Saving Limbs: Autologous Mesenchymal cells for the treatment of patients with critical limb ischemia – an Interim Analysis
The interim analysis of vascular surgery protocol "Autologous Mesenchymal cells for the treatment of patients with critical limb ischemia" is now available and so far, the results are promising.
A total of 6 patients were treated from September 30th, 2009 through November 12th, 2009. Each of these patients was recommended for limb amputation.
The average patient age was 70 years old. Half of the patients treated underwent a previous amputation. Two-thirds suffered from diabetes and only one was not hypertensive. One-third of patients suffered from hyperlipidemia and/or superficial femoral artery stenosis.
Results
4 out 6 patients improved after treatment and did not require amputation. Of the two remaining patients, one underwent amputation and the other, so far, has not yet consented to it despite its recommendation by the treating physician.
Ankle-brachial pressure index (ABPI) increased by an average of 30% in the improved patients. AMPI measures the ratio of blood pressure in the lower legs to blood pressure in the arms. Lower values indicate more severe vascular disease in the legs. On average, patients were categorized with severe arterial disease by ABPI before treatment. After treatment, patients improved to the moderate arterial disease category.
Patients were able to walk 70% further after treatment and they reported that limb pain decreased by an average of 20%.
Both patients who did not improve suffered from superficial femoral artery stenosis.
