Clinical trial NCT01504594: Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy
Official title: Safeness and Effectiveness of Autologous Hematopoietic Cell Infusion Through Catheterization in Pediatric Patients With Dilated Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Cardiomyopathy, Dilated
Keywords: Dilated cardiomyopathy
Idiopathic
Bone Marrow
Stem Cells
CD34 +
Autologous
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Safeness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.
timeFrame: 6 weeks
Secondary outcomes:
measure: Effectiveness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.
timeFrame: 6 months
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: University Hospital Dr. Jose E. Gonzalez
state: N.l.
Study officials:
affiliation: Hematology Service, University Hospital of Monterrey
name: Consuelo Mancias, Hematologist
role: STUDY_DIRECTOR
affiliation: Pediatrics Service, University Hospital of Monterrey
name: Gerardo Sanchez, Cardiologist
role: PRINCIPAL_INVESTIGATOR
References: