Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy
|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.
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|