Patients <18 or > 70 years.
Patients who did not sign the informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fermín Sánchez-Guijo Martín, Ph.D
Organizational Affiliation
University Clinical Hospital of Salamanca
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Rifón Roca, Ph.D
Organizational Affiliation
University of Navarrra Hospital (Clinica Universitaria)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José A Pérez Simón, Ph.D
Organizational Affiliation
Hospital Virgen del Rocío
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinical Hospital of Salamanca
City
Salamanca
State/Province
Salamanca/Castilla León
ZIP/Postal Code
37007
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial In The Treatment Of Allogeneic Post-Transplant Cytopenias With Sequential Infusion Of Allogeneic Mesenchymal Cells Expanded In Vitro
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