Bone Marrow Aspirate Concentrate in Critical Limb Ischemia: Results of a Multicenter Randomized Double-Blind Trial

Iafrati, Mark D.; Bandyk, Dennis F.; Benoît, Éric; Geils, George F.; Hallett, John W.; Hingorani, Anil; Lumsden, Alan B.; Pearl, Gregory J.; Peden, Eric K.; Roddy, Sean P.

doi:10.1016/j.jvs.2010.06.135

Cited by 4 publications

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“…The Harvest Trial collected 240 mL of bone marrow that was concentrated and injected into the ischemic extremity, similar to that in this report. 8 These investigators found that freedom from major amputation in patients who presented with tissue loss was 61% in cell therapy patients vs 29% in placebo-treated patients. The RESTORE-CLI trial randomized patients to expanded autologous cell therapy vs placebo in no-option CLI patients 9,10 ; 50 mL of bone marrow was harvested, and cells were then sent to the sponsor, who expanded specific cell lines in a bioreactor for 2 weeks, after which the cells were returned to the site and injected into the limb.…”

Section: Discussionmentioning

confidence: 99%

“…There have been several phase 2 clinical trials that have demonstrated promising outcomes in patients with CLI compared with placebo. 8–10 This was especially true in patients who presented with tissue loss. 3 These trials have used a single set of intramuscular injections of autologous cells obtained from either bone marrow harvest or expanded cell lines after aspiration.…”

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confidence: 99%

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Bone marrow aspirate injection for treatment of critical limb ischemia with comparison to patients undergoing high-risk bypass grafts

Giles

Rzucidlo

Goodney

et al. 2015

Journal of Vascular Surgery

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Objective Bone marrow cell therapy (BMCT) for patients with critical limb ischemia (CLI) is a potential treatment in candidates with poor options for standard revascularization procedures. Whereas clinical trials are ongoing, there are few comparative data to assess its efficacy compared with bypass. Methods Patients with poor revascularization options underwent BMCT between 2011 and 2013. Outcomes were compared with those of a cohort of CLI patients undergoing infrainguinal bypass thought to be at high risk for graft failure (tissue loss, a tibial target, and a previous endovascular treatment or bypass). BMCT patients underwent harvest of bone marrow that was then concentrated and injected intramuscularly into the ischemic limb. Results There were 20 BMCT patients and 35 high-risk bypass patients. All BMCT patients had either rest pain (80%) or tissue loss (80%). The majority (65%) had a prior intervention (bypass, 30%; endovascular, 58%) compared with high-risk bypass patients, all of whom had previous revascularization attempts (bypass, 43% [P = .35]; endovascular, 77% [P = .14]). Mean follow-up was 773 days after BMCT and 972 days after high-risk bypass. All patients tolerated BMCT without issues or complications. A second BMCT treatment was performed in 21% because of clinical deterioration. Wound healing occurred in 75% at 1.5 years, including patients receiving second injections, all of which resolved. Rest pain improved in 87.5% of patients. Pain completely resolved in 58% at 1.5 years. Ankle-brachial index improvement was 0.23 (±0.25). Three BMCT patients went on to amputation. One-year freedom from major amputation or death was 78% for BMCT vs 69% for high-risk bypass (P = .60). Conclusions BMCT is a potential option in CLI patients who are not candidates for bypass or endovascular intervention. Limb salvage is unexpectedly high in this population with few other options.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%