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A 12-Month Follow-Up Study to Protocol 24779 (A Double-blind, Prospective, Randomized, Placebo-controlled Study to Determine the Tolerability, Efficacy, Safety, and Dose Range of Intramyocardial Injec

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Trial Conditions
  • Myocardial Ischemia
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
21  - 81 

Gender:
Both

Eligibility

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

Gender: Both
Facilities
  • St. Elizabeth's Medical Center - Completed
Other Information

Sponsor: Baxter Healthcare Corporation
Phase: N/A
Trial ID: NCT00545610
Volunteers:  Not Accepting Healthy Volunteers

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