Safety and efficacy of granulocyte-colony-stimulating factor administration following autologous intramuscular implantation of bone marrow mononuclear cells: a randomized controlled trial in patients with advanced lower limb ischemia.

Abstract:

BACKGROUND AIMS:The aim was to investigate the therapeutic effect of granulocyte-colony-stimulating factor (G-CSF) administration following implantation of autologous bone marrow mononuclear cells (BM MNC) for patients with lower limb ischemia. METHODS:The design was a randomized controlled trial. Fifteen patients with severe chronic limb ischemia were treated with autologous BM MNC [without G-CSF (MNC-G-CSF) or combined with G-CSF administration for 5 days following transplantation (MNC+G-CSF)]. RESULTS:All clinical parameters, including ankle brachial index, visual analog scale and pain-free walking distance, showed a mean improvement from baseline, which was measured at 4 and 24 weeks after transplantation in both groups. However, in three (20%) patients, the clinical course did not improve and limb salvage was not achieved. No significant difference was observed among the patients treated in the MNC-G-CSF and MNC+G-CSF groups. No severe adverse reactions were reported during the study period. No relationship was observed between both the numbers of viable MNC or CD34+ cells and the clinical outcome. CONCLUSIONS:Autologous transplantation of BM MNC into ischemic lower limbs is safe, feasible and efficient for patients with severe peripheral artery disease. However, the administration of G-CSF following cell transplantation does not improve the effect of BM MNC implantation and therefore would not have any beneficial value in clinical applications of such cases.

journal_name

Cytotherapy

journal_title

Cytotherapy

authors

Zafarghandi MR,Ravari H,Aghdami N,Namiri M,Moazzami K,Taghiabadi E,Fazel A,Pournasr B,Farrokhi A,Sharifian RA,Salimi J,Moini M,Baharvand H

doi

10.3109/14653240903518163

subject

Has Abstract

pub_date

2010-10-01 00:00:00

pages

783-91

issue

6

eissn

1465-3249

issn

1477-2566

pii

S1465-3249(10)70444-8

journal_volume

12

pub_type

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