Use of Stem Cells in Lymphedema Post Mastectomy

Phase 1

Completed

• Conditions: Lymphedema; Breast Cancer
• Interventions: Procedure: Autologous transplant; Other: Compressed sleeve treatment

• Registration Number: NCT01112189
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Brief 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.

Study Timeline

• Study Start: 2009-09
• Status Verified: 2010-02
• Study First Submitted: 2010-04-20
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-28
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Last Update Submitted: 2011-03-23
• Last Update Posted: 2011-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with stem cells	Autologous transplant	Patients that receive the stem cells treatment
Compressed sleeve treatment	Compressed sleeve treatment	Patients that will receive the compressed sleeve treatment

Primary Outcome Measures

Name	Time	Method
Determine if the stem cells are effective in patients with lymphedema with the decreased of the volume of the affected limb and improvement of the symptomatology.	3 months	Patients will be measured in 4 different areas of both arms with a tape measure, before the transplant and weekly after the transplant for 3 months.; Measure 1: 10 cm over the epicondyle. Measure 2: 5 cm over the the epicondyle. Measure 3: 5 cm under the the epicondyle. Measure 4: 15 cm under the the epicondyle Also a questionnaire of the most common symptoms will be given to the patients to mark their own symptoms before the transplant and 3 months after the transplant.

Secondary Outcome Measures

Name	Time	Method
Participants with Adverse Events as a Measure of Safety and Tolerability.	3 months

Trial Locations

Locations (1)

Hospital Universitario Dr Jose Eleuterio Gonzalez; 🇲🇽 Monterrey, Nuevo León, Mexico