Patients with chronic peripheral occlusive arterial disease often are not candidates for conventional revascularization procedures. Preclinical trials have shown that the transplantation of autologous bone marrow cells induces and increases the collateral vessel formation. We analyzed the clinical benefit of combined intraarterial and intramuscular transplantation of adult autologous mononuclear bone marrow stem cells in patients with lower-limb peripheral occlusive arterial disease.
Methods: Patients with severe peripheral occlusive arterial disease and a reduced walking distance (Fontaine stage II or III) were included. Bone marrow was harvested from the hip under local anesthesia and mononuclear cells were transplanted intramuscularly and intraarterially into the ischemic limb after isolation under good manufacturing practice conditions.
Results: After 2 months, pain-free walking distance increased 3.7-fold. Furthermore, the ankle-brachial index was significantly improved at rest and after exercise. Similar improvements could be documented by capillary-venous oxygen saturation and venous occlusion plethysmography. No side effects or complications were detected during transplantation and during time of follow-up.
Conclusions: Combined intraarterial and intramuscular transplantation of autologous mononuclear bone marrow stem cells is a clinically feasible and minimally invasive therapeutic option for patients with severe, chronic peripheral occlusive arterial disease.