Bone Marrow Aspirate Concentrate (BMAC) for the treatment of 27 patients with peripheral arterial disease grade III & IV. A pilot non-randomized study

Abstract

Background & Aim Peripheral arterial diseases (PAD), as a member of arteriosclerosis, mostly occur in lower extremity arteries. The morbidity of PAD generally ranged from 3 to 10% and can reach above 15% and it upregulates with aging. Autologous bone marrow aspirate concentrated cells (BMAC) have been shown to be safe and effective for treatment of patients with PAD. Angiogenesis can also be induced by growth factors synthesized by them. Methods, Results & Conclusion A descriptive, observational and pilot study, non randomize, a total of 27 patients with critical non-revascularized limb isquemia grade III and IV (Fontaine) were enrolled and studied between 2015 and 2019. Risk factors like diabetes, hypertension, nicotine, dislipemia were compared. A total up to 120 ml of BM cells was aspirated from left illiac crest, into 0.1 ml heparin treated in 20 ml syringes and collected in Harvest Device Technology. Centrifugation was done under protocol Harvest Tech. 20 ml of the bottom centrifugation with total nucleated cells were obtained. The medium dose obtained in all patients was 897.000.000 of TNC's counted by Neubauer chamber with trypan blue (98% of viability). 40-point sites in the leg was injected by BMAC via intramuscular needle 22G from the last site where the superficial femoral artery is permeable. The procedure starts in the proximal part by echo guided images, in order to locate the area of artery that is still permeable, then injections of 1ml with 22G needle are made in an interval of 1 cm. After one year of follow up of 27 patients (100%), 14,8% (4) have amputation of the critical limb affected, 14,8% have strong relationship with cigarettes (74.1%) and have a Fontaine score 4. The 85,2 % of the patients have a strong improvement in their quality of life, ABI and conserve their leg. An angiography was done pre/post (3 months) intramuscular injection were arteries and neoangiogenic blood vessels could be shown by images. The following conclusions were drawn: 1) intramuscular implantation of BMAC in patients with severe PAD is an effective approach that is associated with short-term induction of neovascularization; 2) clinical improvement in the lower limb, which included increased ABI values, increased leg temperature, and other local signs that are indirect indicators of collateral vessel formation; 3) BMAC is a safe procedure, with no adverse events resulting from cell therapy as a point of care-same day procedure in patients with Fontaine Score III-IV.