Intraarterial Infusion of Autologous Mesenchymal Stem Cells From Adipose Tissue in Diabetic Patients With Chronic Critical Limb Ischemia
Summary
The Purpose of this trial is to evaluate the safety and feasibility of regenerative therapy with intraarterial infusion of mesenchymal stem cells from adipose tissue, in diabetic patients with chronic critical limb ischemia without revascularization options.
The investigators hypothesize that this approach can be safe and can induce neoangiogenesis in the ischemic limb. During one year follow-up, clinical, angiologic and angiographic measures will be monitored to asses the impact of the cell infusion on the evolution of the ischemic limb.
Study Design
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Diabetes
Intervention
Autologous mesenchymal stem cells from adipose tissue., Autologous mesenchymal stem cells from adipose tissue., Autologous mesenchymal stem cells from adipose tissue.
Location
Hospital Universitario Virgen Macarena.
Sevilla
Spain
41007
Status
Suspended
Source
Fundacion Progreso y Salud, Spain
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01079403
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Mesenchymal Stem Cell Transplantation
Transfer of MESENCHYMAL STEM CELLS between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS).
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.
Stem Cell Transplantation
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.
Nuclear Transfer Techniques
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.
Hematopoietic Stem Cell Transplantation
Transfer of HEMATOPOIETIC STEM CELLS from BONE MARROW or BLOOD between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS). Hematopoietic stem cell transplantation has been used as an alternative to BONE MARROW TRANSPLANTATION in the treatment of a variety of neoplasms.
Clinical Trials
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 t...
Mesenchymal stem cells have capability to differentiate into hepatocyte and will be useful for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cell compared...
The study is to investigate the efficacy and safety of autologous transplantation of adipose-derived mesenchymal stem cells in patients with the sequelae caused by severe brain injury.
Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Type 2 Diabetics
The purpose of this study is to determine whether intravenous administration of autologous adipose-derived stem cells is of benefit in the management of types 2 diabetics.
Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures
Mesenchymal stem cells are found in bone marrow, and have the ability to differentiate into different tissue types. The primary objective of the study is to examine the safety of using suc...
PubMed Articles
Potential for Neural Differentiation of Mesenchymal Stem Cells.
Adult human stem cells have gained progressive interest as a promising source of autologous cells to be used as therapeutic vehicles. Particularly, mesenchymal stem cells (MSCs) represent a great tool...
β-PIX Is Critical for Transplanted Mesenchymal Stromal Cell Migration.
Bone marrow-derived mesenchymal stromal cells (MSCs) have been used successfully as a source of stem cells for treating neurodegenerative diseases. However, for reasons that are not clear, autologous...
ABSTRACT: BACKGROUND: Though sera are essential for Mesenchymal stem cells (MSCs), the effect of heat-inactivation remains unknown. Autologous human serum is recommended for clinical use; however, it...
Adult stem cells are nowadays used for treating several pathologies. A putative stem cell population was found in the adipose tissue of mammals and canine adipose tissue-derived-mesenchymal stem cells...
Tissue-engineered autologous skin is a potential alternative to autograft for burn coverage, but produces poor clinical responses such as unsatisfactory graft intake due to insufficient vascularizatio...
