Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus

Vinmec Research Institute of Stem Cell and Gene Technology

Status and phase: Completed; Phase 2

Conditions: Cerebral Palsy

Treatments: Combination Product: Stem cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03123562

VinmecRISCGT68

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of stem cells for cerebral palsy related to neonatal icterus

Full description

The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in 25 patients with cerebral palsy related to neonatal icterus at Vinmec International Hospital, Hanoi, Vietnam

Enrollment: 25 patients

Sex: All

Ages: 1 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cerebral palsy of any types caused by neonatal icterus

Exclusion criteria

• Epilepsy
• Hydrocephalus with ventricular drain
• Coagulation disorders
• Allergy to anesthetic agents
• Severe health conditions such as cancer, failure of heart, lung, liver or kidney
• Active infections

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Stem cell transplantation

Experimental group

Description:

Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward

Treatment:

Combination Product: Stem cell transplantation