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This study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow Derived Autologous mononuclear cell {MNC} (100 Million per dose).trial to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are Improvement in cognitive and Psychiatric Symptoms and Improvement in Jerky,random, and Uncontrollable Movements called Chorea.
This study is Single arm, Single Centre trial study the Safety and Efficacy of Bone Marrow Derived Autologous mononuclear cells (MNCs) ,to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are Improvement in cognitive and Psychiatric Symptoms and Improvement in Jerky,random, and Uncontrollable Movements called Chorea.
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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 |
|---|---|---|---|---|
| autologous Stem Cell | Biological | Intrathecal transplantation of autologous 100 millions Stem cells{MNCs } per dose' |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Cognitive and psychiatric symptoms | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in neuropsychiatric behaviour | 6 Months | |
| Increase in life expectancy | Increase in life expectancy.Time period- 6 Months | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
Patient with History of Immunodeficiency HIV+,Hepatitis B virus ( HBV) and History of Life threatening allergic or immune -Mediated Reaction. the site of bone marrow aspiration potentially limiting Procedure.
alcohol and drug abuse / dependence.
Severe skin infection.
Haemodynamically unstable.
=subject with primary and secondary diabetes , Insulin dependence.
Neurological disease caused by autoimmune or genetic cause.
patients suffering from peripheral muscular dystrophy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sachin P Jamadar, D Ortho | Contact | +918888788880 | sac2751982@gmail.com | |
| Smita S Bhoyar, B.A.M.S.PGCR | Contact | 9372620569 | drsmitabhoyar@rediff.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 |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Improvement in writhing motions or abnormal posturing | -Improvement in writhing motions or abnormal posturing | 6 month |
| Improvement in compulsive behaviour | 6 month |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |