A Phase 1/2 interventional study of Stem Cell Therapy in Cerebral Palsy, sponsored by Stem Cells Arabia. Status unknown. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2020-03-17.
Sponsored by Stem Cells Arabia · Phase 1/2, Interventional, and Treatment
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.
1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's planned enrollment of 50 is above the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Stem Cells Arabia is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Known history of:
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.
GMPM (Gross Motor Performance Measure) as a standard measurement tool for assessing quality of movement.
Time frame: 6 months
Motor function studies
Total volumes and specific tract lesions will be studied and correlated with functional outcomes.
Time frame: 1 year
Specific white matter tract analysis using MRI
Changes on brain Diffusion Tensor Image (DTI).
Time frame: 6 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Stem Cells Arabia