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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)

17. november 2016 opdateret af: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

Fase

Fase 2
Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Spanien
- - Granada., Spanien, 18014.
    - Hospital Universitario Virgen de las Nieves
  - Sevilla, Spanien, 41013
    - Hospital Universitario Virgen del Rocío de Sevilla
  - Valencia, Spanien, 46010
    - Hospital Clinico de Valencia
- Cádiz.
  - Jerez de la Frontera, Cádiz., Spanien, 11407
    - Hospital de Jerez de la Frontera.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: 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.	Andet: 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. Andet: 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.
Eksperimentel: 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.	Andet: 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. Andet: 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.