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NCT Number: NCT01222039

Multicenter Clinical Trial for the Evaluation of 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.

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Key information

Conditions

Graft Versus Host Disease Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic and Expanded Graft Versus Host Disease Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital de Jerez de la Frontera., Jerez de la Frontera, Cádiz., Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of adverse events

    Time frame: 24 months

Secondary outcomes

  1. 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

  2. Overall survival and disease-free survival.

    Time frame: 12 months

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Iniciativa Andaluza en Terapias Avanzadas

Registry information

Official study 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.

Acronym: CMM/EICH/2008

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 18, 2010
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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