Clinical study on the use of ex vivo expanded allogeneic mesenchymal stem cells for Parkinson's disease
- Registration Number
- CTRI/2010/091/000432
- Lead Sponsor
- ADVANCED NEURO-SCIENCE ALLIES PVT. LTD#560, Bhargavi, 9th "A" Main, Indiranagar, Bangalore-560 038Karnataka (INDIA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 15
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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome measures:<br>1At 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. <br>2Clinical improvement will be defined as a decrease in the specific symptom and lesions. <br>3UPDRS 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.<br>4Safety and tolerability, assessed by adverse events<br>5Quality of life<br><br>Timepoint: 3,6,9,12 months
- Secondary Outcome Measures
Name Time Method Secondary Outcome will be the change in the baseline in UPDRS. <br><br><br>Timepoint: 3,6,9,12 months