Autologous bone marrow-derived mononuclear cell transplants can reduce diabetic amputations
The researchers noted that surgical or endovascular revascularization options for patients such as those in the study are limited because of poor arterial outflow. Although optimum dose, source and route of administration were outstanding questions, proper BMMNC dose for best results was an issue that the researchers hoped to clarify. They subsequently used a dose ten times smaller than other researchers had used previously in similar studies.
According to the authors, the rationale for their study was that intra-arterial infusions of autologous BMMNCs contain endothelial progenitors that are locally profuse at severely diseased vascular beds in the lower limb. Their hope was that the BMMNCs could promote early and effective development of new vascularization.
Patients were evaluated at three months and twelve months post-transplantation.
"As previously reported, the one-year mortality rate for diabetic patients with PAD - most of which are associated with cardiac complications - has been found to be 20 percent," explained Dr. Soria. "Our study documented significant increases in neovasculogenesis for the majority of our study patients and a decrease in the number of amputations. However, overall PAD mortality for our patients was similar to that generally experienced."
The researchers concluded that BMMNC therapy for lower limb ischemia was a "safe procedure that generates a significant increase in the vascular network in ischemic areas" and promotes "remarkable clinical improvement."
"While this study did not demonstrate a significant effect on mortality, it does suggest an improvement in the quality of life based on limb retention as shown by the significant reduction in the number of amputations", said Amit N. Patel, director of cardiovascular regenerative medicine at the University of Utah and section editor for Cell Transplantation.