Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy
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|ClinicalTrials.gov Identifier: NCT03078621|
Recruitment Status : Active, not recruiting
First Posted : March 13, 2017
Last Update Posted : June 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Biological: Stem Cell Therapy||Phase 1 Phase 2|
Cerebral palsy (CP) is a chronic childhood disorder defined by a range of motor and cognitive impairments and results in a substantial suffering to the patient and a tremendous socio-economic burden to the individual, family, and healthcare system. With no effective treatments or interventions, therapies for CP are currently focused on supportive and management strategies. Stem cell transplantation has been suggested as a putative intervention for neural pathology, as mesenchymal and neural stem cells, as well as olfactory ensheathing glia and Schwann cells, which have shown some regenerative and functional efficacy in experimental central nervous system disorders.
In this trial, the investigators study the safety and efficacy of the intrathecal transplantation of specific populations of purified autologous bone marrow-derived stem cells and mesenchymal stem cells in patients with cerebral palsy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Transplantation of Specific Populations of Stem Cells and Mesenchymal Stem Cells for the Treatment of Cerebral Palsy|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: Stem Cells
Intravenous and Intrathecal transplantation of specific populations of purified bone marrow-derived stem cells and mesenchymal stem cells.
Biological: Stem Cell Therapy
Intravenous and Intrathecal transplantation of purified autologous bone marrow-derived stem cells and mesenchymal stem cells.
- Changes in Motor Performance. [ Time Frame: 6 months ]GMPM (Gross Motor Performance Measure) as a standard measurement tool for assessing quality of movement.
- Motor function studies [ Time Frame: 1 year ]Total volumes and specific tract lesions will be studied and correlated with functional outcomes.
- Specific white matter tract analysis using MRI [ Time Frame: 6 months ]Changes on brain Diffusion Tensor Image (DTI).