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

Phase 1

Completed

• Conditions: Chronic and Expanded Graft Versus Host Disease; Immune System Diseases; Graft Versus Host Disease
• Interventions: Other: Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue.

• Registration Number: NCT01222039
• Lead Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of adverse events	24 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada., Spain

Hospital de Jerez de la Frontera.; 🇪🇸 Jerez de la Frontera, Cádiz., Spain

Hospital Universitario Virgen del Rocío de Sevilla; 🇪🇸 Sevilla, Spain

Hospital Clínico de Valencia; 🇪🇸 Valencia, Spain