Maldonado, G.E., Perez, C.A., Covarrubias, E.E., Cabriales, S.A., Leyva, L.A., Perez, J.C., & Almaguer, D.G. (2011). Autologous stem cells for the treatment of post-mastectomy lymphedema: A pilot study. Cytotherapy, 13(10), 1249–1255.

To establish the efficacy of using autologous stem cells (ASC) for the treatment of lymphedema associated with axillary lymph node dissection, define the possible complications, and compare outcomes with compression sleeve therapy

Twenty patients were randomly assigned to the ASC group or the control group. The ASC group received subcutaneously administered granulocyte-colony-stimulating factor (300 mg per day) for three days prior to the procedure. On procedure day, 100 ml bone marrow was harvested from east posterior iliac crest while the patient was under conscious sedation. The product was centrifuged and, under laminar flow hood, plasma was removed and transferred to sterile test tube. Cells were isolated, and CD34 cells were counted using a flow cytometer. A specimen for microbe and 0.5–1 ml of cell suspension containing 20% albumin and normal saline was administered by intramuscular injection at 30–50 sites of the affected limb, depth of 1 cm, with 25 g needle. Injection range included around the axillary and affected chest wall and part of the upper arm during the first four weeks. Use was discontinued for the following four weeks and then used again for another four weeks. Patients were not allowed to use any other modality of treatment for lymphedema, including manual lymph drainage, exercise drug therapy, or skin products. The control group was given a four-hour practice session on correct use of compression sleeve of 15–20 mmHg.

• The study sample (N = 20) was comprised of female patients with unilateral lymphedema secondary to mastectomy and axillary node dissection.
• Mean age of participants was 50–56 years.
• All patients had not had active cancer in the past five years.
• Patients were excluded from the study if they were older than 75 years, had hypercoagulable states, cardiovascular disease, or bilateral mastectomies.

The study took place at the University Hospital of the School of Medicine of the Universidad Autonoma de Nuevo Leon in Mexico.

The study has clinical applicability for late effects and survivorship.

The pilot study randomly assigned 10 women to either the ASC group or control group.

• Patient's weight was recorded.
• Limb volume measurements were taken of bilateral upper extremities in four areas, calculating mean by summation.
• Arm volume was determined by trunked cone principle were obtained weekly for 12 weeks.
• Patients were evaluated for pain, sensory loss, and arm mobility.

After 12 weeks, the ASC group had decreased pain, improved sensitivity, and improved mobility as compared to the control group. Volume reductions were similar between the two groups, with the control group being more user dependent.

The study does not provide sufficient evidence to determine potential efficacy of stem cell transplant to manage lymphedema.

• The study had a small sample size, with less than 30 participants.
• Sample characteristics present a risk of bias.
• Measurement validity and reliability is questionable.
• The findings are not generalizable.
• The intervention is expensive, impractical, or requires training.

It is important to be aware of studies being conducted. The study has limited practical value in the United States today, but as ASC becomes a more accepted and standard of care, awareness of the decreases in pain and increased sensitivity and mobility may be of benefit.