Intrathecal Stem Cells for Cerebral Palsy Phase II (ISCII)
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|ClinicalTrials.gov Identifier: NCT02231242|
Recruitment Status : Unknown
Verified September 2014 by Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez.
Recruitment status was: Recruiting
First Posted : September 4, 2014
Last Update Posted : September 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Biological: Autologous Stem Cell Transplantation||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Intrathecal Autologous Stem Cells for Children With Cerebral Palsy Phase II|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||June 2016|
Experimental: Intrathecal Autologous Bone Marrow TNC
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.
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
No Intervention: Control group
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.
- Number of participants who show progress in GMFCS scale after autologous bonemarrow TNC intrathecal infusion. [ Time Frame: six months ]
Patients, in an outpatient basis, will be stimulated with Granulocyte Colony Stimulating Factor (G-CSF) for 3 consecutive days. Their bone marrow will be harvested under sedation and, after being processed in the laboratory, the buffy coat of 10 mL will be infused intrathecally.
Patient will be monitored during acute phase to register any adverse effect (malaise, headache, fever, and nausea or vomit, etc).Gross Motor Function Classification System (GMFCS) scale is going to be monitored at baseline, one, three and six months to measured differences between the scales.
GMFCS is based on patient's self-initiated movement with particular emphasis on sitting, walking, and wheeled mobility. Distinctions between levels are based on functional abilities, the need for assistive technology, including hand-held mobility devices (walkers, crutches, or canes) or wheeled mobility, and to a much lesser extent, quality of movement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231242
|Contact: Consuelo Mancias-Guerra, MD||+52 81 83 48 61 36 ext email@example.com|
|Contact: Oscar Gonzalez-Llano, MD||+52 86 75 67 firstname.lastname@example.org|
|Hematology Service, Hospital Universitario Dr. Jose E. Gonzalez||Recruiting|
|Monterrey, Nuevo Leon, Mexico, 64460|
|Contact: Consuelo Mancias-Guerra, MD +52 81 83 48 61 36 ext 413 email@example.com|
|Contact: David Gomez-Almaguer, MD +52 81 83 48 61 36 firstname.lastname@example.org|
|Principal Investigator: Consuelo Mancias-Guerra, MD|
|Principal Investigator:||Consuelo Mancias-Guerra, MD||Hospital Universitario Dr. Jose E. Gonzalez|