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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. (CMM/EICH/2008)

Primary Purpose

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

Status

Completed

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Graft Versus Host Disease focused on measuring Graft versus host disease, Mesenchymal stem cell, Allogeneic mesenchymal stem cell, Adipose tissue, Allotransplant, Allogenic, Mesenchymal Stem Cells, Immune System Diseases, Chronic, Expanded

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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:

They have never received therapy for chronic GVHD.
They have de novo or quiescent chronic extended GVHD.

Exclusion Criteria:

Concomitant severe systemic infection.
Oncologic or hematological condition relapse.
Pregnancy.
Estimated life expectancy less than 1 week.
Patients who do not give their informed consent.

Sites / Locations

Hospital de Jerez de la Frontera.
Hospital Universitario Virgen de las Nieves
Hospital Universitario Virgen del Rocío de Sevilla
Hospital Clínico de Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

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

Conventional treatment plus low dose: 1x10e6 cells / Kg

Arm 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.

Outcomes

Primary Outcome Measures

Number of adverse events

Secondary Outcome Measures

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

Overall survival and disease-free survival.

Changes in lymphocyte subsets and levels of inflammatory and antiinflammatory cytokines in each of the groups.

Full Information

NCT ID

NCT01222039

First Posted

October 14, 2010

Last Updated

November 17, 2016

Sponsor

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

Collaborators

Iniciativa Andaluza en Terapias Avanzadas

1. Study Identification

Unique Protocol Identification Number

NCT01222039

Brief Title

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

Acronym

CMM/EICH/2008

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

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

Collaborators

Iniciativa Andaluza en Terapias Avanzadas

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm 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.

Arm Title

Conventional treatment plus low dose: 1x10e6 cells / Kg

Arm Type

Experimental

Arm 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.

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of adverse events

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Time Frame

12 months

Title

Overall survival and disease-free survival.

Time Frame

12 months

Title

Changes in lymphocyte subsets and levels of inflammatory and antiinflammatory cytokines in each of the groups.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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: They have never received therapy for chronic GVHD. They have de novo or quiescent chronic extended GVHD. Exclusion Criteria: Concomitant severe systemic infection. Oncologic or hematological condition relapse. Pregnancy. Estimated life expectancy less than 1 week. Patients who do not give their informed consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manuel Jurado Chacón, MD

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ildefonso Espigado, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Carlos Solano Vercet, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sebastián Garzón López., MD

Organizational Affiliation

Hospital de Jerez de la Frontera, Cádiz. Spain.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Jerez de la Frontera.

City

Jerez de la Frontera

State/Province

Cádiz.

ZIP/Postal Code

11407

Country

Spain

Facility Name

Hospital Universitario Virgen de las Nieves

City

Granada.

ZIP/Postal Code

18014.

Country

Spain

Facility Name

Hospital Universitario Virgen del Rocío de Sevilla

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Hospital Clínico de Valencia

City

Valencia

ZIP/Postal Code

46010

Country

Spain

12. IPD Sharing Statement

Links:

URL

http://www.juntadeandalucia.es/terapiasavanzadas/

Description

Andalusian Initiative for Advanced Therapies

Learn more about this trial

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

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