Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 10:54 PM
Study NCT ID:
NCT01504594
Status:
SUSPENDED
Last Update Posted:
2013-08-09
First Post:
2011-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy
Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Organization:
Study Overview
Official Title:
Safeness and Effectiveness of Autologous Hematopoietic Cell Infusion Through Catheterization in Pediatric Patients With Dilated Cardiomyopathy
Status:
SUSPENDED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Suspended because the lack of patients among the time this clinical trial was running.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
* Premedication includes: Omeprazole (gastric protector), Ketorolac (anti-pain and swelling), ondansetron (antivomiting).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: