Ignite Creation Date:
2024-05-06 @ 12:09 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01504594
Status:
SUSPENDED
Last Update Posted:
2013-08-09
First Post:
2011-12-15
Brief Title:
Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy
Sponsor:
Hospital Universitario Dr Jose E Gonzalez
Organization:
Hospital Universitario Dr Jose E Gonzalez
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 crestsamount calculated at 8cckg 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 hearts 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 crestsamount calculated at 8cckg 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 hearts 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:
None
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?:
None