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

NCT01222039 | Completed Phase 1 DMC

• 1 other identifier: EudraCT: 2008-004014-27
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

  24 months

Secondary Outcomes (3)

• 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

Study Arms (2)

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

EXPERIMENTAL

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 low dose: 1x10e6 cells / Kg

EXPERIMENTAL

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.

Interventions

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. 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 high dose: 3x10e6 cells / Kg.; Conventional treatment plus low dose: 1x10e6 cells / Kg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud: lead
• Iniciativa Andaluza en Terapias Avanzadas: collaborator

Study Sites (4)

Hospital de Jerez de la Frontera.

Jerez de la Frontera, Cádiz., 11407, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Granada., 18014., Spain

Location

Hospital Universitario Virgen del Rocío de Sevilla

Seville, Sevilla, 41013, Spain

Location

Hospital Clínico de Valencia

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Graft vs Host Disease; Bronchiolitis Obliterans Syndrome; Immune System Diseases

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Manuel Jurado Chacón, MD

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

  STUDY CHAIR

• 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

ES (4)