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Using the Stem Cells to Cure Lower Limb Lymphedema

Investigating the Effects of Peripheral Blood Stem Cells Injection in Treatment of Primary Lower Extremity Lymphedema

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20171023036966N1
Enrollment
10
Registered
2018-01-22
Start date
2018-01-19
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Lymphedema is the accumulation of lymphatic fluid in the extravascular space resulted from dysfunction of lymphatic drainage because of mostly structural damage in lymphatic vessels. Various etiology of lymphedema is consist of primary and genetic malfunctions presenting the disease congenitally, over the first year after birth, up to 35 years or after this age and cancers and their treatment methods, traumas and other causes for example filariasis can cause the secondary lymphedema

Interventions

Intervention group: a single group of 10 patients with primary lower extremity(ies) lymphedema, with no exclusion criteria, will receive 10mcg/kg/day of G-CSF for 3-5 days to recruit more stem cells f
Treatment - Other

Sponsors

Hematology,Oncology and Stem Cell Transplantation Research Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: primary lower extremities lymphedema (stage < III)

Exclusion criteria

Exclusion criteria: Uncontrolled hypertension Diabetes Sever heart failure (EF<30 %) Coronary arterial disease Chronic renal disease History of any malignancies over the last 10 years History of chemo/radiotherapy in the last 10 years Organ transplantations in the last 10 years Active infection of the lower extremities

Design outcomes

Primary

MeasureTime frame
Circumference of the lymphedematous lower extremity in specific distances of the limb length. Timepoint: Before intervention and then monthly up to 9 months. Method of measurement: Tape measuring.;Volume of the Circumference of the lymphedematous lower extremity. Timepoint: Before intervention and then monthly up to 9 months. Method of measurement: Volume of truncated cone formula.

Secondary

MeasureTime frame
Quality of life. Timepoint: Before intervention and end of the follow up time (9 months after intervention). Method of measurement: WHO QOL questionnaire (SF 26).;Lymphoscintigraphic Transport Index (TI). Timepoint: Before intervention and end of the follow up time (9 months after intervention). Method of measurement: Report of lymphoscintigraphy by the expert nuclear medicine specialist.;Average number of subcutaneous lymphatic vessels of the lower extremities. Timepoint: Before intervention and end of the follow up time (9 months after intervention). Method of measurement: Histopathologic investigation and immunohistochemistery (IHC) staining by the expert pathologist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehnam Molavi

Department of Vascular Surgery, Shariati Hospital

molavibe@sina.tums.ac.ir+98 21 8490 2227

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026