Use of Stem Cells in Lymphedema Post Mastectomy

NCT01112189 | Completed Phase 1 DMC

• 1 other identifier: CG08-005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema; Breast Cancer

Keywords

Lymphedema; Stem cells; Mastectomy; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  3 months

Secondary Outcomes (1)

• Participants with Adverse Events as a Measure of Safety and Tolerability.

  3 months

Study Arms (2)

Patients with stem cells

EXPERIMENTAL

Patients that receive the stem cells treatment

Procedure: Autologous transplant

Compressed sleeve treatment

ACTIVE COMPARATOR

Patients that will receive the compressed sleeve treatment

Other: Compressed sleeve treatment

Interventions

Autologous transplant PROCEDURE

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.

Also known as: Stem Cells transplant

Patients with stem cells

Compressed sleeve treatment OTHER

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

Also known as: Compressive sleeve treatment

Compressed sleeve treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, Nuevo León, 64810, Mexico

Location

Related Publications (5)

• Thomas-MacLean R, Miedema B, Tatemichi SR. Breast cancer-related lymphedema: women's experiences with an underestimated condition. Can Fam Physician. 2005 Feb;51(2):246-7.

  PMID: 16926934 BACKGROUND

• Levine M; Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. Clinical practice guidelines for the care and treatment of breast cancer: adjuvant systemic therapy for node-positive breast cancer (summary of the 2001 update). The Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. CMAJ. 2001 Mar 6;164(5):644-6. No abstract available.

  PMID: 11258212 BACKGROUND

• Bumpers HL, Best IM, Norman D, Weaver WL. Debilitating lymphedema of the upper extremity after treatment of breast cancer. Am J Clin Oncol. 2002 Aug;25(4):365-7. doi: 10.1097/00000421-200208000-00009.

  PMID: 12151966 BACKGROUND

• Kim H, Dumont DJ. Molecular mechanisms in lymphangiogenesis: model systems and implications in human disease. Clin Genet. 2003 Oct;64(4):282-92. doi: 10.1034/j.1399-0004.2003.00152.x.

  PMID: 12974730 BACKGROUND

• Maldonado GE, Perez CA, Covarrubias EE, Cabriales SA, Leyva LA, Perez JC, Almaguer DG. Autologous stem cells for the treatment of post-mastectomy lymphedema: a pilot study. Cytotherapy. 2011 Nov;13(10):1249-55. doi: 10.3109/14653249.2011.594791.

  PMID: 21999374 DERIVED

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Gerardo E. Muñoz Maldonado, MD

  Hospital Universitario Dr Jose Eleuterio Gonzalez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 28, 2010
• Study Start: September 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 24, 2011

Record last verified: 2010-02

Locations

ME (1)