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Clinical trial

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

ID
Name
CS. ĐT.19H2
Description
To evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in-patient with neurological sequelae due to encephalitis or meningitis
Trial arms
Trial start
2014-06-16
Estimated PCD
2019-06-30
Trial end
2019-08-30
Status
Completed
Phase
Early phase I
Treatment
Stem cell transplantation
Transplantation of Autologous Bone Marrow Mononuclear Cells
Arms:
Stem cell transplantation
Size
22
Primary endpoint
Change in Total Score of Gross Motor Function Measure (GMFM-88)
Baseline, 6 months, and 12 months after transplantation
Change in Muscle Tone Assessed by Modified Ashworth Scale (MAS)
Baseline, 6 months, and 12 months after transplantation
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 22, 'type': 'ACTUAL'}}
Updated at
2024-06-06

1 organization

1 product

2 indications

Organization
Vinmec Research Institute of Stem Cell and Gene Technology
Product
Stem cell transplantation
Indication
Encephalitis
Indication
Meningitis