Chronic and Expanded Graft Versus Host Disease, Graft Versus Host Disease, Immune System Diseases
Conditions
Keywords
Graft versus host disease, Mesenchymal stem cell, Allogeneic mesenchymal stem cell, Adipose tissue, Allotransplant, Allogenic, Mesenchymal Stem Cells, Immune System Diseases, Chronic, Expanded
Brief 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 (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.
Interventions
OTHERConventional 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.
Sponsors
Iniciativa Andaluza en Terapias Avanzadas
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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: 1. They have never received therapy for chronic GVHD. 2. They have de novo or quiescent chronic extended GVHD.
Exclusion criteria
1. Concomitant severe systemic infection. 2. Oncologic or hematological condition relapse. 3. Pregnancy. 4. Estimated life expectancy less than 1 week. 5. Patients who do not give their informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 12 months |
| Overall survival and disease-free survival. | 12 months |
| Changes in lymphocyte subsets and levels of inflammatory and antiinflammatory cytokines in each of the groups. | 12 months |
Countries
Spain
Outcome results
None listed