Multicenter Clinical Trial for the Evaluation of Mesenchymal Stem Cells From Adipose Tissue in Patients With Chronic Graft Versus Host Disease. (CMM/EICH/2008)

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

Status and phase: Completed; Phase 2; Phase 1

Conditions: Graft Versus Host Disease; Immune System Diseases; Chronic and Expanded Graft Versus Host Disease

Treatments: Other: Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue.

Study type: Interventional

Funder types: Other

Identifiers

NCT01222039

EudraCT: 2008-004014-27

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Conventional treatment plus high dose: 3x10e6 cells / Kg.

Experimental group

Description:

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.

Treatment:

Other: 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.

Conventional treatment plus low dose: 1x10e6 cells / Kg

Experimental group

Description:

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.

Treatment:

Other: 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.