This Study is Single arm, Single Centre trial to study the safety and efficacy of bone marrow derived autologous mononuclear cells (100 millions per dose)study enrollment duration 36 months sample size 100 patients should be treated (above 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern.
Cerebral Palsy is commonest cause of Disability in India and south East Asia. This Study is devised to quantify the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose)study enrolment duration 36 months sample size 100 patients should be treated (above 15 years of age) with cerebral palsy, in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern as per as various clinical scales and also changes in the brain.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Intra thecal transplantation of autologous stem cell \[MNCs \]Per dose at the interval
Chaitanya Hospital
Pune, Maharashtra, India
RECRUITINGImprovement in muscle rigidity using Ash worth scale
Time frame: 6 Months
Improvement in dysregulated phospholipid Metabolism
Time frame: 6 months
Improvement in walking ability and kinetic gait Pattern
Time frame: 6 Months
Improvement in overall motor control using oxford scale
Time frame: 6 Months
Improvement in orbitoFrontal-amygdala circuit and self-regulation of social -emotional behaviour
Time frame: 6 month
Improvement in motor-linked implicit learning
Time frame: 6 month
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