CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Autologous transplant +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01112189
NCT01112189Phase 2Completed

Postoperative Lymphedema Treatment in Upper Extremities Following Axillary Lymphadenectomy by Transplanting Autologous Endothelial Progenitor Cells (EPC)

Hospital Universitario Dr. Jose E. Gonzalez·interventional·Posted Apr 28, 2010·Updated Mar 24, 2011

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 28, 2010
Enrollment StartSep 1, 2009
Primary CompletionAug 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.2 years ago

Interventions

Autologous transplantprocedure

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.

Compressed sleeve treatmentother

Week 1-2: With compressed sleeve treatment. Week 3 -4: Without treatment. Week 5 - 6: With compressed sleeve treatment