Stem Cell Transplantation In-patient With Neurological Sequelae Due to Encephalitis or Meningitis

Phase 1

Completed

• Conditions: Encephalitis; Meningitis
• Interventions: Combination Product: Stem cell transplantation

• Registration Number: NCT04080921
• Lead Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology

Brief Summary

To evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in-patient with neurological sequelae due to encephalitis or meningitis

Detailed Description

The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mononuclear cell in 22 patients with neurological sequelae due to encephalitis or meningitis at Vinmec International Hospital, Hanoi, Vietnam

Study Timeline

• Study Start: 2014-06-16
• Primary Completion: 2019-06-30
• Study Completion: 2019-08-30
• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-06
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Neurological sequelae due to encephalitis or meningitis

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Total Score of Gross Motor Function Measure (GMFM-88)	Baseline, 6 months, and 12 months after transplantation	The Gross Motor Function Measure - 88 items (GMFM-88) is a standardized observational tool used to evaluate changes in gross motor function in children with cerebral palsy and other disabilities. The total score ranges from 0 to 264, with higher scores representing better gross motor function
Change in Muscle Tone Assessed by Modified Ashworth Scale (MAS)	Baseline, 6 months, and 12 months after transplantation	The Modified Ashworth Scale (MAS) is a clinical tool used to measure muscle tone and the degree of spasticity in patients with neurological conditions. The scale ranges from 0 to 4, with an additional 1+ category. Scores are interpreted as follows: 0 indicates no increase in muscle tone, 1 indicates a slight increase in muscle tone with a catch and release, 1+ indicates a slight increase with minimal resistance throughout the remainder of the range of motion, 2 indicates a more marked increase in muscle tone through most of the range of motion, 3 indicates considerable increase in muscle tone making passive movement difficult, and 4 indicates that the affected part(s) are rigid in flexion or extension. Lower scores represent better outcomes (normal muscle tone), while higher scores represent worse outcomes

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	Through study completion, an average of 12 months	Examples of adverse events to look for: fever, infections, vomit, epilepsy

Trial Locations

Locations (1)

Vinmec Research Institute of Stem Cell and Gene Technology; 🇻🇳 Hanoi, Vietnam