NCT00128258

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2005

Longer than P75 for phase_1

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

11.6 years

First QC Date

August 8, 2005

Last Update Submit

January 17, 2018

Conditions

Heart Failure, Congestive

Keywords

Stem CellHeart FailureBone Marrow

Outcome Measures

Primary Outcomes (1)

  • Heart function at 3 months after implant

    3 months

Secondary Outcomes (1)

  • Toxicity

    3 months

Study Arms (1)

open

EXPERIMENTAL

open treatment

Procedure: Injection of bone marrow cells in the heartBiological: Biological bone marrow cell therapy

Interventions

Injection of bone marrow cells in the heartPROCEDURE

Biological implant into the heart

open
Biological bone marrow cell therapyBIOLOGICAL

Biological implant into the heart

open

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 9, 2005

Study Start

May 1, 2005

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 19, 2018

Record last verified: 2018-01