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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01222039
First Posted: October 18, 2010
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Iniciativa Andaluza en Terapias Avanzadas
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
  Purpose

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.


Condition Intervention Phase
Graft Versus Host Disease Chronic and Expanded Graft Versus Host Disease Immune System Diseases Other: Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: 24 months ]

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 [ Time Frame: 12 months ]
  • Overall survival and disease-free survival. [ Time Frame: 12 months ]
  • Changes in lymphocyte subsets and levels of inflammatory and antiinflammatory cytokines in each of the groups. [ Time Frame: 12 months ]

Enrollment: 19
Study Start Date: June 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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.
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.


  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01222039


Locations
Spain
Hospital de Jerez de la Frontera.
Jerez de la Frontera, Cádiz., Spain, 11407
Hospital Universitario Virgen de las Nieves
Granada., Spain, 18014.
Hospital Universitario Virgen del Rocío de Sevilla
Sevilla, Spain, 41013
Hospital Clínico de Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Iniciativa Andaluza en Terapias Avanzadas
Investigators
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.
  More Information

Additional Information:
Responsible Party: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT01222039     History of Changes
Other Study ID Numbers: EudraCT: 2008-004014-27
First Submitted: October 14, 2010
First Posted: October 18, 2010
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:
Graft versus host disease
Mesenchymal stem cell
Allogeneic mesenchymal stem cell
Adipose tissue
Allotransplant
Allogenic
Mesenchymal Stem Cells
Immune System Diseases
Chronic
Expanded

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Prednisone
Tacrolimus
Cyclosporins
Cyclosporine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents