Abstract 5638: Autologous CD34+ Cell Therapy for Refractory Angina: 12 Month Results of the Phase II ACT34-CMI Study
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Le résumé fourni par la source
Background: Refractory angina(Ang) effects 150 –250,000 pts in the US alone. These individuals have exhausted options for revasc and continue to have lifestyle limiting ang despite optimal medical Rx. Pre-clinical studies provided evidence that human CD34+ cells(CD34) can stimulate new blood vessel formation in ischemic myocardium(Myo), improving perfusion and function. We performed a phase 2 study of intraMyo injection of autologous CD34 in pts with CCS Class 3 and 4 Ang to obtain evidence for feasibility, safety and bioactivity. Methods: A phase 2 randomized, double-blind, placebo-controlled clinical trial was performed at 26 centers in the United States. There were 3 treatment groups: placebo, low dose (1×10^5 CD34/kg body wt) and high dose (5×10^5 CD34/kg). All pts underwent mobilization with GCSF 5 mcg/kg/day SC for 5 d, followed by apheresis on d5 to collect mononuclear cells. On day 6 CD34 were purified from the collected cells using the Isolex 300i device. After lot release testing, CD34 were injected endocardially at 10 locations in the ischemic Myo using the Myostar catheter following NOGA mapping. Placebo injections consisted of identical volumes of the diluent only. Results: A total of 167 pts were randomized and completed the injection procedure and 162 completed the 6 mo evaluation. The mean age of subjects was 61.0±8.9, there were 22 female and 145 male subjects. Trop was elevated in 26 pts at baseline and in 71 at some point following GCSF or injection. At 6 mo CD34 treated pts showed more reduction in ang frequency (−8.6 placebo vs 14.2 low dose) and improved ETT time (+69 sec placebo vs. +138 low dose). At 12m CD34 treated continue to show more reduction in angina (−8.2 placebo vs. −15.0 low dose) and improved ETT (+58 sec placebo vs. + 139 sec low dose). For key endpoints the high dose group results were inferior to low dose. The 12m data set has been locked and is being analyzed and the results of the completed analysis will be presented. Conclusions: Autologous CD34 cell therapy was associated with improved exercise tolerance and reduced angina in no-option pts with intractable angina. Ongoing analysis will determine endpoints, sample size and suitability of this therapy for a phase III study in no-option pts with refractory angina.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Abstract 5638: Autologous CD34+ Cell Therapy for Refractory Angina: 12 Month Results of the Phase II ACT34-CMI Study
- Date Crossref
- 03/11/2009
- Éditeur
- Ovid Technologies (Wolters Kluwer Health)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Minneapolis Heart Institute Foundation pays non établi dans la noticeInstitution
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Scripps Green Hospital pays non établi dans la noticeÉtablissement de santé
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UPMC Health System pays non établi dans la noticeÉtablissement de santé
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Case Western Reserve University pays non établi dans la noticeUniversité ou école supérieure
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Rush University pays non établi dans la noticeUniversité ou école supérieure
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Holy Cross Hospital pays non établi dans la noticeÉtablissement de santé
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St. Elizabeth's Medical Center pays non établi dans la noticeÉtablissement de santé
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Saint Joseph’s Translational Research Institute pays non établi dans la noticeOrganisation à but non lucratif
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Mayo Clinic in Arizona pays non établi dans la noticeÉtablissement de santé
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Swedish Medical Center pays non établi dans la noticeÉtablissement de santé
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University of Cincinnati pays non établi dans la noticeUniversité ou école supérieure
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Stanford University pays non établi dans la noticeUniversité ou école supérieure
Minneapolis Heart Institute Foundation, Scripps Green Hospital et UPMC Health System, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.