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

Meningitis Clinical Trial

Official title:

The Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation In-patient With Neurological Sequelae Due to Encephalitis or Meningitis at Vinmec International Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080921
• Other study ID #: CS. ÐT.19H2
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 16, 2014
• Est. completion date: August 30, 2019

Study information

• Verified date: June 2024
• Source: Vinmec Research Institute of Stem Cell and Gene Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Encephalitis
• Meningitis

Intervention

Combination Product:
• Stem cell transplantation
Transplantation of Autologous Bone Marrow Mononuclear Cells

Locations

Country	Name	City	State
Vietnam	Vinmec Research Institute of Stem Cell and Gene Technology	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Vinmec Research Institute of Stem Cell and Gene Technology

Country where clinical trial is conducted

Vietnam, 

References & Publications (2)

Bansal H, Singh L, Verma P, Agrawal A, Leon J, Sundell IB, Koka PS. Administration of Autologous Bone Marrow-Derived Stem Cells for Treatment of Cerebral Palsy Patients: A Proof of Concept. J Stem Cells. 2016;11(1):37-49. — View Citation

Nguyen LT, Nguyen AT, Vu CD, Ngo DV, Bui AV. Outcomes of autologous bone marrow mononuclear cells for cerebral palsy: an open label uncontrolled clinical trial. BMC Pediatr. 2017 Apr 12;17(1):104. doi: 10.1186/s12887-017-0859-z. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Score of Gross Motor Function Measure (GMFM-88)	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	Baseline, 6 months, and 12 months after transplantation
Primary	Change in Muscle Tone Assessed by Modified Ashworth Scale (MAS)	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	Baseline, 6 months, and 12 months after transplantation
Secondary	Number of adverse events	Examples of adverse events to look for: fever, infections, vomit, epilepsy	Through study completion, an average of 12 months