Use of Stem Cells in Lymphedema Post Mastectomy (SCL)

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT01112189
First received: April 20, 2010
Last updated: March 23, 2011
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Lymphedema
Breast Cancer
Procedure: Autologous transplant
Other: Compressed sleeve treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Postoperative Lymphedema Treatment in Upper Extremities Following Axillary Lymphadenectomy by Transplanting Autologous Endothelial Progenitor Cells (EPC)

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    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:
  • Participants with Adverse Events as a Measure of Safety and Tolerability. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with stem cells
Patients that receive the stem cells treatment
Procedure: Autologous transplant
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.
Other Name: Stem Cells transplant
Active Comparator: Compressed sleeve treatment
Patients that will receive the compressed sleeve treatment
Other: Compressed sleeve treatment

Week 1-2: With compressed sleeve treatment.

Week 3 -4: Without treatment.

Week 5 - 6: With compressed sleeve treatment

Other Name: Compressive sleeve treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with postsurgical lymphedema in upper extremities following axillary lymphadenectomy.
  • Female gender.
  • Age over 18 years.
  • Patients who wish to participate in the study.
  • Informed consent signed.

Exclusion criteria:

  • Patients with hypercoagulable states.
  • Patients with a history of obstructive vascular disease in the brain, kidneys or heart.
  • Patients with congestive heart failure (ejection fraction less than 30%)
  • Active infectious process, serious, anywhere in the body.
  • Patients over 75 years of age.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112189

Locations
Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico, 64810
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
Principal Investigator: Gerardo E. Muñoz Maldonado, MD Hospital Universitario Dr Jose Eleuterio Gonzalez
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. med Gerardo Enrique Muñoz Maldonado, Hospital Universitario "Dr. José Eleuterio González"
ClinicalTrials.gov Identifier: NCT01112189     History of Changes
Other Study ID Numbers: CG08-005
Study First Received: April 20, 2010
Last Updated: March 23, 2011
Health Authority: Mexico: Ethics Committee

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
Lymphedema
Stem cells
Mastectomy
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014