Chronic Graft-Versus-Host DiseasePhase 1/2CSM/EICH2010NCT01956903
Treatment of Refractory Acute Graft-Versus-Host Disease by Sequential Infusion of Allogenic Mesenchymal Stem Cell.
A Phase 1/2 study testing Allogenic Mesenchymal Stem Cell in people with Chronic Graft-Versus-Host Disease, run by Grupo Espanol de trasplantes hematopoyeticos y terapia celular at 1 site in Spain.
Trial summary
The purpose of this study is to determine the safety and efficacy of sequential infusion of allogenic mesenchymal stem cells (MSC) expanded "in vitro" in treating patients with acute graft-versus-host disease refractory to first-line therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Graft-Versus-Host Disease
- What is being tested?
- Allogenic Mesenchymal Stem Cell
- 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
- Jan 2010to Sep 2013
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hematologic malignancies who have undergone allogenic stem cell transplantation and who are diagnosed with acute graft-versus-host-disease refractory to first-line treatment.
- Patients must have adequate cardiac function without evidence of uncontrolled hypertension, congestive heart failure or myocardial infarction within 6 months prior to the process.
- Adequate pulmonary function with no evidence of severe obstructive or restrictive pulmonary disease.
- Be able to understand the information and sign the informed consent.
Who cannot join
- Patients with uncontrolled disease or in progress at the time of treatment.
- Patients with uncontrolled bacterial, viral or fungal infection.
- Patients with inadequate cardiac or pulmonary function.
- Patients who do not have the required donor.
- Women pregnant or at risk of pregnancy by inadequate contraceptive measures.
- Patients who in the opinion of the investigator are not able to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Madrid, Madrid, 28010
About this study
Official title: Phase 1/2 Study of Treatment of Refractory Acute Graft-Versus-Host Disease After First Line Therapy by Sequential Infusion of Expanded In-Vitro Allogenic Mesenchymal Stem Cell
The purpose of this study is to determine the safety and efficacy of sequential infusion of allogenic mesenchymal stem cells (MSC) expanded "in vitro" in treating patients with acute graft-versus-host disease refractory to first-line therapy.
Read the detailed description
- Ethical considerations:
- The study will be conducted in accordance with the requirements expressed in the Declaration of Helsinki (Hong Kong revision, September 1989) and following the recommendations of the Good Clinical Practice of the Clinical Trials (document 111/3976/88, July 1990 ) and Spanish legislation (Royal Decree 561/1993, published in April 16th Official State Bulletin "BOE"; May 13th, 1993) laying down the requirements for conducting clinical drug trials.
- Every subject will receive a written document called "Patient Information Sheet" that contains information about the following aspects of clinical trial: a) Aim of the study, methodology, study treatment and alternative therapies, expected benefits for himself or society, risks of the study and possible adverse events, number of visits and additional tests.
- Voluntary nature of their participation and ability to withdraw at any time, without thereby altering the doctor-patient relationship.
- People who have access to the data of the volunteer and how they maintain the confidentiality of the data.
- How to contact with the investigator if necessary.
- The investigator will obtain the informed consent of the subject or, failing that, from a legal representative. The subject is preferably expressed written consent or, alternatively, orally to the research team independent witnesses who declare in writing under its responsibility.
- The person participating in the clinical trial or his representative may revoke the consent at any time.
- Data Access:
- In order to ensure the confidentiality of the trial data, only have access to them, the researcher and his team, the test monitor and the Clinical Research Ethics Committee of the corresponding center or purposes under test and relevant health authorities.
- Protection of data: The content of the data collection forms and the documents generated during the study, will be protected from unauthorized uses by people outside the research and, therefore, will be considered strictly confidential and will not be disclosed to third parties except to those specified in the preceding paragraph.
- Data Collection:
- Data colection forms will be dated and signed by the authorized principal investigator.
- Unknown data will be collected as "NA"(not available).
- Unusual or extreme results, or that do not match the expected sequence will be checked and corrected by initialing, signing and providing an explanation.
- Laboratory results that exceed normal limits established by the laboratory of the center, should be checked by the researcher and their significance will be noted next to the data, by initialing and signing.
- Statistical Analysis:
- Baseline data will be analyzed using descriptive statistics and demographics (mean, median, standard deviation, minimum, maximum, and number of valid cases) for quantitative variables and absolute and relative frequencies for categorical variables.
- The primary efficacy objective is to determine the response rate of graft versus host disease (confidence intervals 95%).
- The primary safety objective is to determine the incidence of adverse events and toxicity related to the administration of the CSM (confidence intervals 95%).
- Secondary objectives: analyze overall survival and disease-free survival by the Kaplan-Meier method.
- Conditions
- Chronic Graft-Versus-Host Disease
- Being tested
- Allogenic Mesenchymal Stem Cell
- Keywords
- mesenchymal stem cell transplantation
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogenic Mesenchymal Stem CellGenetic
Expanded in-Vitro Allogenic Mesenchymal Stem Cell (authorized by Spain, "Agencia Española de Medicamentos y Productos Sanitarios" with number 06-076)
| Study group | Role | What they receive |
|---|---|---|
| Allogenic Mesenchymal Stem Cell | Experimental | Sequential Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell (MSC). Dosage 0,7 x 10e6 MSC/Kg/dose (cumulative minimum dose: 2,8 x 10e6 CSM/Kg. Receives: Genetic: Allogenic Mesenchymal Stem Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effects
- Infusion related.
- Infection Rate.
Measured: from infusion to 100 days after stem cell transplant
Secondary outcomes (1)
efficacy
Acute Graft-Versus-Host Disease response rate.
Measured: Acute Graft-Versus-Host Disease period (100 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJan 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft-Versus-Host DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol de trasplantes hematopoyeticos y terapia celular
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fermín M Sánchez Guijo, MD, Principal investigator, Hospital Universitario de Salamanca, Salamanca. Spain.Felipe Prosper, MD, Principal investigator, Clínica Universitaria de Navarra, Spain.Eduardo Olavarría, MD, Principal investigator, Hospital de Navarra, SpainRocío Parody, MD, Principal investigator, Hospital Universitario Virgen del Rocío, Seville, Spain.Carmen Regidor, MD, Principal investigator, Hospital Universitario Puerta del Hierro, SpainCarmen Martínez, MD, Principal investigator, Hospital Clinic i Provincial de Barcelona, SpainRodrigo Martino, MD, Principal investigator, Hospital de la Santa Creu i Sant Pau, SpainJosé Antonio Pérez-Simón, MD, Principal investigator, Hospital Universitario Virgen del Rocío, Seville, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956903
- Sponsor's protocol ID
- CSM/EICH2010
- Other IDs
- 2010-020947-11
- Acronym
- CSM/EICH2010
- Status last verified
- Sep 2013
- First submitted
- 30 Sep 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of Treatment of Refractory Acute Graft-Versus-Host Disease After First Line Therapy by Sequential Infusion of Expanded In-Vitro Allogenic Mesenchymal Stem Cell
- ClinicalTrials.gov ID
- NCT01956903
- Acronym / sponsor ID
- CSM/EICH2010 / CSM/EICH2010
- Conditions
- Chronic Graft-Versus-Host Disease
- Keywords
- mesenchymal stem cell transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Grupo Espanol de trasplantes hematopoyeticos y terapia celularUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 Oct 2013 (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 determine the safety and efficacy of sequential infusion of allogenic mesenchymal stem cells (MSC) expanded "in vitro" in treating patients with acute graft-versus-host disease refractory to first-line therapy.
Detailed description
- Ethical considerations:
- The study will be conducted in accordance with the requirements expressed in the Declaration of Helsinki (Hong Kong revision, September 1989) and following the recommendations of the Good Clinical Practice of the Clinical Trials (document 111/3976/88, July 1990 ) and Spanish legislation (Royal Decree 561/1993, published in April 16th Official State Bulletin "BOE"; May 13th, 1993) laying down the requirements for conducting clinical drug trials.
- Every subject will receive a written document called "Patient Information Sheet" that contains information about the following aspects of clinical trial: a) Aim of the study, methodology, study treatment and alternative therapies, expected benefits for himself or society, risks of the study and possible adverse events, number of visits and additional tests.
- Voluntary nature of their participation and ability to withdraw at any time, without thereby altering the doctor-patient relationship.
- People who have access to the data of the volunteer and how they maintain the confidentiality of the data.
- How to contact with the investigator if necessary.
- The investigator will obtain the informed consent of the subject or, failing that, from a legal representative. The subject is preferably expressed written consent or, alternatively, orally to the research team independent witnesses who declare in writing under its responsibility.
- The person participating in the clinical trial or his representative may revoke the consent at any time.
- Data Access:
- In order to ensure the confidentiality of the trial data, only have access to them, the researcher and his team, the test monitor and the Clinical Research Ethics Committee of the corresponding center or purposes under test and relevant health authorities.
- Protection of data: The content of the data collection forms and the documents generated during the study, will be protected from unauthorized uses by people outside the research and, therefore, will be considered strictly confidential and will not be disclosed to third parties except to those specified in the preceding paragraph.
- Data Collection:
- Data colection forms will be dated and signed by the authorized principal investigator.
- Unknown data will be collected as "NA"(not available).
- Unusual or extreme results, or that do not match the expected sequence will be checked and corrected by initialing, signing and providing an explanation.
- Laboratory results that exceed normal limits established by the laboratory of the center, should be checked by the researcher and their significance will be noted next to the data, by initialing and signing.
- Statistical Analysis:
- Baseline data will be analyzed using descriptive statistics and demographics (mean, median, standard deviation, minimum, maximum, and number of valid cases) for quantitative variables and absolute and relative frequencies for categorical variables.
- The primary efficacy objective is to determine the response rate of graft versus host disease (confidence intervals 95%).
- The primary safety objective is to determine the incidence of adverse events and toxicity related to the administration of the CSM (confidence intervals 95%).
- Secondary objectives: analyze overall survival and disease-free survival by the Kaplan-Meier method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogenic Mesenchymal Stem Cell | Experimental | Genetic: Allogenic Mesenchymal Stem CellSequential Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell (MSC). Dosage 0,7 x 10e6 MSC/Kg/dose (cumulative minimum dose: 2,8 x 10e6 CSM/Kg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with hematologic malignancies who have undergone allogenic stem cell transplantation and who are diagnosed with acute graft-versus-host-disease refractory to first-line treatment.
- Patients must have adequate cardiac function without evidence of uncontrolled hypertension, congestive heart failure or myocardial infarction within 6 months prior to the process.
- Adequate pulmonary function with no evidence of severe obstructive or restrictive pulmonary disease.
- Be able to understand the information and sign the informed consent.
Key exclusion criteria (6 listed)
- Patients with uncontrolled disease or in progress at the time of treatment.
- Patients with uncontrolled bacterial, viral or fungal infection.
- Patients with inadequate cardiac or pulmonary function.
- Patients who do not have the required donor.
- Women pregnant or at risk of pregnancy by inadequate contraceptive measures.
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 |
|---|---|---|
| Allogenic Mesenchymal Stem CellExpanded in-Vitro Allogenic Mesenchymal Stem Cell (authorized by Spain, "Agencia Española de Medicamentos y Productos Sanitarios" with number 06-076) | Genetic | Allogenic Mesenchymal Stem Cell |
Primary outcome
Adverse effects
Time frame: from infusion to 100 days after stem cell transplant
* Infusion related. * Infection Rate.
1 secondary outcome
efficacy
Time frame: Acute Graft-Versus-Host Disease period (100 days)
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 8 Oct 2013.
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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 M Sánchez Guijo, MD principal investigator
Hospital Universitario de Salamanca, Salamanca. Spain.
Felipe Prosper, MD principal investigator
Clínica Universitaria de Navarra, Spain.
Eduardo Olavarría, MD principal investigator
Hospital de Navarra, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogenic Mesenchymal Stem Cell in people with Chronic Graft-Versus-Host Disease, run by Grupo Espanol de trasplantes hematopoyeticos y 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 4 inclusion and 6 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 8 Oct 2013. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (time frame: from infusion to 100 days after stem cell transplant). 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 8 Oct 2013.