Autologous bone marrow derived mononuclear cells transplantation in idiopathic lower limb lymphedema patients

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT201611241031N19
• Date of registration: 2017-01-27
• Prospective Registration: No
• Primary sponsor: Royan Institute
• Public title: Autologous bone marrow derived mononuclear cells transplantation in idiopathic lower limb lymphedema patients
• Scientific title: Autologous bone marrow derived mononuclear cells (BMMNCs) subfacial transplantation in idiopathic lymphedema patients: clinical trial phase I
• Date of first enrolment: 2014-02-20
• Target sample size: 6
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/43
• Study type: interventional
• Study design: Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: not used.
• Phase: 1

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Nasser Aghdami
• Affiliation: Royan Institute

• Name: Hoda Madani
• Affiliation: Royan Institute

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: 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.
Exclusion criteria:

Age minimum: 10 years
Age maximum: 35 years
Gender: Both

Health Condition(s) or Problem(s) studied

Noninfective disorder of lymphatic vessels and lymph nodes, unspecified

Idiopathic lower limb lymphedema.
Noninfective disorder of lymphatic vessels and lymph nodes, unspecified

Intervention(s)

Treatment - Other

Sub-facial transplantation of autologous bone marrow drived mononuclear cell. 0.5-1 cc per point injection. number of point injection is one third of leg length plus 1. cell suspension is half of number of point injections in involved leg

Sub-facial transplantation of autologous bone marrow drived mononuclear cell. 0.5-1 cc per point injection. number of point injection is one third of leg length plus 1. cell suspension is half of number of point injections in involved leg.

Primary Outcome(s)

Safety. Timepoint: Base, 1,2,3,6 and 12 months after transplantation. Method of measurement: Questionnaire.

Secondary Outcome(s)

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.

Source(s) of Monetary Support

Shahid Beheshti University of Medical Science

Royan Institute

Secondary Sponsor(s)

Shahid Beheshti University of Medical Science

Ethics review

Status: Approved
Approval date:
Contact:

Medical Ethic and Law Research Center, Shahid Beheshti University of Medical Sciences