At a glance
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Postoperative Lymphedema Treatment in Upper Extremities Following Axillary Lymphadenectomy by Transplanting Autologous Endothelial Progenitor Cells (EPC)
In Brief
A Phase 2 clinical trial evaluating Autologous transplant and Compressed sleeve treatment for Lymphedema and Breast Cancer. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The post-mastectomy lymphedema is a complication of removal of the breast and nodal plexus that causes accumulation of lymph and subsequent enlargement of the upper limb. It is the most common complication of all attributable to mastectomy with axillary dissection and which occurs in one third of patients who undergo radical mastectomy and radiotherapy post-operation. Currently the treatment of lymphedema of the upper limb is mainly the use of compression stockings, the use of pneumatic compression pumps and physiotherapy. Multiple reports indicate that endothelial progenitor cells (EPC) can differentiate into various cell lines, reproduced and participate in neoangiogenesis. This study was conducted in the General Surgery Service, of the Hospital Universitario "Dr. José Eleuterio González "and proposes the EPC obtained autologous transplantation of bone marrow for the treatment of postoperative lymphedema in upper limb following axillary lymphadenectomy through the stimulation of lymphatic neoangiogenesis. The investigators studied 20 female patients over 18 years after axillary lymphadenectomy. The objective is to develop an innovative and definitive treatment for these patients and to analyze the costs and complications that this treatment may have.
Study Details
Timeline
Interventions
Patients will be stimulated 3 days with Filgrastrim 300 micrograms per day. On the 4th day the autologous transplant of stem cells will be performed.
Week 1-2: With compressed sleeve treatment. Week 3 -4: Without treatment. Week 5 - 6: With compressed sleeve treatment