Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy

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

Status

Suspended

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01504594

Enrollment

Registered

2012-01-05

Start date

2012-01-31

Completion date

2013-08-31

Last updated

2013-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy, Dilated

Keywords

Dilated cardiomyopathy, Idiopathic, Bone Marrow, Stem Cells, CD34 +, Autologous

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.

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).

Interventions

PROCEDUREIntracoronary 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 16 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safeness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.	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.

Secondary

Measure	Time frame	Description
Effectiveness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.	6 months	Patient will be assessed to measure and record any possible changes in his/her clinical and echocardiographic studies that will reflect improvement.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026