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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STEM CELL | Other | Transfer of autologous stem cell [MNCs ]intrathecally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stem cell (MNCs ) | Biological | Intra thecal transplantation of autologous stem cell [MNCs ]Per dose at the interval |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in muscle rigidity using Ash worth scale | 6 Months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sachin S Jamadar, Dortho | Contact | +918888788880 | sac2751982@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| ANANT E BAGUL, M.S | CHAITANYA HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaitanya Hospital | Recruiting | Pune | Maharashtra | 411009 | India |
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| ID | Term |
|---|---|
| C562856 | Cerebral Palsy, Ataxic, Autosomal Recessive |
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| 6 Months |
| Improvement in orbitoFrontal-amygdala circuit and self-regulation of social -emotional behaviour | 6 month |
| Improvement in motor-linked implicit learning | 6 month |