Use of Stem Cells in Lymphedema Post Mastectomy
Condition: Lymphedema; Breast Cancer
MeSH terms: Lymphedema
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed description: 
      Phase 1:

      The procedure will be as follows:

      10 patients were recruited in the General Surgery or Oncology meeting the inclusion criteria.
      During the study, patients can´t use any other kind of treatment for the lymphedema.

      Visit 1: We explain the procedure by inviting patients to participate after signing informed
      consent. There will be a complete medical history, review of inclusion and exclusion
      criteria, signing a letter of informed consent, be requested general laboratory tests (blood
      count, biochemical profile), tele-ray.

      Visit 2: Initiation colony stimulating factor (Filgrastim SC) to 300 micrograms per day for 3
      consecutive days.

      Visit 3: Conduct a puncture and bone marrow harvesting under local anesthesia of the
      posterior iliac crest with Jamshidi needle to aspirate (approximately 50 - 100ml). The
      product obtained will be centrifuged in a refrigerated centrifuge at 3500 Sigma EK15 ® rpm/15
      minutes to 8 ° C with HES 6% (pentastarch 6g/100ml) to obtain the mononuclear cell layer.
      Once the cells were obtained will be transported to the operating room to manage the patient
      by intramuscular injection of 0.5 to 1 ml in 30 to 50 sites of the affected limb with a depth
      of about one centimeter, using a needle number 25. The administration will take place in the
      operating room under local anesthesia or sedation if necessary.

      Visit 4 and subsequent: clinical evaluation will be conducted each week, especially data
      monitoring of infection in the puncture sites. At week 12 post-cell infusion, the latest
      revision will be made and carried out measurements in both arms to conclude and determine the
      outcome of treatment.

      Phase 2 (Control group):

      Another 10 patients with lymphedema will be included in a 6 week study to compare the most
      common treatment of the lymphedema, the compressed sleeves.

      Visit 1: A complete medical history will be performed. A compression sleeve will be given to
      the patients for their use during the next 2 weeks.

      Visit 2 and 3: On week 2 and 3 of the compression sleeve treatment, the patients will be
      measured in both upper extremities as well as assess the symptoms or not that patients
      present.

      Visit 4 and 5: Patients will stop using the compression sleeve treatment for the next 2 weeks
      measured both upper extremities and interrogate patients about symptoms during this period.

      Visit 6 and 7: The last 2 weeks of the study patients will be asked to restart the compressed
      sleeves treatment and measured both upper extremities and interrogate patients about symptoms
      presented during this stage of the study.
    

Intervention name(s): Autologous transplant; Compressed sleeve treatment
Intervention type(s): Procedure; Other
Intervention description(s): 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
Other intervention name(s): Stem Cells transplant; Compressive sleeve treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphedema; Stem cells; Mastectomy; Breast Cancer