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IRCT20171023036966N1 IRCT 2018-01-22 Hematology,Oncology and Stem Cell Transplantation Research Center 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 2018-01-19 anticipated 10 Complete https://irct.ir/trial/27474 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A 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 which is more common. Once lymphedema occurs it may be progressive with different rates and transform the involving limb and this causes pain, movement limitations and makes the limb prone to infections. There are various methods of management but not curative like compression therapies and surgical methods. Condition 2: Hereditary lymphedema is the primary lymphedema in which genetically malfunctional lymphatic vessels rather than obstructions or destructions via cancer, trauma and etc. lead to lymphatic drainage dysfunction and lymph-edema. 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 from bone marrow to peripheral blood. Stem cells will be separated from 200-300 cc of peripheral blood drawn from the cubital vein. Half of the cells will be injected subcutaneously to 80-100 points of unilateral limb and the other half will be frozen for a second injection, 3 weeks later. The circumference and volume of the limb (monthly), the average number of lymphatic vessels (via biopsy), severity of lymphedema (lymphoscintigraphy and transport index), and the quality of life (questionnaire) will be compared before and after the 9 months past the intervention.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Behnam Molavi
North kargar street, Shariati Hospital
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2227 molavibe@sina.tums.ac.ir Department of Vascular Surgery, Shariati Hospital scientific Behnam Molavi
North Kargar street, Shariati Hospital
Tehran Iran (Islamic Republic of) 14111713135 +98 21 8490 2227 molavibe@sina.tums.ac.ir Department of Vascular Surgery, Shariati Hospital Iran (Islamic Republic of) primary lower extremities lymphedema (stage < III) no limit no limit Both 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 I89.0 Q82.0 Lymphedema, not elsewhere classified Hereditary lymphedema Treatment - Other 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 from bone marrow to peripheral blood. Stem cells will be separated from 200-300 cc of peripheral blood drawn from the cubital vein. Half of the cells will be injected subcutaneously to 80-100 points of unilateral limb and the other half will be frozen for a second injection, 3 weeks later. The circumference and volume of the limb (monthly), the average number of lymphatic vessels (via biopsy), severity of lymphedema (lymphoscintigraphy and transport index), and the quality of life (questionnaire) will be compared before and after the 9 months past the intervention. 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. 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. Hematology,Oncology and Stem Cell Transplantation Research Center Approved 2017-07-25 Research Ethics committee of Tehran University of Medical Science Office #605, 6th floor, core building of Tehran University of Medical Science, cross section of Ghods street and Keshavarz blv. Tehran Tehran Iran (Islamic Republic of)