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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01222039
Other study ID # EudraCT: 2008-004014-27
Secondary ID
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


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
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