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This study is a single arm, single center trial to study the safety and efficacy of purified autologous bone marrow derived stem cells and mesenchymal stem cells for the treatment of children with cerebral palsy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem Cells | Experimental | Intravenous and Intrathecal transplantation of specific populations of purified bone marrow-derived stem cells and mesenchymal stem cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem Cell Therapy | Biological | Intravenous and Intrathecal transplantation of purified autologous bone marrow-derived stem cells and mesenchymal stem cells. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Motor Performance. | GMPM (Gross Motor Performance Measure) as a standard measurement tool for assessing quality of movement. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Motor function studies | Total volumes and specific tract lesions will be studied and correlated with functional outcomes. | 1 year |
| Specific white matter tract analysis using MRI | Changes on brain Diffusion Tensor Image (DTI). |
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Inclusion Criteria:
Exclusion Criteria:
Known history of:
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 6 months |