Abstract | OBJECTIVES: 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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Authors | 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 |
Journal | Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
(Catheter Cardiovasc Interv)
Vol. 78
Issue 7
Pg. 1060-7
(Dec 01 2011)
ISSN: 1522-726X [Electronic] United States |
PMID | 21594960
(Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | Copyright © 2011 Wiley Periodicals, Inc. |
Chemical References |
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Topics |
- Aged
- Aged, 80 and over
- Aldehyde Dehydrogenase
(metabolism)
- Ankle Brachial Index
- Bone Marrow Cells
(enzymology)
- Bone Marrow Transplantation
(adverse effects)
- Cell Separation
(methods)
- Critical Illness
- Double-Blind Method
- Extremities
(blood supply)
- Female
- Flow Cytometry
- Hemodynamics
- Humans
- Injections, Intramuscular
- Ischemia
(diagnosis, enzymology, physiopathology, surgery)
- Male
- Middle Aged
- Recovery of Function
- Regional Blood Flow
- Time Factors
- Transplantation, Autologous
- Treatment Outcome
- United States
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