Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy

Cardiomyopathy, Dilated Clinical Trial

Official title:

Safeness and Effectiveness of Autologous Hematopoietic Cell Infusion Through Catheterization in Pediatric Patients With Dilated Cardiomyopathy

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01504594
• Other study ID #: HE-2012
• Status: Suspended
• Phase: Phase 1
• First received: December 15, 2011
• Last updated: August 6, 2013
• Start date: January 2012
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 16 Years

Eligibility

Inclusion Criteria:

• Ejection fraction less than 35 percent in echocardiogram

• More than 3 months with complete medical treatment without significant improvement

• Complete medical treatment: digitalics, diuretics, vasodilators and beta blockers

Exclusion Criteria:

• Not signing informed consent

• Active infection at enrolling time

• Inadequate G-CSF application

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated

Intervention

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.

Locations

Country	Name	City	State
Mexico	University Hospital Dr. Jose E. Gonzalez	Monterrey	N.l.

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes

External Links

•   Hematology Service, UANL webpage
•   University Hospital Dr. Jose E. Gonzalez