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

NCT ID: NCT01222039

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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

Keywords

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Graft versus host disease Mesenchymal stem cell Allogeneic mesenchymal stem cell Adipose tissue Allotransplant Allogenic Mesenchymal Stem Cells Immune System Diseases Chronic Expanded

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional treatment plus high dose: 3x10e6 cells / 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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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.

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

Intervention Type OTHER

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.

Conventional treatment plus low dose: 1x10e6 cells / 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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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.

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

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iniciativa Andaluza en Terapias Avanzadas

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manuel Jurado Chacón, MD

Role: STUDY_CHAIR

Haematology Department, Hospital Universitario Virgen de las Nieves de Granada. Spain.

Ildefonso Espigado, MD

Role: PRINCIPAL_INVESTIGATOR

Haematology Department, Hospital Universitario Virgen del Rocío de Sevilla, Spain.

Carlos Solano Vercet, MD

Role: PRINCIPAL_INVESTIGATOR

Haematology and Oncology Department. Hospital Clínico Universitario de Valencia, Spain.

Sebastián Garzón López., MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Jerez de la Frontera, Cádiz. Spain.

Locations

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Hospital de Jerez de la Frontera.

Jerez de la Frontera, Cádiz., Spain

Site Status

Hospital Universitario Virgen de las Nieves

Granada, Granada., Spain

Site Status

Hospital Universitario Virgen del Rocío de Sevilla

Seville, Sevilla, Spain

Site Status

Hospital Clínico de Valencia

Valencia, Valencia, Spain

Site Status

Countries

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Spain

Other Identifiers

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EudraCT: 2008-004014-27

Identifier Type: -

Identifier Source: org_study_id