Multicenter Clinical Trial for the Evaluation of Mesenchymal Stem Cells From Adipose Tissue in Patients With Chronic Graft Versus Host Disease.

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.

Conditions

• Graft Versus Host Disease
• Chronic and Expanded Graft Versus Host Disease
• Immune System Diseases

Interventions

OTHER

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 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.

Sponsors & Collaborators

• Iniciativa Andaluza en Terapias Avanzadas

  collaborator OTHER

• Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

  lead OTHER

Principal Investigators

• Manuel Jurado Chacón, MD · Haematology Department, Hospital Universitario Virgen de las Nieves de Granada. Spain.

• Ildefonso Espigado, MD · Haematology Department, Hospital Universitario Virgen del Rocío de Sevilla, Spain.

• Carlos Solano Vercet, MD · Haematology and Oncology Department. Hospital Clínico Universitario de Valencia, Spain.

• Sebastián Garzón López., MD · Hospital de Jerez de la Frontera, Cádiz. Spain.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2014-06-30

Completion

2014-06-30

Countries

• Spain

Study Locations