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

Stem Cells Arabia

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Cerebral Palsy

Treatments

Biological: Stem Cell Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03078621

SCA-CP1

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

2 to 12 years old

Volunteers

No Healthy Volunteers

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