Intrathecal Stem Cells for Cerebral Palsy Phase II (ISCII)
Cerebral Palsy
About this trial
This is an interventional supportive care trial for Cerebral Palsy focused on measuring brain, children, cerebral palsy, bone marrow stem cells, intrathecal autologous total nucleated cells, quadriparesis
Eligibility Criteria
Inclusion Criteria:
- Patients with quadriplegic cerebral palsy, with an age from 7 to 9 years of age, regardless the age at the time of injury, time post-injury, or previously received therapies, different from ours
Exclusion Criteria:
- Patients with neurodegenerative or autoimmune diseases
- Patients with active infection in any organ or tissue at the time of entering the study, the onset of stimulation with G-CSF or at the procedure
- Patients who do not sign the informed consent form
Sites / Locations
- Hematology Service, Hospital Universitario Dr. Jose E. GonzalezRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intrathecal Autologous Bone Marrow TNC
Control group
Procedure/Surgery: Intrathecal Autologous Bone Marrow TNC. Other Names: Autologous Stem Cell Transplantation Patients will be stimulated with Granulocyte Colony Stimulating Factor (G-CSF) (10mcgr/kg of body weight) for 3 consecutive days. Bone marrow will be harvested under sedation and, after being processed in the laboratory, the autologous TNC concentrate of 10 mL will be infused intrathecally.
Patients will be evaluated with the "Gross Motor Functional Classification System" initially, at one, three and six months, and then cross to the intervention arm.