Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy

Study Overview
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Brief Summary
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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: Primary Evaluation Clinical History Echocardiogram to evaluate ejection fraction and other parameters Signing of Informed Consent and clearing doubts Bone Marrow stimulation for 3 consecutive days with G-CSF (Granulocyte Colony Stimulating Factor) applied subcutaneously 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). Recovery room with family members while the cells are being processed in the Hematology Laboratory. 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. Patient goes back to the recovery area until the anesthesia effect is gone and can tolerate oral liquids. Clinical and echocardiographic follow-ups at 6 weeks and 6 months after the procedure.

Detailed Description
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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).

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

Conditions
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Cardiomyopathy, Dilated

Intervention / Treatment
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* Procedure: Intracoronary autologous stem cell infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>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<br>* 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.<br>* Other names: Intracoronary CD34+ cell infusion;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dilated cardiomyopathy, Idiopathic, Bone Marrow, Stem Cells, CD34 +, Autologous