Local Injection of Autologous Bone Marrow-Derived Mononuclear Cells as a Treatment Method for Idiopathic Lower LimbLymphoedema: Clinical Trial Phase I

Background and Aim: lymphedema is lymphatic system drainingdysfunction. Currently, conventional treatments for primary lower limblymphoedema (LLL) are preserving treatment and are not curative. Stemcells have been considered in the treatment of lymphatic drainage disorderover the last few years, and some success in vivo studies have beenpublished. Therefore, due to the inadequacy of studies and evidence inthis field, this study aimed to investigate the effect of subfascial injectionof autologous bone marrow-derived mononuclear cells in patients withidiopathic LLL by Royan Institute and Shohada-e Tajrish Hospital.Methods: This open-labeled, non-randomized clinical trial phase Iwhich has registered on IRCT website with IRCT201611241031N19code, enrolled 6 idiopathic LLL patients aged 10 to 35 years whoreferred to Shahdai Tajrish Hospital s vascular surgery clinic. After theeligible criteria assessment, informed consent was obtained. Patientswith secondary causes of Lymphoedema are excluded. All patientsunderwent bone marrow aspiration equals 2 cc/kg. Bone marrow-derivedmononuclear cells (MNCs) isolation was done under GMP standards.The cell suspension was transferred to the hospital on the same day andtransplanted sub-facially in 3 cm distance points of the involved leg. Thesepatients are followed at 1, 2, 3, 6 and 12 months after transplantationby safety assessment, water displacement leg volumetry, circumferencemeasurement, weight, and SF-36 Health Status Questionnaire.Results: Totally, 6 patients, 4 females and 2 males with grade II and III ofdisease were enrolled. Two patients had bilateral involvement, one rightleg, and 3 left legs. At least 11 years and at most 32 years. The mean ageof non-congenital patients was 22.25 ± 4.50 years. The primary outcomewas safety evaluation. No complications were observed after injectionduring follow up time. Besides, data showed some evidence of symptomrelief, volume reduction and quality of life improvement in patients.Conclusion: In a 12-month period, local transplantation of the autologousMNCs-derived bone marrow had no complications for idiopathic LLLpatients. Also, there is little evidence of the therapeutic effectivenessof these cells in which needs to be reviewed and confirmed by furtherstudies.

کلیدواژه ها:

Idiopathic lymphoedema ، Autologous bone marrow-derived mononuclear cells ، Cell therapy ، Stem cell