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A Double-blind, Prospective, Randomized, Placebo-controlled Study to Determine the Tolerability, Efficacy, Safety, and Dose Range of Intramyocardial Injections of G-CSF Mobilized Auto-CD34+ Cells for

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

The purpose of this study is to evaluate the efficacy and safety of intramyocardial injections of adult stem cells in patients with refractory chronic myocardial ischemia.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
21  - 80 

Gender:
Both

Eligibility

Inclusion Criteria:

- 21-80 years of age

- CCS functional class III or IV chronic refractory angina

- unsuitable for conventional revascularization

Exclusion Criteria:

- predominant congestive heart failure

- left ventricular ejection fraction of less than 25% at screening

- myocardial infarction within 60 days of treatment

- successful coronary revascularization within 6 months of study enrollment

- history of moderate to severe aortic stenosis or prosthetic aortic valve

- co-morbidity associated with life expectancy of less than 1 year

Gender: Both
Steward Physician(s)
  • Baxter Healthcare Corporation
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Device
  • stem cell injection
Physician Researcher

Investigator Name:

  • Baxter Healthcare Corporation

Other Information

Sponsor: Baxter Healthcare Corporation
Phase: Phase 2
Trial ID: NCT00300053
Volunteers:  Not Accepting Healthy Volunteers

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