Graft-vs-Host Disease (GVHD)Phase 1/2NCT00447460
Treatment of Refractory (Acute or Chronic) Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell
A Phase 1/2 study testing Mesenchymal stem cell (MSC) in people with Graft-vs-Host Disease (GVHD), run by University of Salamanca at 4 sites in Spain.
Trial summary
Clinical trial based on the use of a new therapeutic strategy (MSC infusion) for the treatment of patients who have developed a GVHD refractory to the usual therapeutic measures after undergoing an allogenic hematopoietic stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graft-vs-Host Disease (GVHD)
- What is being tested?
- Mesenchymal stem cell (MSC)
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 4 sitesSpain
- Study dates
- Jan 2007to Aug 2009
- 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 hematological malignancies who had been undergone an allogenic hematopoietic stem cell transplant and diagnosed with GVHD refractory to a usual treatment.
- Adequate cardiac function with no evidence of uncontrolled high blood pressure,congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to the process.
- Adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease.
- Patients with ages between 18 and 65 years.
- Signature of informed consent form is required to be done by patient and donor.
Who cannot join
- Patients whose hematopathology has not been controlled by the transplant or is in progress.
- Patients with bacterial, viral or fungal infection not being controlled with the adequate treatment.
- Patients with an inadequate cardiac or pulmonary function.
- Patients who, in the investigator´s point of view, are not in situation to tolerate the treatment.
- Patients who do not have the required donor (HLA-identical sibling donor and not HLA-identical sibling donor).
- Pregnant females or childbearing potential who are not on adequate contraceptive measures.
- Patients <18 or >65 years.
- Patients who do not sign the informed consent.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites, 4 recruiting
- Recruiting
Santa Creu i Sant Pau Hospital
Barcelona, Barcelona, 08025
David Varcárcel Ferrerías, MD
- Recruiting
Clinic i Provincial Hospital
Barcelona, Barcelona, 08036
Carmen Martínez Muñoz, MD
- Recruiting
University Clinic of Navarra
Navarra, Pamplona, 31080
José Rifón Roca, MD
- Recruiting
University Hospital of Salamanca
Salamanca, Salamanca, 37007
Consuelo del Cañizo, MD
José A Pérez-Simón, MD
About this study
Official title: A Phase I/II Trial in Treating Patients With Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell
Clinical trial based on the use of a new therapeutic strategy (MSC infusion) for the treatment of patients who have developed a GVHD refractory to the usual therapeutic measures after undergoing an allogenic hematopoietic stem cell transplant.
Read the detailed description
This is a multicenter, single dose study of allogenic mesenchymal stem cell (1-2 x 10^6 MSC/Kg recipient´s bodyweight).
MSC will be infused, by a central venous catheter, to patients diagnosed with GVHD refractory to first-line or subsequent treatment.
All patients will receive the same treatment. MSC suspension will be obtained from the bone marrow aspiration of a family donor and expanded in-vitro in a specific culture medium with autologous donor´s serum and with no animal-derived products.
- Conditions
- Graft-vs-Host Disease (GVHD)
- Being tested
- Mesenchymal stem cell (MSC)
- Keywords
- Graft-vs-host disease (GVHD), Mesenchymal stem cell (MSC), Allogeneic hematopoietic stem cell transplant, Allotransplant, Allogenic, Refractory, CSM/EICH2005
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cell (MSC)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety/efficacy of expanded in-vitro allogenic mesenchymal stem cell infusion in patients developing a GVHD refractory to the usual therapeutic measures after undergoing an allogeneic hematopoietic stem cell transplant.
Efficacy will be evaluated in terms of GVHD response.
Safety will be evaluated in terms of incidence of adverse events and toxicities related to the administration of MSC.
Secondary outcomes (4)
Evaluation of infectious complications after MSC infusion.
Analyse the influence of MSC infusion on the posttransplant relapse risk of the base disease.
Study the influence of MSC infusion on DFS and OS.
Determine MSC grafted into the bone marrow (or in other organs).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startJan 2007
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft-vs-Host Disease (GVHD)Studies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Collaborators
- Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
- Investigators
- Consuelo del Cañizo, MD, Study chair, Haematology Service, University Hospital of SalamancaJosé A Pérez-Simón, MD, Principal investigator, Haematology Service, University Hospital of SalamancaDavid Varcárcel Ferrerías, MD, Principal investigator, Haematology Service, Santa Creu i Sant Pau Hospital, BarcelonaCarmen Martínez Muñoz, MD, Principal investigator, Haematology Service, Clinic i Provincial Hospital, BarcelonaJosé Rifón Roca, MD, Principal investigator, Haematology Service, University Clinic of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447460
- Sponsor's protocol ID
- CSM/EICH2005
- Other IDs
- EudraCT Number: 2005-003674-14
- Status last verified
- Mar 2007
- First submitted
- 13 Mar 2007
- Last updated
- 22 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Perez-Simon JA, Lopez-Villar O, Andreu EJ, Rifon J, Muntion S, Diez Campelo M, Sanchez-Guijo FM, Martinez C, Valcarcel D, Canizo CD. Mesenchymal stem cells expanded in vitro with human serum for the treatment of acute and chronic graft-versus-host disease: results of a phase I/II clinical trial. Haematologica. 2011 Jul;96(7):1072-6. doi: 10.3324/haematol.2010.038356. Epub 2011 Mar 10.
PubMed 21393326
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial in Treating Patients With Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell
- ClinicalTrials.gov ID
- NCT00447460
- Acronym / sponsor ID
- CSM/EICH2005
- Conditions
- Graft-vs-Host Disease (GVHD)
- Keywords
- Graft-vs-host disease (GVHD), Mesenchymal stem cell (MSC), Allogeneic hematopoietic stem cell transplant, Allotransplant, Allogenic, Refractory, CSM/EICH2005
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Collaborators
- Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
- Study start
- Jan 2007
- Study completion
- Aug 2009 (estimated)
- First posted
- 14 Mar 2007 (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.
Clinical trial based on the use of a new therapeutic strategy (MSC infusion) for the treatment of patients who have developed a GVHD refractory to the usual therapeutic measures after undergoing an allogenic hematopoietic stem cell transplant.
Detailed description
This is a multicenter, single dose study of allogenic mesenchymal stem cell (1-2 x 10^6 MSC/Kg recipient´s bodyweight).
MSC will be infused, by a central venous catheter, to patients diagnosed with GVHD refractory to first-line or subsequent treatment.
All patients will receive the same treatment. MSC suspension will be obtained from the bone marrow aspiration of a family donor and expanded in-vitro in a specific culture medium with autologous donor´s serum and with no animal-derived products.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with hematological malignancies who had been undergone an allogenic hematopoietic stem cell transplant and diagnosed with GVHD refractory to a usual treatment.
- Adequate cardiac function with no evidence of uncontrolled high blood pressure,congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to the process.
- Adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease.
- Patients with ages between 18 and 65 years.
- Signature of informed consent form is required to be done by patient and donor.
Key exclusion criteria (8 listed)
- Patients whose hematopathology has not been controlled by the transplant or is in progress.
- Patients with bacterial, viral or fungal infection not being controlled with the adequate treatment.
- Patients with an inadequate cardiac or pulmonary function.
- Patients who, in the investigator´s point of view, are not in situation to tolerate the treatment.
- Patients who do not have the required donor (HLA-identical sibling donor and not HLA-identical sibling donor).
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 |
|---|---|---|
| Mesenchymal stem cell (MSC) | Procedure or surgery | – |
Primary outcome
Determine the safety/efficacy of expanded in-vitro allogenic mesenchymal stem cell infusion in patients developing a GVHD refractory to the usual therapeutic measures after undergoing an allogeneic hematopoietic stem cell transplant.
Efficacy will be evaluated in terms of GVHD response.
Safety will be evaluated in terms of incidence of adverse events and toxicities related to the administration of MSC.
4 secondary outcomes
Evaluation of infectious complications after MSC infusion.
Analyse the influence of MSC infusion on the posttransplant relapse risk of the base disease.
Study the influence of MSC infusion on DFS and OS.
Determine MSC grafted into the bone marrow (or in other organs).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2007.
- Derived from this study: PubMed 21393326Perez-Simon JA, Lopez-Villar O, Andreu EJ, Rifon J, Muntion S, Diez Campelo M, Sanchez-Guijo FM, Martinez C, Valcarcel D, Canizo CD. Mesenchymal stem cells expanded in vitro with human serum for the treatment of acute and chronic graft-versus-host disease: results of a phase I/II clinical trial. Haematologica. 2011 Jul;96(7):1072-6. doi: 10.3324/haematol.2010.038356. Epub 2011 Mar 10.
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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.
Consuelo del Cañizo, MD study chair
Haematology Service, University Hospital of Salamanca
José A Pérez-Simón, MD principal investigator
Haematology Service, University Hospital of Salamanca
David Varcárcel Ferrerías, MD principal investigator
Haematology Service, Santa Creu i Sant Pau Hospital, Barcelona
4 sites 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 Mesenchymal stem cell (MSC) in people with Graft-vs-Host Disease (GVHD), run by University of Salamanca at 4 sites 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mercedes Comas, CRA (+(034)915545476 ext. 29, mercedes.comas@logitest.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the safety/efficacy of expanded in-vitro allogenic mesenchymal stem cell infusion in patients developing a GVHD refractory to the usual therapeutic measures after undergoing an allogeneic hematopoietic stem cell transplant.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00447460, which also lists 1 linked publication.
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 22 Mar 2007.