Clinical trial NCT01222039: Multicenter Clinical Trial for the Evaluation of Mesenchymal Stem Cells From Adipose Tissue in Patients With Chronic Graft Versus Host Disease.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
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
Chronic
Expanded
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
Collaborators: name: Iniciativa Andaluza en Terapias Avanzadas
First posted: 2010-10-18
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of adverse events
timeFrame: 24 months
Secondary outcomes:
measure: 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
timeFrame: 12 months
measure: Overall survival and disease-free survival.
timeFrame: 12 months
measure: Changes in lymphocyte subsets and levels of inflammatory and antiinflammatory cytokines in each of the groups.
timeFrame: 12 months
Other outcomes:
Locations:
city: Jerez de la Frontera
country: Spain
facility: Hospital de Jerez de la Frontera.
state: Cádiz.
city: Granada.
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío de Sevilla
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
Study officials:
affiliation: Haematology Department, Hospital Universitario Virgen de las Nieves de Granada. Spain.
name: Manuel Jurado Chacón, MD
role: STUDY_CHAIR
affiliation: Haematology Department, Hospital Universitario Virgen del Rocío de Sevilla, Spain.
name: Ildefonso Espigado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haematology and Oncology Department. Hospital Clínico Universitario de Valencia, Spain.
name: Carlos Solano Vercet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Jerez de la Frontera, Cádiz. Spain.
name: Sebastián Garzón López., MD
role: PRINCIPAL_INVESTIGATOR
References: