Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy

Phase 1

Suspended

• Conditions: Cardiomyopathy, Dilated
• Interventions: Procedure: Intracoronary autologous stem cell infusion

• Registration Number: NCT01504594
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Brief Summary

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.

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 Timeline

• Study First Submitted: 2011-12-15
• Study Start: 2012-01
• Study First Submitted QC: 2012-01-04
• Study First Posted: 2012-01-05
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	Intracoronary autologous stem cell infusion	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.

Primary Outcome Measures

Name	Time	Method
Safeness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Dr. Jose E. Gonzalez; 🇲🇽 Monterrey, N.l., Mexico