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Autologous Progenitor Stem Cell Therapy for Congestive Heart Failure Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery
This study is currently recruiting participants.
Verified by Amit, Patel N, M.D., August 2005
Sponsors and Collaborators: Amit, Patel N, M.D.
University of Pittsburgh
Information provided by: Amit, Patel N, M.D.
ClinicalTrials.gov Identifier: NCT00130377
  Purpose

This research study is being performed to find out more information about the safety of injecting bone marrow (from one's own hip bone) progenitor cells (BMPCs) into one's heart muscle. The study may also determine the optimal dose of BMPCs for congestive heart failure. The BMPCs are the cells from which the different types of blood and other cells grow. In patients with heart failure, the heart muscle does not pump well. Over a period of years, this continues to get worse until the patient dies of heart failure. The researchers are trying to find out if the injection of these BMPCs can make a change in the functioning of these areas of the heart muscle. Data from studies around the world have suggested that when patients with heart failure receive these cells by direct injection into their hearts they show signs of recovered heart function; however, there has been no evidence from actual studies of the cells of the patient’s hearts to show how this process works. It is the researcher's plan to inject either plain serum (the liquid part of the blood that does not contain any blood cells) or cells from the participant's own bone marrow (BMPCs) into his or her heart during one's coronary artery bypass grafting operation (CABG) and then to study the function of the heart. The researchers are trying to find out if the injection of these BMPCs into the damaged areas of the heart muscle can improve the functioning of these areas. The Food and Drug Administration (FDA) has approved enrollment of patients into Phase I of this study (a Phase I trial is a research study using techniques, or products for the first time in human subjects).


Condition Intervention Phase
Heart Failure, Congestive
Procedure: Injection of Bone Marrow Progenitor Cells into the Heart
Phase I

MedlinePlus related topics: Coronary Artery Bypass Surgery Heart Failure
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety Study
Official Title: Phase 1 Study: Autologous Bone Marrow Progenitor Cell Treatment for Patients With Congestive Heart Failure Undergoing CABG Surgery

Further study details as provided by Amit, Patel N, M.D.:

Primary Outcome Measures:
  • Heart function change 6 months post-implant

Secondary Outcome Measures:
  • Toxicity
  • Optimal dose of BMPCs

Estimated Enrollment: 75
Study Start Date: August 2005
Estimated Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 times the upper level of normal.
  • Serum creatinine < 2.0 times normal or no dialysis.
  • New York Heart Association (NYHA) performance status > = 3.
  • Negative pregnancy test (in women with childbearing potential).

Exclusion Criteria:

  • 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 10^6 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 of bone marrow harvested.
  • History of ventricular arrhythmia if automatic implantable cardioverter-defibrillator (AICD) is not present.
  • History of ventricular aneurysm.
  • Concurrent surgery such as CABG with valve surgery
  • Pregnant or breastfeeding women.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130377

Contacts
Contact: Amit N. Patel, MD, MS 412-648-6411 patelan@upmc.edu
Contact: Lynette Beattie, BSN 412-648-6411 beattieln@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Amit N. Patel, MD, MS     412-648-6411     patelan@upmc.edu    
Principal Investigator: Amit N. Patel, MD, MS            
Sponsors and Collaborators
Amit, Patel N, M.D.
University of Pittsburgh
Investigators
Principal Investigator: Amit N. Patel, MD, MS University of Pittsburgh
  More Information

Study ID Numbers: 0506137
Study First Received: August 12, 2005
Last Updated: September 6, 2006
ClinicalTrials.gov Identifier: NCT00130377  
Health Authority: United States: Food and Drug Administration

Keywords provided by Amit, Patel N, M.D.:
Stem Cell
Heart Failure
Bone Marrow

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009