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

NCT04080921 | Completed Phase 1 DMC

• 1 other identifier: CS. ĐT.19H2
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Encephalitis; Meningitis

Keywords

encephalitis; meningitis; neurological sequelae due

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Number of adverse events

  Through study completion, an average of 12 months

Study Arms (1)

Stem cell transplantation

EXPERIMENTAL

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

Combination Product: Stem cell transplantation

Interventions

Stem cell transplantation COMBINATION_PRODUCT

Transplantation of Autologous Bone Marrow Mononuclear Cells

Stem cell transplantation

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neurological sequelae due to encephalitis or meningitis

You may not qualify if:

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

Sponsors & Collaborators

• Vinmec Research Institute of Stem Cell and Gene Technology: lead

Study Sites (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, 100000, Vietnam

Location

Related 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.

  PMID: 28296863 RESULT

• 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.

  PMID: 28403842 RESULT

MeSH Terms

Conditions

Encephalitis; Meningitis

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Liem T Nguyen

  Vinmec Research Institute of Stem Cell and Gene Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 6, 2019
• Study Start: June 16, 2014
• Primary Completion: June 30, 2019
• Study Completion: August 30, 2019
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)