Outcomes of Stem Cells for Cerebral Palsy

Vinmec Healthcare System

Status and phase: Completed; Phase 2

Conditions: Cerebral Palsy

Treatments: Biological: Autologous Bone Marrow Mononuclear Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02574923

TBG 002

Details and patient eligibility

About

The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in patients with cerebral palsy.

Full description

The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 30 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.

Enrollment: 30 patients

Sex: All

Ages: 2 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cerebral palsy of any types caused by oxygen deprivation.

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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30 participants in 1 patient group

Stem cell transplantation

Experimental group

Description:

2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward

Treatment:

Biological: Autologous Bone Marrow Mononuclear Cells