Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy

August 6, 2013 updated by: Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez

Safeness and Effectiveness of Autologous Hematopoietic Cell Infusion Through Catheterization in Pediatric Patients With Dilated Cardiomyopathy

The purpose of this study is to determine whether an autologous stem cell infusion through catheterism is safe and effective in the treatment of pediatric dilated cardiomyopathy.

Process:

  1. Primary Evaluation

    • Clinical History
    • Echocardiogram to evaluate ejection fraction and other parameters
  2. Signing of Informed Consent and clearing doubts
  3. Bone Marrow stimulation for 3 consecutive days with G-CSF (Granulocyte Colony Stimulating Factor) applied subcutaneously
  4. On the 4th day, in operation room and under sedation: Bone Marrow Harvest performed by hematologists through posterior iliac crests(amount calculated at 8cc/kg, without exceeding 150ml).
  5. Recovery room with family members while the cells are being processed in the Hematology Laboratory.
  6. Approximately 3 hours after the 1st procedure, the patient re-enters the operation room, which is equipped for cardiac catheterization, so that cardiologists infuse the stem cells through the femoral artery into the coronary arteries which irrigate the heart´s muscle fibers.
  7. Patient goes back to the recovery area until the anesthesia effect is gone and can tolerate oral liquids.
  8. Clinical and echocardiographic follow-ups at 6 weeks and 6 months after the procedure.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

  • The Patient will receive standard surgical care, accompanied by a nurse at all times.
  • Premedication includes: Omeprazole (gastric protector), Ketorolac (anti-pain and swelling), ondansetron (antivomiting).

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • N.l.
      • Monterrey, N.l., Mexico, 64460
        • University Hospital Dr. Jose E. Gonzalez

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

1 year to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ejection fraction less than 35 percent in echocardiogram
  • More than 3 months with complete medical treatment without significant improvement
  • Complete medical treatment: digitalics, diuretics, vasodilators and beta blockers

Exclusion Criteria:

  • Not signing informed consent
  • Active infection at enrolling time
  • Inadequate G-CSF application

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: Patients
Children which meet eligibility criteria and after being assessed, are stimulated with G-CSF, undergo bone marrow extraction and then have them applied directly to the coronary arteries through cardiac catheterization.
Procedure: Intracoronary autologous stem cell infusion
Under sedation and under sterile conditions in a fluoroscopy operation room, cardiac catheterization will be performed through the femoral artery to infuse the stem cells directly into the heart´s coronary arteries.
Other Names:
  • Intracoronary CD34+ cell infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safeness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.
Time Frame: 6 weeks
Patient will be assessed to prove that the procedure did not cause any deterioration of his/her health presented at the beginning of the study.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.
Time Frame: 6 months
Patient will be assessed to measure and record any possible changes in his/her clinical and echocardiographic studies that will reflect improvement.
6 months

Collaborators and Investigators

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

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Investigators

  • Study Director: Consuelo Mancias, Hematologist, Hematology Service, University Hospital of Monterrey
  • Principal Investigator: Gerardo Sanchez, Cardiologist, Pediatrics Service, University Hospital of Monterrey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

January 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

December 15, 2011

First Submitted That Met QC Criteria

January 4, 2012

First Posted (Estimate)

January 5, 2012

Study Record Updates

Last Update Posted (Estimate)

August 9, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE-2012

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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