Ataxic Infantile Cerebral Palsy
Conditions
Keywords
Ataxic Infantile Cerebral Palsy stem cell therapy
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALstem cell (MNCs )
Intra thecal transplantation of autologous stem cell \[MNCs \]Per dose at the interval
Sponsors
Chaitanya Hospital, Pune
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject aged above 15 years with a diagnosis of Cerebral Palsy. Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI) * Patient suffer from cerebral palsy due to prenatal and postnatal cause, * Willing to undergoing Bone Marrow derived autologous stem cell therapy. * Able to Comprehend and give written informed consent form for the study * willing to come to the hospital for follow up visits as per the protocol requirements
Exclusion criteria
* History of meningitis,meningoencephalitis , epilepsy or life threatening allergic or immune -mediated reaction * Hemodynamically unstable patients * history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome * peripheral Muscular dystrophy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in muscle rigidity using Ash worth scale | 6 Months |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in dysregulated phospholipid Metabolism | 6 months |
| Improvement in walking ability and kinetic gait Pattern | 6 Months |
| Improvement in overall motor control using oxford scale | 6 Months |
| Improvement in orbitoFrontal-amygdala circuit and self-regulation of social -emotional behaviour | 6 month |
| Improvement in motor-linked implicit learning | 6 month |
Countries
India
Contacts
Primary ContactSachin S Jamadar, Dortho
Outcome results
None listed