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Suspended because the lack of patients among the time this clinical trial was running.
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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:
Primary Evaluation
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracoronary autologous stem cell infusion | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safeness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries. | 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries. | Patient will be assessed to measure and record any possible changes in his/her clinical and echocardiographic studies that will reflect improvement. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Consuelo Mancias, Hematologist | Hematology Service, University Hospital of Monterrey | Study Director |
| Gerardo Sanchez, Cardiologist | Pediatrics Service, University Hospital of Monterrey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Dr. Jose E. Gonzalez | Monterrey | N.l. | 64460 | Mexico |
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| Label | URL |
|---|---|
| University Hospital Dr. Jose E. Gonzalez | View source |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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|
| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |