Graft Versus Host DiseasePhase 1/2CMM/EICH/2008NCT01222039
Multicenter Clinical Trial for the Evaluation of Mesenchymal Stem Cells From Adipose Tissue in Patients With Chronic Graft Versus Host Disease.
A Phase 1/2 study testing Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. in people with Graft Versus Host Disease and Chronic and Expanded Graft Versus Host Disease, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 4 sites in Spain.
Trial summary
The main purpose of this trial is to assess the safety and feasibility of treatment with two-dose infusion of allogeneic mesenchymal stem cells from adipose tissue expanded in vitro in patients undergoing haematopoietic stem cell transplantation (HSCT, who have developed chronic and extensive graft versus host disease… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graft Versus Host Disease, Chronic and Expanded Graft Versus Host Disease, Immune System Diseases
- What is being tested?
- Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 4 sitesSpain
- Study dates
- Jun 2010to Jun 2014
- 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 who develop chronic extensive GVHD as determined by the National Institute of Health Consensus Development Project on Criteria for Clinical Trials in Chronic GVHD (Biol Blood Marrow Transplant 2005; 11: 945-955), and which meet the following criteria:
- They have never received therapy for chronic GVHD.
- They have de novo or quiescent chronic extended GVHD.
Who cannot join
- Concomitant severe systemic infection.
- Oncologic or hematological condition relapse.
- Pregnancy.
- Estimated life expectancy less than 1 week.
- Patients who do not give their informed consent.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Universitario Virgen de las Nieves
Granada, Granada., 18014.
Hospital de Jerez de la Frontera.
Jerez de la Frontera, Cádiz., 11407
Hospital Universitario Virgen del Rocío de Sevilla
Seville, Sevilla, 41013
Hospital Clínico de Valencia
Valencia, Valencia, 46010
About this study
Official title: Multicenter Clinical Trial Phase I/II Randomized, Controlled, for the Evaluation of Safety and Feasibility of Therapy With Two Different Doses of Allogenic Mesenchymal Stem Cells From Adipose Tissue in Patients With Chronic Graft Versus Host Disease.
The main purpose of this trial is to assess the safety and feasibility of treatment with two-dose infusion of allogeneic mesenchymal stem cells from adipose tissue expanded in vitro in patients undergoing haematopoietic stem cell transplantation (HSCT, who have developed chronic and extensive graft versus host disease (GVHD).
Mesenchymal stem cells (MSCs) express low levels of HLA class I molecules, and do not express class II molecules neither CD40, CD80 and CD86, being unable to induce proliferation of allogeneic lymphocytes. In addition, MSCs inhibit lymphocyte proliferation by inhibiting cell division and maintaining these cells in a quiescent state. This supports the hypothesis that MSCs are universal suppressors.
- Conditions
- Graft Versus Host Disease, Chronic and Expanded Graft Versus Host Disease, Immune System Diseases
- Being tested
- Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue.
- Keywords
- Graft versus host disease, Mesenchymal stem cell, Allogeneic mesenchymal stem cell, Adipose tissue, Allotransplant, Allogenic, Mesenchymal Stem Cells, Immune System Diseases, Chronic, Expanded
- Medical subject headings
- Graft vs Host Disease, Bronchiolitis Obliterans Syndrome, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue.Other
Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. Low dose: 1 x10e6 / Kg.
Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin.
Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue.Other
Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. High dose: 3 x10e6/Kg.
Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment plus high dose: 3x10e6 cells / Kg. | Experimental | Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin. Receives: Other: Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. |
| Conventional treatment plus low dose: 1x10e6 cells / Kg | Experimental | Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin. Receives: Other: Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Measured: 24 months
Secondary outcomes (3)
Percentage of patients in each group that may potentially reduce corticosteroids at week 7, 20 and 42, started immunosuppressive treatment and percentage of patients at week 56 have been suspended on full immunosuppressive treatment
Measured: 12 months
Overall survival and disease-free survival.
Measured: 12 months
Changes in lymphocyte subsets and levels of inflammatory and antiinflammatory cytokines in each of the groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Iniciativa Andaluza en Terapias Avanzadas
- Responsible party
- Sponsor
- Investigators
- Manuel Jurado Chacón, MD, Study chair, Haematology Department, Hospital Universitario Virgen de las Nieves de Granada. Spain.Ildefonso Espigado, MD, Principal investigator, Haematology Department, Hospital Universitario Virgen del Rocío de Sevilla, Spain.Carlos Solano Vercet, MD, Principal investigator, Haematology and Oncology Department. Hospital Clínico Universitario de Valencia, Spain.Sebastián Garzón López., MD, Principal investigator, Hospital de Jerez de la Frontera, Cádiz. Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222039
- Sponsor's protocol ID
- EudraCT: 2008-004014-27
- Acronym
- CMM/EICH/2008
- Status last verified
- Nov 2016
- First submitted
- 14 Oct 2010
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Trial Phase I/II Randomized, Controlled, for the Evaluation of Safety and Feasibility of Therapy With Two Different Doses of Allogenic Mesenchymal Stem Cells From Adipose Tissue in Patients With Chronic Graft Versus Host Disease.
- ClinicalTrials.gov ID
- NCT01222039
- Acronym / sponsor ID
- CMM/EICH/2008 / EudraCT: 2008-004014-27
- Conditions
- Graft Versus Host Disease, Chronic and Expanded Graft Versus Host Disease, Immune System Diseases
- Keywords
- Graft versus host disease, Mesenchymal stem cell, Allogeneic mesenchymal stem cell, Adipose tissue, Allotransplant, Allogenic, Mesenchymal Stem Cells, Immune System Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Collaborators
- Iniciativa Andaluza en Terapias Avanzadas
- Study start
- Jun 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Oct 2010 (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 main purpose of this trial is to assess the safety and feasibility of treatment with two-dose infusion of allogeneic mesenchymal stem cells from adipose tissue expanded in vitro in patients undergoing haematopoietic stem cell transplantation (HSCT, who have developed chronic and extensive graft versus host disease (GVHD).
Mesenchymal stem cells (MSCs) express low levels of HLA class I molecules, and do not express class II molecules neither CD40, CD80 and CD86, being unable to induce proliferation of allogeneic lymphocytes. In addition, MSCs inhibit lymphocyte proliferation by inhibiting cell division and maintaining these cells in a quiescent state. This supports the hypothesis that MSCs are universal suppressors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment plus high dose: 3x10e6 cells / Kg. | Experimental | Other: Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue.Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin. |
| Conventional treatment plus low dose: 1x10e6 cells / Kg | Experimental | Other: Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue.Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who develop chronic extensive GVHD as determined by the National Institute of Health Consensus Development Project on Criteria for Clinical Trials in Chronic GVHD (Biol Blood Marrow Transplant 2005; 11: 945-955), and which meet the following criteria:
- They have never received therapy for chronic GVHD.
- They have de novo or quiescent chronic extended GVHD.
Key exclusion criteria (5 listed)
- Concomitant severe systemic infection.
- Oncologic or hematological condition relapse.
- Pregnancy.
- Estimated life expectancy less than 1 week.
- Patients who do not give their informed consent.
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 |
|---|---|---|
| Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue.Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. Low dose: 1 x10e6 / Kg. Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin. | Other | Conventional treatment plus high dose: 3x10e6 cells / Kg., Conventional treatment plus low dose: 1x10e6 cells / Kg |
| Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue.Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. High dose: 3 x10e6/Kg. Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin. | Other | Conventional treatment plus high dose: 3x10e6 cells / Kg., Conventional treatment plus low dose: 1x10e6 cells / Kg |
Primary outcome
Number of adverse events
Time frame: 24 months
3 secondary outcomes
Percentage of patients in each group that may potentially reduce corticosteroids at week 7, 20 and 42, started immunosuppressive treatment and percentage of patients at week 56 have been suspended on full immunosuppressive treatment
Time frame: 12 months
Overall survival and disease-free survival.
Time frame: 12 months
Changes in lymphocyte subsets and levels of inflammatory and antiinflammatory cytokines in each of the groups.
Time frame: 12 months
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 18 Nov 2016.
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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.
Manuel Jurado Chacón, MD study chair
Haematology Department, Hospital Universitario Virgen de las Nieves de Granada. Spain.
Ildefonso Espigado, MD principal investigator
Haematology Department, Hospital Universitario Virgen del Rocío de Sevilla, Spain.
Carlos Solano Vercet, MD principal investigator
Haematology and Oncology Department. Hospital Clínico Universitario de Valencia, Spain.
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 Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. in people with Graft Versus Host Disease and Chronic and Expanded Graft Versus Host Disease, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud 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 3 inclusion and 5 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 18 Nov 2016. 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?
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?
Number of adverse events (time frame: 24 months). 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 18 Nov 2016.