Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy

Hospital Universitario Dr. Jose E. Gonzalez

Status and phase: Suspended; Phase 1

Conditions: Cardiomyopathy, Dilated

Treatments: Procedure: Intracoronary autologous stem cell infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01504594

HE-2012

Details and patient eligibility

About

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.

Full 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).

Enrollment: 10 estimated patients

Sex: All

Ages: 1 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Patients

Experimental group

Description:

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.

Treatment:

Procedure: Intracoronary autologous stem cell infusion