Autologous/Allogeneic Progenitor Stem Cell Therapy for Congestive Heart Failure

January 17, 2018 updated by: Amit N. Patel MD MS, Amit, Patel N, M.D.

Phase 1 Study: Autologous/Allogeneic Bone Marrow Progenitor Cell Treatment for Heart Failure

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: open
open treatment
Procedure: Injection of bone marrow cells in the heart
Biological implant into the heart
Biological: Biological bone marrow cell therapy
Biological implant into the heart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Heart function at 3 months after implant
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amit, Patel N, M.D.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2005

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 8, 2005

First Submitted That Met QC Criteria

August 8, 2005

First Posted (Estimate)

August 9, 2005

Study Record Updates

Last Update Posted (Actual)

January 19, 2018

Last Update Submitted That Met QC Criteria

January 17, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #:0504126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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