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Stem Cell Injection to Treat Heart Damage During Open Heart Surgery

NCT01557543 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-07-05

No results posted yet for this study

Summary

Background:

\- Bone marrow stromal stem cells (also known as mesenchymal stem cells) have been isolated and are found to make large amounts of growth factors. Because they make growth factors, these cells can help re-grow tissue and encourage repair of damaged tissue. Tests on damaged heart muscle suggest that injecting these cells directly into damaged heart muscle can improve heart function. Researchers want to give stem cells to people who are having open heart surgery to see if they can help to repair heart muscle damage.

Objectives:

\- To test the safety and effectiveness of bone marrow stromal stem cell injections given during heart surgery to treat heart muscle damage.

Eligibility:

\- Individuals at least 18 years of age who are scheduled to have open heart surgery for heart artery or vein blockages.

Design:

* Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected.
* Participants will have bone marrow taken from both hip bones about 3 weeks before the heart surgery.
* During the surgery, the stromal stem cells collected from the bone marrow will be given into the damaged portion of the heart muscle. The rest of the heart surgery will be performed according to standard procedures.
* After the surgery, participants will be monitored for complications from the stromal stem cells.
* Participants will have heart function tests to see if the stromal stem cell treatments were effective....

Conditions

Interventions

OTHER

Cell Therapy

Intramyocardial Injection of BMSCs

Sponsors & Collaborators

  • NIH Heart Center at Suburban Hospital

    collaborator UNKNOWN

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Pamela G Robey, Ph.D. · National Institute of Dental and Craniofacial Research (NIDCR)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2017-07-25
Completion
2018-06-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01557543 on ClinicalTrials.gov