Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Safety and Efficacy of Transplantation of Specific Populations of Stem Cells and Mesenchymal Stem Cells for the Treatment of Cerebral Palsy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03078621
• Other study ID #: SCA-CP1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2016
• Est. completion date: January 2021

Study information

• Verified date: March 2020
• Source: Stem Cells Arabia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

• Other etiologies such as degenerative, mitochondrial, and metabolic disorders

• Normal brain MRI

• Evidence of acute illness such as fever (temperature > 37.5 C), vomiting, diarrhea, wheezing or crackles

• Progressing neurological disease (Batten Disease, Leukodystrophies, Neurotransmitter disorders)

• Microcephaly, macrocephaly, cortical malformations, or genetic disorders of dysgenesis

• Pulmonary disease requiring ventilator support

• Unwillingness to return for follow-up visits

• Contraindications to MRI

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Biological:
• Stem Cell Therapy
Intravenous and Intrathecal transplantation of purified autologous bone marrow-derived stem cells and mesenchymal stem cells.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stem Cells Arabia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Motor Performance.	GMPM (Gross Motor Performance Measure) as a standard measurement tool for assessing quality of movement.	6 months
Secondary	Motor function studies	Total volumes and specific tract lesions will be studied and correlated with functional outcomes.	1 year
Secondary	Specific white matter tract analysis using MRI	Changes on brain Diffusion Tensor Image (DTI).	6 months