Clinical trial · Interventional
Use of Stem Cells in Lymphedema Post Mastectomy
Postoperative Lymphedema Treatment in Upper Extremities Following Axillary Lymphadenectomy by Transplanting Autologous Endothelial Progenitor Cells (EPC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous transplant | Procedure | — | UNRESOLVED |
| Compressed sleeve treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patients with stem cells
- description
- Patients that receive the stem cells treatment
- interventionNames
- Procedure: Autologous transplant
- type
- ACTIVE_COMPARATOR
- label
- Compressed sleeve treatment
- description
- Patients that will receive the compressed sleeve treatment
- interventionNames
- Other: Compressed sleeve treatment
Primary outcomes (1)
- measure
- 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.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDThomas-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
- BACKGROUNDLevine 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
- BACKGROUNDBumpers 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
- BACKGROUNDKim 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
- DERIVEDMaldonado 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