Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy
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|ClinicalTrials.gov Identifier: NCT01504594|
Recruitment Status : Suspended (Suspended because the lack of patients among the time this clinical trial was running.)
First Posted : January 5, 2012
Last Update Posted : August 9, 2013
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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiomyopathy, Dilated||Procedure: Intracoronary autologous stem cell infusion||Phase 1|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safeness and Effectiveness of Autologous Hematopoietic Cell Infusion Through Catheterization in Pediatric Patients With Dilated Cardiomyopathy|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||August 2013|
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
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 Name: Intracoronary CD34+ cell infusion
- Safeness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries. [ Time Frame: 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.
- Effectiveness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries. [ Time Frame: 6 months ]Patient will be assessed to measure and record any possible changes in his/her clinical and echocardiographic studies that will reflect improvement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504594
|University Hospital Dr. Jose E. Gonzalez|
|Monterrey, N.l., Mexico, 64460|
|Study Director:||Consuelo Mancias, Hematologist||Hematology Service, University Hospital of Monterrey|
|Principal Investigator:||Gerardo Sanchez, Cardiologist||Pediatrics Service, University Hospital of Monterrey|