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

Graft Versus Host Disease Clinical Trial

— CMM/EICH/2008  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222039
• Other study ID #: EudraCT: 2008-004014-27
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 14, 2010
• Last updated: November 17, 2016
• Start date: June 2010
• Est. completion date: June 2014

Study information

• Verified date: November 2016
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic and Expanded Graft Versus Host Disease
• Graft Versus Host Disease
• Graft vs Host Disease
• Immune System Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de las Nieves	Granada.
Spain	Hospital de Jerez de la Frontera.	Jerez de la Frontera	Cádiz.
Spain	Hospital Universitario Virgen del Rocío de Sevilla	Sevilla
Spain	Hospital Clínico de Valencia	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud	Iniciativa Andaluza en Terapias Avanzadas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events		24 months	Yes
Secondary	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	No
Secondary	Overall survival and disease-free survival.		12 months	No
Secondary	Changes in lymphocyte subsets and levels of inflammatory and antiinflammatory cytokines in each of the groups.		12 months	No

External Links

•   Andalusian Initiative for Advanced Therapies