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

Autologous bone marrow derived mononuclear cells (BMMNCs) subfacial transplantation in idiopathic lymphedema patients: clinical trial phase I

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT201611241031N19

Enrollment

Registered

2017-01-27

Start date

2014-02-20

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

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

Interventions

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 numb

Treatment - Other

Eligibility

Sex/Gender

All

Age

10 Years to 35 Years

Inclusion 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

Exclusion criteria:

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHoda Madani

Royan Institute

hoda62_m@yahoo.com+98 21 2356 2458

Outcome results

None listed

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