500 Boylston Street, Boston, MA 02116 617-419-4700
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The purpose of this 12-month, observational, follow-up study is to collect additional data
(by telephone contact) with which to assess the efficacy, safety, and effects of
intramyocardial injections of adult autologous CD34+ cells on quality of life (QoL) in
subjects with chronic refractory myocardial ischemia. No treatments will be administered
during this study. However, the investigators and other study site personnel and the
subjects will remain blinded to the treatment assignments from the core therapeutic study (#
24779) so as to provide a total of 24 months of blinded data.
Ages:21 - 81
Inclusion Criteria: - Subjects who have received treatment with Auto-CD34+ cells or with placebo and who have completed the final study visit (Month 12) of the core therapeutic study 24779 - Subjects who are willing to comply with the specified follow-up evaluations in this study and to provide written informed consent to participate in this study
Sponsor: Baxalta US Inc.
Trial ID: NCT00545610
Not Accepting Healthy Volunteers