NCT02241395
Withdrawn
Phase 1
Autologous Bone Marrow Mononuclear Cell Therapy in Cerebral Palsy
ConditionsCerebral Palsy
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cerebral Palsy
- Sponsor
- Neurogen Brain and Spine Institute
- Locations
- 1
- Primary Endpoint
- change in clinical symptoms over a period of 2 years
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study was to study the effect of autologous bone marrow mononuclear cells on common symptoms of cerebral palsy patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •diagnosed cases of any type of Cerebral Palsy
- •age above 6 months.
Exclusion Criteria
- •presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/ Hepatitis C Virus
- •malignancies
- •bleeding tendencies
- •pneumonia
- •renal failure
- •severe liver dysfunction
- •severe anemia \[Hemoglobin \< 8\]
- •any bone marrow disorder
- •space occupying lesion in brain
- •other acute medical conditions such as respiratory infection and pyrexia.
Outcomes
Primary Outcomes
change in clinical symptoms over a period of 2 years
Time Frame: 2 years
Clinical symptoms such as oromotor skills, sitting and standing balance, speech, ambulation, muscle tone, cognition, hand and leg movement, walking, etc
Secondary Outcomes
- Change in GMFM score(1 year)
- Change in Gross Motor Function Measure(1 year)
Study Sites (1)
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