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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04080921
Other study ID # CS. ÐT.19H2
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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