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Treatment of Fistulous Crohn's Disease by Implant of Autologous Mesenchymal Stem Cells Derived From Adipose Tissue

2014-08-27 03:12:24 | BioPortfolio

Summary

Primary outcome measure:

Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Crohn's disease patients, collecting the reactions and adverse events occurred during the study.

Secondary outcome measures:

1. Evaluating the Adipose-derived mesenchymal stem cells therapeutic effect, in particular:

- Fistulas healing efficiency

- Changes in quality of life in patients treated

- Changes of systemic Crohn's disease after implant

- Relapse rate monitored among patients who achieved Adipose-derived mesenchymal Stem Cells treatment success.

2. Achieving the biological characterization of the cell product used and its correlation with the therapeutic effect measured with:

- Phenotype study

- Suppressor capacity study.

- Citoquines production analysis

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Crohn Disease

Intervention

Autologous mesenchymal stem cells

Location

Clínica Universitaria de Navarra
Pamplona
Spain
31008

Status

Recruiting

Source

Instituto Cientifico y Tecnologico de Navarra, Universidad de Navarra

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:24-0400

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Medical and Biotech [MESH] Definitions

Transfer of MESENCHYMAL STEM CELLS between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS).

Bone-marrow-derived, non-hematopoietic cells that support HEMATOPOETIC STEM CELLS. They have also been isolated from other organs and tissues such as UMBILICAL CORD BLOOD, umbilical vein subendothelium, and WHARTON JELLY. These cells are considered to be a source of multipotent stem cells because they include subpopulations of mesenchymal stem cells.

Cells that can develop into distinct mesenchymal tissue such as BONE; TENDONS; MUSCLES; ADIPOSE TISSUE; CARTILAGE; NERVE TISSUE; and BLOOD and BLOOD VESSELS.

The transfer of STEM CELLS from one individual to another within the same species (TRANSPLANTATION, HOMOLOGOUS) or between species (XENOTRANSPLANTATION), or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS). The source and location of the stem cells determines their potency or pluripotency to differentiate into various cell types.

Methods of implanting a CELL NUCLEUS from a donor cell into an enucleated acceptor cell. Often the nucleus of a somatic cell is transferred into a recipient OVUM or stem cell (STEM CELLS) with the nucleus removed. This technology may provide means to generate autologous diploid pluripotent cell for therapeutic cloning, and a model for studying NUCLEAR REPROGRAMMING in embryonic stem cells. Nuclear transfer was first accomplished with frog eggs (RANA PIPIENS) and reported in 1952.

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