CytopeniaPhase 2NCT02104440
Clinical Trial In The Treatment Of Allogeneic Post-Transplant Cytopenias With Sequential Infusion Of Allogeneic Mesenchymal Cells Expanded In Vitro
A Phase 2 study testing Sequential infusion of allogeneic mesenchymal stem cells expanded "in vitro" in people with Cytopenia, run by Red de Terapia Celular at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cytopenia
- What is being tested?
- Sequential infusion of allogeneic mesenchymal stem cells expanded "in vitro"
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2013to Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University Clinical Hospital of Salamanca
Salamanca, Salamanca/Castilla León, 37007
About this study
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.
- Conditions
- Cytopenia
- Being tested
- Sequential infusion of allogeneic mesenchymal stem cells expanded "in vitro"
- Keywords
- Cytopenia
- Medical subject headings
- Cytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential infusion of allogeneic mesenchymal stem cells expanded "in vitro"Biological
| Study group | Role | What they receive |
|---|---|---|
| Patients with cytopenia after allo-HSCT | Experimental | Patients with cytopenia after allo-HSCT Receives: Biological: Sequential infusion of allogeneic mesenchymal stem cells expanded "in vitro" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the period of infusion of the cells into the patient (an average of one hour)
Secondary outcomes (1)
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
Measured: Monitoring will be from the last infusion of MSCs to the patient until 90 days after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Red de Terapia Celular
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Responsible party
- Sponsor
- Investigators
- Fermín Sánchez-Guijo Martín, Ph.D, Principal investigator, University Clinical Hospital of SalamancaJosé Rifón Roca, Ph.D, Principal investigator, University of Navarrra Hospital (Clinica Universitaria)José A Pérez Simón, Ph.D, Principal investigator, Hospital Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104440
- Sponsor's protocol ID
- CSM/CIT
- Other IDs
- 2013-000534-35
- Status last verified
- Mar 2017
- First submitted
- 22 Jan 2014
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial In The Treatment Of Allogeneic Post-Transplant Cytopenias With Sequential Infusion Of Allogeneic Mesenchymal Cells Expanded In Vitro
- ClinicalTrials.gov ID
- NCT02104440
- Acronym / sponsor ID
- CSM/CIT
- Conditions
- Cytopenia
- Keywords
- Cytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Red de Terapia CelularIndustry (pharma, biotech, devices)
- 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
- Study start
- Oct 2013
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cytopenia after allo-HSCT | Experimental | Biological: Sequential infusion of allogeneic mesenchymal stem cells expanded "in vitro"Patients with cytopenia after allo-HSCT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sequential infusion of allogeneic mesenchymal stem cells expanded "in vitro" | Biological | Patients with cytopenia after allo-HSCT |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fermín Sánchez-Guijo Martín, Ph.D principal investigator
University Clinical Hospital of Salamanca
José Rifón Roca, Ph.D principal investigator
University of Navarrra Hospital (Clinica Universitaria)
José A Pérez Simón, Ph.D principal investigator
Hospital Virgen del Rocío
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sequential infusion of allogeneic mesenchymal stem cells expanded "in vitro" in people with Cytopenia, run by Red de Terapia Celular at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.