Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy
NCT ID: NCT01504594
Last Updated: 2013-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE1
10 participants
INTERVENTIONAL
2012-01-31
2013-08-31
Brief Summary
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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
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* Premedication includes: Omeprazole (gastric protector), Ketorolac (anti-pain and swelling), ondansetron (antivomiting).
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* More than 3 months with complete medical treatment without significant improvement
* Complete medical treatment: digitalics, diuretics, vasodilators and beta blockers
Exclusion Criteria
* Active infection at enrolling time
* Inadequate G-CSF application
1 Year
16 Years
ALL
No
Sponsors
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Hospital Universitario Dr. Jose E. Gonzalez
OTHER
Responsible Party
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Consuelo Mancias Guerra
Pediatric Hematology Professor
Principal Investigators
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Consuelo Mancias, Hematologist
Role: STUDY_DIRECTOR
Hematology Service, University Hospital of Monterrey
Gerardo Sanchez, Cardiologist
Role: PRINCIPAL_INVESTIGATOR
Pediatrics Service, University Hospital of Monterrey
Locations
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University Hospital Dr. Jose E. Gonzalez
Monterrey, N.l., Mexico
Countries
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Related Links
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University Hospital Dr. Jose E. Gonzalez
Other Identifiers
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HE-2012
Identifier Type: -
Identifier Source: org_study_id