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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT01222039
First received: October 14, 2010
Last updated: November 6, 2014
Last verified: November 2014

October 14, 2010
November 6, 2014
October 2010
March 2015   (final data collection date for primary outcome measure)
Number of adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01222039 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall survival and disease-free survival. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in lymphocyte subsets and levels of inflammatory and antiinflammatory cytokines in each of the groups. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multicenter Clinical Trial for the Evaluation of Mesenchymal Stem Cells From Adipose Tissue in Patients With Chronic Graft Versus Host Disease.
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.

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Graft Versus Host Disease
  • Chronic and Expanded Graft Versus Host Disease
  • Immune System Diseases
  • Drug: Conventional treatment
    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. 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.

  • Experimental: 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.
    Interventions:
    • Drug: Conventional 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.
  • Experimental: 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.
    Interventions:
    • Drug: Conventional 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.
    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:
    • Drug: Conventional 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
October 2015
March 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01222039
EudraCT: 2008-004014-27
Yes
Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud
Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud
Not Provided
Study Chair: Manuel Jurado Chacón, MD Haematology Department, Hospital Universitario Virgen de las Nieves de Granada. Spain.
Principal Investigator: Ildefonso Espigado, MD Haematology Department, Hospital Universitario Virgen del Rocío de Sevilla, Spain.
Principal Investigator: Carlos Solano Vercet, MD Haematology and Oncology Department. Hospital Clínico Universitario de Valencia, Spain.
Principal Investigator: Sebastián Garzón López., MD Hospital de Jerez de la Frontera, Cádiz. Spain.
Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP