Neural Stem Cells Therapy for Cerebral Palsy

The First Affiliated Hospital of Dalian Medical University

Status: Unknown

Conditions: Cerebral Palsy

Treatments: Other: the control group; Procedure: neural stem cells therapy group

Study type: Interventional

Funder types: Other

Identifiers

NCT03005249

LCKY2016-60

Details and patient eligibility

About

To evaluate the safety and efficacy of neural stem cells (NSCs) therapy for cerebral palsy.

Full description

Cerebral palsy is the most severe lifelong disability disease in childhood. In China, an epidemiological investigation of cerebral palsy in 2004 has reported that 2.74‰ (about 6.50-9.75 million) of children suffered from cerebral palsy. The costs of medical expenses, living allowance and nursing care can go up to RMB 20000-50000 yuan per year for each child with cerebral palsy and thus China will expend RMB 120-300 billion yuan per year for children with cerebral palsy. With full liberalization of two-child policy, there is an increasing number of second babies born to women who are 35 years or older. Thus, the incidence of cerebral palsy tends to increase. There is currently no cure for cerebral palsy, resulting in a heavy burden for families and on society. Recent clinical trials performed in countries outside China have demonstrated that stem cell therapy is likely the most effective method to treat cerebral palsy. Fifteen trials regarding stem cell therapy for cerebral palsy have been registered with ClinicalTrials.gov. In China, there have been no standardized registered trials regarding stem cell therapy for cerebral palsy, which greatly restricts its clinical application. In October 2016, the National Health and Family Planning Commission and the Food and Drug Administration of China jointly announced the premier stem cell clinical research institutions, making performing standardized trials regarding stem cell therapy for cerebral palsy in China possible.

Enrollment: 20 estimated patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Neonates with ischemic/hypoxic cerebral palsy (mainly including neonate with asphyxia and premature infants);
• Clinical manifestation of spastic tetraplegia;
• With moderate to severe cerebral palsy, The Gross Motor Function; Classification System (GMFCS) levels IV-V;
• Age 1-5 years, of either sex;
• Provision of signed informed consent by one of his/her parents or legal guardians prior to commencement of this study;

Exclusion criteria

• Systemic diseases that possibly influence treatment or patient's compliance;
• Potentially life-threatening diseases involving various organ systems;
• Brain deformity;
• Abnormal behaviors or mood disorder;
• Allergies from blood products;
• Suffering from infectious disease;
• Subjected to craniocerebral operations prior to screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

neural stem cells therapy group

Experimental group

Description:

The patients will be assigned to neural stem cells therapy group for cerebral palsy.

Treatment:

Procedure: neural stem cells therapy group

the control group

Experimental group

Description:

The patients will be assigned to the control group for cerebral palsy.

Treatment:

Other: the control group