Autologous/Allogeneic Progenitor Stem Cell Therapy for Congestive Heart Failure

NCT ID: NCT00128258

Last Updated: 2018-01-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-01
• Study Completion Date: 2016-12-01

Brief Summary

This research study is being performed to find out more information about the safety and effectiveness of injecting bone marrow progenitor cells (BMPCs) from one's own hip bone into one's heart muscle. 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 investigators 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 investigator's plan to inject an eligible participant's heart with cells that are from one's own bone marrow during an operation to receive a ventricular assist device (VAD) or partial artificial heart and then to study the function of the heart while awaiting a heart transplant. The investigators will then examine the heart after it has been removed as part of the regular heart transplant operation for any microscopic changes (changes too small to be seen by the unaided eye but large enough to be studied under a microscope) at the site where the cells are injected. Participants will have no change in the chances of receiving a heart transplant by agreeing to participate in this study. There will also be no delay in receiving a VAD operation while waiting to participate in this study. This Phase I study has been cleared by the Food and Drug Administration (FDA) to enroll and treat patients. The Center for Biologics Evaluation and Research Investigational New Drug number (IND BB #) is 12304. (A Phase I trial is a research study using techniques or products in the first-stage or for the first time in human subjects).

Conditions

Heart Failure, Congestive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

open

open treatment

Group Type: EXPERIMENTAL

Injection of bone marrow cells in the heart

Intervention Type: PROCEDURE

Biological implant into the heart

Biological bone marrow cell therapy

Intervention Type: BIOLOGICAL

Biological implant into the heart

Interventions

Injection of bone marrow cells in the heart

Biological implant into the heart

Intervention Type: PROCEDURE

Biological bone marrow cell therapy

Biological implant into the heart

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Age >=18 years.
• Congestive heart failure with ejection fraction <= 35.
• Candidates for ventricular device placement as a bridge to transplant.
• 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

• Pregnant or breastfeeding women.
• 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.
• Eligible for destination ventricular assist device placement.
• Unable to have 250cc bone marrow harvested.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amit, Patel N, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Amit N. Patel MD MS

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

#:0504126

Identifier Type: -

Identifier Source: org_study_id