Autologous Bone Marrow Mononuclear Cell Implantation and Its Impact on the Outcome of Patients With Critical Limb Ischemiaã- Results of a Randomized, Double-Blind, Placebo-Controlled Trial.
Circ J
; 81(11): 1713-1720, 2017 Oct 25.
Article
em En
| MEDLINE
| ID: mdl-28603176
ABSTRACT
BACKGROUND:
Cell therapy is a therapeutic option for patients presenting with nonrevascularizable critical limb ischemia (CLI). However there is a lack of firm evidence on its efficacy because of the paucity of randomized controlled trials.MethodsâandâResults:
The BALI trial was a multicenter, randomized, controlled, double-blind clinical trial that included 38 patients. For all of them, 500 mL of bone marrow were collected for preparation of a BM-MNC product that was implanted in patients assigned to active treatment. For the placebo group, a placebo cell-free product was implanted. Within 6 months after inclusion, major amputations had to be performed in 5 of the 19 placebo-treated patients and in 3 of the 17 BM-MNC-treated patients. According to a classical logistic regression analysis there was no significant difference. However, when using the jackknife analysis, 6 months after inclusion BM-MNC implantation was associated with a lower risk of major amputation (odds ratio (OR) 0.55; 95% confidence interval (CI) 0.52-0.58; P<0.0001) and of occurrence of any event (major or minor amputation, or revascularization) (OR 0.30; 95% CI 0.29-0.31; P<0.0001). The secondary endpoints (i.e., pain, ulcers, TcPO2, and ankle-brachial index value) were not statistically different between groups.CONCLUSIONS:
Our results suggested that cell therapy reduced the risk of major amputation in patients presenting with nonrevascularizable CLI.Palavras-chave
Texto completo:
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Monócitos
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Transplante de Medula Óssea
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Isquemia
Tipo de estudo:
Clinical_trials
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article