Adipose-derived stromal vascular fraction (SVF) cells for the treatment of non-reconstructable peripheral vascular disease in patients with critical limb ischemia: A 6-year follow-up showing durable effects

We previously reported 18-month results post-injection of adipose-derived stromal vascular fraction (SVF) cells in 10 patients with end-stage peripheral vascular disease (PVD) in critical limb ischemia (CLI) and candidates for amputation, secondary to long-standing diabetes and/or arteriosclerotic d...

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Main Authors: Michael H. Carstens, Maria Zelaya, Dorian Calero, Carlos Rivera, Diego Correa
Format: Article
Language:English
Published: Elsevier 2020-12-01
Series:Stem Cell Research
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S187350612030372X
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author Michael H. Carstens
Maria Zelaya
Dorian Calero
Carlos Rivera
Diego Correa
author_facet Michael H. Carstens
Maria Zelaya
Dorian Calero
Carlos Rivera
Diego Correa
author_sort Michael H. Carstens
collection DOAJ
description We previously reported 18-month results post-injection of adipose-derived stromal vascular fraction (SVF) cells in 10 patients with end-stage peripheral vascular disease (PVD) in critical limb ischemia (CLI) and candidates for amputation, secondary to long-standing diabetes and/or arteriosclerotic disease. We documented positive clinical outcomes demonstrating pain relief as a change in the Rutherford score, improvement of ankle-brachial ratios (ABI), complete healing of 6 critical-size ulcers and evidence of neovascularization to the foot by MRI-based angiography. We now report persistency of the effect 6 years post-procedure in five patients and 4 years post-procedure in four additional patients who remained asymptomatic until death due to cardiac causes (patient 3) and lost from the study (patient 1). The 10th patient died early in the study. All treated extremities remain asymptomatic with increased ambulation, no recurrence of ulceration, and doppler color flow imaging at various vascular levels of the extremity demonstrating persistent blood flow and the presence of pulses doppler waveforms in the treated foot. Despite the extent of the disease, the contralateral extremities have not worsened significantly and no new ulcerations have appeared in any of the patients. Collectively, these data demonstrate that SVF injections have a durable long-term benefit forestalling further progression of the disease.
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spelling doaj.art-d5a0085596aa4c7eac9fe151a12fd0202022-12-21T22:03:00ZengElsevierStem Cell Research1873-50612020-12-0149102071Adipose-derived stromal vascular fraction (SVF) cells for the treatment of non-reconstructable peripheral vascular disease in patients with critical limb ischemia: A 6-year follow-up showing durable effectsMichael H. Carstens0Maria Zelaya1Dorian Calero2Carlos Rivera3Diego Correa4Wake Forest Institute for Regenerative Medicine, Wake Forest University, Winston-Salem, NC, USA; Department of Surgery, Universidad Nacional Autónoma de Nicaragua, León, Nicaragua; Corresponding authors at: Wake Forest University Institute of Regenerative Medicine, 391 Technology Way, Winston-Salem, NC 27101, USA (M. Carstens). Department of Orthopedics, UHealth Sports Medicine Institute, and Diabetes Research Institute & Cell Transplant Center, University of Miami Miller School of Medicine, Miami, FL 33136, USA (D. Correa).Department of Radiology, Universidad Nacional Autónoma de Nicaragua, León, NicaraguaDepartment of Radiology, Universidad Nacional Autónoma de Nicaragua, León, NicaraguaDepartment of Radiology, Universidad Nacional Autónoma de Nicaragua, Matagalpa, NicaraguaDepartment of Orthopedics, UHealth Sports Medicine Institute, University of Miami, Miller School of Medicine, Miami, FL, USA; Diabetes Research Institute and Cell Transplant Center, University of Miami, Miller School of Medicine, Miami, FL, USA; Corresponding authors at: Wake Forest University Institute of Regenerative Medicine, 391 Technology Way, Winston-Salem, NC 27101, USA (M. Carstens). Department of Orthopedics, UHealth Sports Medicine Institute, and Diabetes Research Institute & Cell Transplant Center, University of Miami Miller School of Medicine, Miami, FL 33136, USA (D. Correa).We previously reported 18-month results post-injection of adipose-derived stromal vascular fraction (SVF) cells in 10 patients with end-stage peripheral vascular disease (PVD) in critical limb ischemia (CLI) and candidates for amputation, secondary to long-standing diabetes and/or arteriosclerotic disease. We documented positive clinical outcomes demonstrating pain relief as a change in the Rutherford score, improvement of ankle-brachial ratios (ABI), complete healing of 6 critical-size ulcers and evidence of neovascularization to the foot by MRI-based angiography. We now report persistency of the effect 6 years post-procedure in five patients and 4 years post-procedure in four additional patients who remained asymptomatic until death due to cardiac causes (patient 3) and lost from the study (patient 1). The 10th patient died early in the study. All treated extremities remain asymptomatic with increased ambulation, no recurrence of ulceration, and doppler color flow imaging at various vascular levels of the extremity demonstrating persistent blood flow and the presence of pulses doppler waveforms in the treated foot. Despite the extent of the disease, the contralateral extremities have not worsened significantly and no new ulcerations have appeared in any of the patients. Collectively, these data demonstrate that SVF injections have a durable long-term benefit forestalling further progression of the disease.http://www.sciencedirect.com/science/article/pii/S187350612030372XPeripheral vascular diseaseNeovascularizationStromal vascular fractionCell therapyArteriosclerosisDiabetes
spellingShingle Michael H. Carstens
Maria Zelaya
Dorian Calero
Carlos Rivera
Diego Correa
Adipose-derived stromal vascular fraction (SVF) cells for the treatment of non-reconstructable peripheral vascular disease in patients with critical limb ischemia: A 6-year follow-up showing durable effects
Stem Cell Research
Peripheral vascular disease
Neovascularization
Stromal vascular fraction
Cell therapy
Arteriosclerosis
Diabetes
title Adipose-derived stromal vascular fraction (SVF) cells for the treatment of non-reconstructable peripheral vascular disease in patients with critical limb ischemia: A 6-year follow-up showing durable effects
title_full Adipose-derived stromal vascular fraction (SVF) cells for the treatment of non-reconstructable peripheral vascular disease in patients with critical limb ischemia: A 6-year follow-up showing durable effects
title_fullStr Adipose-derived stromal vascular fraction (SVF) cells for the treatment of non-reconstructable peripheral vascular disease in patients with critical limb ischemia: A 6-year follow-up showing durable effects
title_full_unstemmed Adipose-derived stromal vascular fraction (SVF) cells for the treatment of non-reconstructable peripheral vascular disease in patients with critical limb ischemia: A 6-year follow-up showing durable effects
title_short Adipose-derived stromal vascular fraction (SVF) cells for the treatment of non-reconstructable peripheral vascular disease in patients with critical limb ischemia: A 6-year follow-up showing durable effects
title_sort adipose derived stromal vascular fraction svf cells for the treatment of non reconstructable peripheral vascular disease in patients with critical limb ischemia a 6 year follow up showing durable effects
topic Peripheral vascular disease
Neovascularization
Stromal vascular fraction
Cell therapy
Arteriosclerosis
Diabetes
url http://www.sciencedirect.com/science/article/pii/S187350612030372X
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