A randomized, controlled study of autologous therapy with bone marrow-derived aldehyde dehydrogenase bright cells in patients with critical limb ischemia

Emerson C. Perin, Guilherme Silva, Amir Gahremanpour, John Canales, Yi Zheng, Maria G. Cabreira-Hansen, Farrell Mendelsohn, Nicolas Chronos, Rebecca Haley, James T. Willerson, Brian H. Annex

Research output: Contribution to journalArticle

Abstract

Objectives: The safety and efficacy of direct intramuscular injections of aldehyde dehydrogenase bright (ALDH br) cells isolated from autologous bone marrow mononuclear cells (ABMMNCs) and ABMMNCs were studied in patients with critical limb ischemia (CLI) who were not eligible for percutaneous or surgical revascularization. Background: Many CLI patients are not candidates for current revascularization procedures, and amputation rates are high in these patients. Cell therapy may be a viable option for CLI patients. Methods: Safety was the primary objective and was evaluated by occurrence of adverse events. Efficacy, the secondary objective, was evaluated by assessment of Rutherford category, ankle-brachial index (ABI), transcutaneous partial pressure of oxygen (TcPO 2), quality of life, and pain. Results: ALDH br cells and ABMMNCs were successfully administered to all patients. No therapy-related serious adverse events occurred. Patients treated with ALDH br cells (n = 11) showed significant improvements in Rutherford category from baseline to 12 weeks (mean, 4.09 ± 0.30 to 3.46 ± 1.04; P = 0.05) and in ABI at 6 (mean, 0.22 ± 0.19 to 0.30 ± 0.24; P = 0.02), and 12 weeks (mean, 0.36 ± 0.18; P = 0.03) compared with baseline. Patients in the ABMMNC group (n = 10) showed no significant improvements at 6 or 12 weeks in Rutherford category but did show improvement in ABI from baseline to 12 weeks (0.38 ± 0.06 to 0.52 ± 0.16; P = 0.03). No significant changes from baseline were noted in ischemic ulcer grade or TcPO 2 in either group. Conclusions: Administration of autologous ALDH br cells appears to be safe and warrants further study in patients with CLI.

Original languageEnglish (US)
Pages (from-to)1060-1067
Number of pages8
JournalCatheterization and Cardiovascular Interventions
Volume78
Issue number7
DOIs
StatePublished - Dec 1 2011
Externally publishedYes

Fingerprint

Aldehyde Dehydrogenase
Ischemia
Extremities
Bone Marrow
Ankle Brachial Index
Bone Marrow Cells
Therapeutics
Safety
Partial Pressure
Intramuscular Injections
Cell- and Tissue-Based Therapy
Amputation
Ulcer
Quality of Life
Oxygen
Pain

Keywords

  • aldehyde dehydrogenase bright cells
  • autologous bone marrow mononuclear cells
  • limb ischemia
  • neoangiogenesis
  • peripheral arterial disease

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

A randomized, controlled study of autologous therapy with bone marrow-derived aldehyde dehydrogenase bright cells in patients with critical limb ischemia. / Perin, Emerson C.; Silva, Guilherme; Gahremanpour, Amir; Canales, John; Zheng, Yi; Cabreira-Hansen, Maria G.; Mendelsohn, Farrell; Chronos, Nicolas; Haley, Rebecca; Willerson, James T.; Annex, Brian H.

In: Catheterization and Cardiovascular Interventions, Vol. 78, No. 7, 01.12.2011, p. 1060-1067.

Research output: Contribution to journalArticle

Perin, EC, Silva, G, Gahremanpour, A, Canales, J, Zheng, Y, Cabreira-Hansen, MG, Mendelsohn, F, Chronos, N, Haley, R, Willerson, JT & Annex, BH 2011, 'A randomized, controlled study of autologous therapy with bone marrow-derived aldehyde dehydrogenase bright cells in patients with critical limb ischemia', Catheterization and Cardiovascular Interventions, vol. 78, no. 7, pp. 1060-1067. https://doi.org/10.1002/ccd.23066
Perin, Emerson C. ; Silva, Guilherme ; Gahremanpour, Amir ; Canales, John ; Zheng, Yi ; Cabreira-Hansen, Maria G. ; Mendelsohn, Farrell ; Chronos, Nicolas ; Haley, Rebecca ; Willerson, James T. ; Annex, Brian H. / A randomized, controlled study of autologous therapy with bone marrow-derived aldehyde dehydrogenase bright cells in patients with critical limb ischemia. In: Catheterization and Cardiovascular Interventions. 2011 ; Vol. 78, No. 7. pp. 1060-1067.
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abstract = "Objectives: The safety and efficacy of direct intramuscular injections of aldehyde dehydrogenase bright (ALDH br) cells isolated from autologous bone marrow mononuclear cells (ABMMNCs) and ABMMNCs were studied in patients with critical limb ischemia (CLI) who were not eligible for percutaneous or surgical revascularization. Background: Many CLI patients are not candidates for current revascularization procedures, and amputation rates are high in these patients. Cell therapy may be a viable option for CLI patients. Methods: Safety was the primary objective and was evaluated by occurrence of adverse events. Efficacy, the secondary objective, was evaluated by assessment of Rutherford category, ankle-brachial index (ABI), transcutaneous partial pressure of oxygen (TcPO 2), quality of life, and pain. Results: ALDH br cells and ABMMNCs were successfully administered to all patients. No therapy-related serious adverse events occurred. Patients treated with ALDH br cells (n = 11) showed significant improvements in Rutherford category from baseline to 12 weeks (mean, 4.09 ± 0.30 to 3.46 ± 1.04; P = 0.05) and in ABI at 6 (mean, 0.22 ± 0.19 to 0.30 ± 0.24; P = 0.02), and 12 weeks (mean, 0.36 ± 0.18; P = 0.03) compared with baseline. Patients in the ABMMNC group (n = 10) showed no significant improvements at 6 or 12 weeks in Rutherford category but did show improvement in ABI from baseline to 12 weeks (0.38 ± 0.06 to 0.52 ± 0.16; P = 0.03). No significant changes from baseline were noted in ischemic ulcer grade or TcPO 2 in either group. Conclusions: Administration of autologous ALDH br cells appears to be safe and warrants further study in patients with CLI.",
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AU - Perin, Emerson C.

AU - Silva, Guilherme

AU - Gahremanpour, Amir

AU - Canales, John

AU - Zheng, Yi

AU - Cabreira-Hansen, Maria G.

AU - Mendelsohn, Farrell

AU - Chronos, Nicolas

AU - Haley, Rebecca

AU - Willerson, James T.

AU - Annex, Brian H.

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