NCT02231242

Intrathecal Stem Cells for Cerebral Palsy Phase II

Intrathecal Autologous Stem Cells for Children With Cerebral Palsy Phase II

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez · Academic / Other
• Sex: All
• Age: 7 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the infusion of intrathecal autologous bone marrow total nucleated cells would improve the neurologic evolution of pediatric patients with quadriparetic cerebral palsy.

Detailed description

There is accumulated evidence that shows that the administration of bone marrow total nucleated cells (TNC) into the brain may produce some benefits by different mechanisms like cytokine production, in several neurological areas such as motor, social, adaptative and cognitive. It has been found that after introducing TNC in the subarachnoid space of the spinal cord, these cells may be transported through the cerebrospinal fluid and can be delivered more efficiently to the injured area, compared with intravenous route in patients with neurologic injury. Patients will be stimulated for 3 consecutive days with subcutaneous granulocyte colony stimulating factor (G-CSF) and then their bone marrow will be harvested according to their weight. Bone marrow will be processed in order to obtain the buffy coat and minimize the amount of red blood cells. An inoculum of 10mL of this TNC will be infused intrathecally. Patients will be evaluated with the "Gross Motor Functional Classification System" before the procedure and one, three and six months after that.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Stem Cell Transplantation	Patients will be stimulated with Granulocyte Colony Stimulating Factor (G-CSF) 3 consecutive days. Bone marrow will be harvested under sedation and, after being processed in the laboratory, the buffy coat (TNC) of 10 mL will be infused intrathecally. Intrathecal Autologous Bone Marrow TNC

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-12-01
• Completion: 2016-06-01
• First posted: 2014-09-04
• Last updated: 2014-09-04

Locations

1 site across 1 country: Mexico