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.
OBJECTIVE
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.
Zafarghandi
Mohammad Reza
MR
Department of Vascular Surgery, Tehran University of Medical Sciences, Tehran, Iran.
Ravari
Hassan
H
Aghdami
Nasser
N
Namiri
Mehrnaz
M
Moazzami
Kasra
K
Taghiabadi
Ehsan
E
Fazel
Abdorreza
A
Pournasr
Behshad
B
Farrokhi
Ali
A
Sharifian
Ramezan Ali
RA
Salimi
Javad
J
Moini
Majid
M
Baharvand
Hossein
H
D000328:Adult; D000368:Aged; D055109:Ankle Brachial Index; D016026:Bone Marrow Transplantation; D002452:Cell Count; D018450:Disease Progression; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007273:Injections, Intramuscular; D007511:Ischemia / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D007963:Leukocytes, Mononuclear / Q000187:drug effects / Q000378:metabolism* / Q000473:pathology / Q000637:transplantation; D035002:Lower Extremity / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D020127:Recovery of Function; D014182:Transplantation, Autologous; D016896:Treatment Outcome
D016179:Granulocyte Colony-Stimulating Factor