Safety and Efficacy of Transplantation of Specific Populations of Stem Cells and Mesenchymal Stem Cells for the Treatment of Cerebral Palsy
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cerebral Palsy
- Sponsor
- Stem Cells Arabia
- Enrollment
- 50
- Primary Endpoint
- Changes in Motor Performance.
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must be more than 2 year of age and less than 12 years of age at the time of screening for inclusion in the study.
- •Clinical evidence of a non-progressive motor disability due to brain dysfunction.
- •Willing to comply with all study procedures.
- •Gross Motor Function Classification Score level II-V
Exclusion Criteria
- •Known history of:
- •Intractable seizures
- •Traumatic brain injury
- •Genetic disorder
- •Current Infection
- •Renal insufficiency
- •Hepatic disease
- •HIV+ (as demonstrated by positive blood test)
- •Immunosuppression
- •Infectious related neurological injury
Outcomes
Primary Outcomes
Changes in Motor Performance.
Time Frame: 6 months
GMPM (Gross Motor Performance Measure) as a standard measurement tool for assessing quality of movement.
Secondary Outcomes
- Motor function studies(1 year)
- Specific white matter tract analysis using MRI(6 months)