Treatment with autologous bone marrow mononuclear cells in patients with critical lower limb ischaemia. A pilot study.
OBJECTIVE
Treatment with autologous, bone marrow mononuclear stem cells has shown effects in patients with chronic limb ischaemia in one randomized clinical study. The aim of the study was to test the potential effect of stem cell treatment in a strict defined group of patients with stable critical limb ischaemia (CLI).


METHODS
A prospective, combined-centre pilot study.


METHODS
Eight patients with CLI of the lower extremities, and without any other treatment options.


METHODS
Bone marrow cells were harvested from the patient's iliac crest and, after separation, injected into the calf muscles of the affected leg. Outcome was evaluated by digital subtraction angiography (DSA), visual analogue scale (VAS) and several non-invasive circulatory physiological tests.


RESULTS
There were no complications from the procedures. Two patients were amputated two months after cell injection. Five patients reported pain relief after four months. Five patients could be evaluated at eight months. According to VAS and physiological tests, they were all either stable or showed improvement.


CONCLUSIONS
This method seems to be a safe option for treating patients with CLI. Inclusion of patients took a long time, mainly because many patients with CLI are offered endovascular treatment in our institution. While symptomatic improvement was found in individual patients, larger trials are required to investigate efficacy. This will probably require multi-centre participation.
Wester
T
T
Department of Vascular Surgery, Oslo Vascular Centre, Aker University Hospital, Oslo, Norway.
Jørgensen
J J
JJ
Stranden
E
E
Sandbaek
G
G
Tjønnfjord
G
G
Bay
D
D
Kollerøs
D
D
Kroese
A J
AJ
Brinchmann
J E
JE
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D016026:Bone Marrow Transplantation; D005260:Female; D006801:Humans; D007511:Ischemia / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010865:Pilot Projects; D011446:Prospective Studies; D014182:Transplantation, Autologous; D016896:Treatment Outcome