Abstract
Patients with critical limb ischemia in whom surgical repair is not possible because bad distal vasculature, have an ominous prognosis. This study describes a technique for treatment of patients with critical limb ischemia with implantation of autologous peripheral mobilized hematopoietic cells, with the aim to stimulate angiogenesis.
Twelve patients (9M, 3F), with a median age of 58 years (22–78) with critical limb ischemia were treated by injections of peripheral mobilized blood cells in the gastrocnemius muscle of the affected limb. The inclusion criteria were patients with chronic limb ischemia grade III-IV by Doppler examination, plethismography and angiography, with failure to respond to non-surgical treatment and some with previous surgery, and that were no candidates for surgical revascularization. The patients were treated by G-CSF (Neupogen, Amgen) 5μ /kg weight/d during 5 days. At day fifth and sixth we obtained peripheral mononuclear blood cells by means of a CS-3000 Plus (Baxter) blood cell separator. The unmanipulated cells were injected in the affected limb in 2 ml aliquots into the gastrocnemius muscle. Each product of a single apheresis (volume 50 ml) were injected in a sole limb. Six patients received injections only in one limb. Each patient were evaluated regularly for rest pain, amount of required analgesia, healing of the ulcers, peak walking time and, Doppler, plethismographic and angiographic findings. The mean number of injected CD34+ cells in each limb was 0.77 x 106/kg. There were no secondary effects for the mobilization and injection of cells in the 12 studied patients. Moreover, in 7 patients studied with a median follow-up of 1 year, 5 showed an improvement of all parameters, specially pain at rest, peak walking time and skin throphic lesions. Two patients suffered early amputation of the affected extremity because obstruction of an old by-pass.
Despite the short follow-up and small patient series, this technique is expected to achieve relief of pain and decrease in major amputations in this critical population. However, comparative studies with longer follow-up should be done to confirm the benefits of this technique.
Rationale and Design of Therapeutic Angiogenesis by Cell Transplantation Using Adipose-Derived Regenerative Cells in Patients With Critical Limb Ischemia ― TACT-ADRC Multicenter Trial ―
