Autologous Progenitor Cell Therapy for Congestive Heart Failure Patients Undergoing CABG Surgery - Article Caverject; Edex Kit
Clinical Trial: Autologous Progenitor Cell Therapy for Congestive Heart Failure Patients Undergoing CABG Surgery
This study is currently recruiting patients.
Verified by Amit, Patel N, M.D. August 2005
|Heart Failure || Drug: Injection of Bone Marrow Progenitor Cells into the Heart ||Phase I |
MedlinePlus related topics: Cardiomyopathy
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety Study
Secondary Outcomes: Toxicity; Optimal dose of BMPCs
Expected Total Enrollment: 75
Study start: August 2005
Last follow-up: August 2005
- Age >=18 years.
- Patients with ischemic congestive heart failure undergoing primary isolated CABG.
- Congestive heart failure with ejection fraction <=40.
- Serum bilirubin, SGOT and SGPT <=2.5 time the upper level of normal.
- Serum creatinine < 2.0 times normal or no dialysis.
- NYHA performance status > = 3.
- Negative pregnancy test (in women with childbearing potential).
- Prior cardiac surgery.
- History of Prior Radiation Exposure
- History of Bone Marrow Disorder
- History of abnormal Bleeding or Clotting
- History of Liver Cirrhosis
- Inability to obtain 1 x 106 CD 34+ cells after bone marrow processing.
- Acute Myocardial Infarction < 6 days from acute event.
- Prior malignancy in the 5 years before treatment in this study (other than curatively treated carcinoma in-situ of the cervix or non-melanoma skin cancer).
- Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.
- Unable to have 250cc bone marrow harvested.
- History of ventricular arrhythmia if AICD is not present.
- History of ventricular aneurysm.
- Concurrent surgery such as CABG with valve surgery
- Pregnant or breastfeeding women.
Location and Contact Information
Joyce A. Szczepanski, BS, MBA 412-648-6307 firstname.lastname@example.org
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15213, United States; Recruiting
Amit N. Patel, MD, MS, Principal Investigator
Amit N. Patel, MD, MS, Principal Investigator, University of Pittsburgh
Last Updated: August 12, 2005
Record first received: August 12, 2005
ClinicalTrials.gov Identifier: NCT00130377
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23