Autologous bone marrow derived mononuclear cells transplantation in idiopathic lower limb lymphedema patients
- Conditions
- Idiopathic lower limb lymphedema.Noninfective disorder of lymphatic vessels and lymph nodes, unspecified
- Registration Number
- IRCT201611241031N19
- Lead Sponsor
- Royan Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 6
Age between 10-35 years; Idiopathic lower limb lymphedema; Grade less than III ; Resistant to conventional therapy; Informed consent.
Exclusion criteria:
Heart Failure (EF less than 45%); Renal failure (Cr more than 2) ; Hepatic failure (LFT more than 3 times) ; History of related surgery (lymph node dissection); History of Autoimmune disease; History of trauma or infection; History of pelvic malignancy or treatment for malignancy (Irradiation); Symptoms of sleep apnea; Previous bone marrow transplant; Morbid obesity or Lipedema (BMI = 40); Allergic disorders; Cytotoxic drugs; Drugs induced lymphedema; Congenital vascular malformation; Myxedema; Traveling to tropical countries or suspicion to filariasis; Dependency.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety. Timepoint: Base, 1,2,3,6 and 12 months after transplantation. Method of measurement: Questionnaire.
- Secondary Outcome Measures
Name Time Method Edema volume. Timepoint: base, 1,2,3,6 and 12 months after transplantation. Method of measurement: Water displacement leg volumetry, Circumference measurement.;SF-36 Health Status Questionnaire. Timepoint: 6 and 12 months after transplantation. Method of measurement: Questionnaire.