Status:
COMPLETED
Multicenter Clinical Trial for the Evaluation of Mesenchymal Stem Cells From Adipose Tissue in Patients With Chronic Graft Versus Host Disease.
Lead Sponsor:
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Collaborating Sponsors:
Iniciativa Andaluza en Terapias Avanzadas
Conditions:
Graft Versus Host Disease
Chronic and Expanded Graft Versus Host Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 underg...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01222039
Start Date
June 1 2010
End Date
June 1 2014
Last Update
November 18 2016
Active Locations (4)
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1
Hospital de Jerez de la Frontera.
Jerez de la Frontera, Cádiz., Spain, 11407
2
Hospital Universitario Virgen de las Nieves
Granada, Granada., Spain, 18014.
3
Hospital Universitario Virgen del Rocío de Sevilla
Seville, Sevilla, Spain, 41013
4
Hospital Clínico de Valencia
Valencia, Valencia, Spain, 46010