NCT03005249

Neural Stem Cells Therapy for Cerebral Palsy

Neural Stem Cells Therapy for Cerebral Palsy: a Prospective, Randomized, Parallel-controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital of Dalian Medical University · Academic / Other
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
PROCEDURE	neural stem cells therapy group	The patients will be assigned to neural stem cells therapy group for cerebral palsy.
OTHER	the control group	The patients will be assigned to the control group for cerebral palsy.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-09-01
• Completion: 2019-12-01
• First posted: 2016-12-29
• Last updated: 2018-08-29

Locations

1 site across 1 country: China