None listed
Conditions
Interventions
Intervention1: single injection using precoronal burr hole surgery: 4 million cells/kg body weight.
Control Intervention1: NIL: NIL
Sponsors
ADVANCED NEURO-SCIENCE ALLIES PVT. LTD
#560, Bhargavi, 9th "A" Main, Indiranagar,
Bangalore-560 038
Karnataka (INDIA)
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion of patients for therapy will be under the investigator's discretion. However the following criteria will be considered. 1. Should be in the age group of 18-80 years. 2. Should be fully conscious, alert and oriented while providing consent 3. Should show significant motor and non motor symptoms 4. Subject should understand the requirements of study 5. Subject should provide a written informed consent and agree to return for Follow up 6. Subject should be clinically diagnosed for Parkinson's disease with motor complications despite adequate oral anti-parkisonian therapy. 7. Should be able to comply with and understand the required visit schedule and complete the same.
Exclusion criteria
Exclusion criteria: Exclusion of patients from therapy will be under the investigator's discretion. However the following criteria will be considered 1. Patient is suffering from Dementia (MMSE <25) 2. Patient is suffering from a neurodegenerative disorder other than Parkinson. 3. The extent or severity of the disease is not measurable. 4. If the subject suffers from pre-existing medical conditions such as bleeding disorders, septicemia. 5. Patients with a past (within one year) or present history of psychiatric disorder. 6. If the subject has been enrolled in other investigational drug trial or has completed any trial within the last 3 months. 7. If Hemoglobin < 10gm/dl, Serum Creatinine< 2mg/dl serum total bilirubin< 2mg /dl and HbA1c<7? 8. Pregnant or nursing or women in child bearing age without adequate contraception. 9. The subject tested positive for HIV, HCV, HBV,or VDRL
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome will be the change in the baseline in UPDRS. Timepoint: 3,6,9,12 months | — |
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome measures: 1 At 1, 3, 6 and 12 months after discharge, patients will have follow-up examinations to assess their clinical status and to review their current medication. 2 Clinical improvement will be defined as a decrease in the specific symptom and lesions. 3 UPDRS will be repeated in all patients. Apart from the routine Proforma for Parkinsonism, the UPDRS will be done at the baseline and at the 12th month. 4 Safety and tolerability, assessed by adverse events 5 Quality of life Timepoint: 3,6,9,12 months | — |
Countries
India
Contacts
Public ContactMrs. Vijaylakshmi A
Outcome results
None listed