| CTRI Number |
CTRI/2010/091/000432 [Registered on: 04/10/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Other |
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Public Title of Study
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Clinical study on the use of ex vivo expanded allogeneic mesenchymal stem cells for Parkinson's disease |
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Scientific Title of Study
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Clinical study on the use of ex vivo expanded allogeneic mesenchymal stem cells for Parkinson's disease |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| ANSA/BGSG/009/10-11 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr. N.K. VENKATARAMANA; |
| Designation |
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| Affiliation |
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| Address |
M.Ch (Neurosurgery) Director, Advanced Neuro-science Institute Vice-Chairman, BGS-Global Hospital,
BGS Health & Education City, # 67, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
+080-25289292 |
| Fax |
+080-43312299 |
| Email |
drnkvr@gmail.com |
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Details of Contact Person
Scientific Query
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| Name |
Dr. Satish Totey ;President & CEO |
| Designation |
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| Affiliation |
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| Address |
Advanced Neuro-Science Allies Pvt. Ltd #560, Bhargavi, 9th ?A? Main,
Indiranagar,
Bangalore
KARNATAKA
560038
India |
| Phone |
+91-080-43312222 |
| Fax |
+91-080-43312299 |
| Email |
satishtotey@ansaresearch.com |
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Details of Contact Person
Public Query
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| Name |
Mrs. Vijaylakshmi A |
| Designation |
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| Affiliation |
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| Address |
Advanced Neuro-Science Allies Pvt. Ltd #560, Bhargavi, 9th ?A? Main,
Indiranagar,
Bangalore
KARNATAKA
560038
India |
| Phone |
+91-080-43312222/ +91-9880811009 |
| Fax |
+91-080-43312299 |
| Email |
viji@ansaresearch.com |
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Source of Monetary or Material Support
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| ADVANCED NEURO-SCIENCE ALLIES PVT LTD, #560, "BHARGAVI", 9TH "A" MAIN, INDIRANAGAR, BANGALORE-560 038, KARNATAKA, INDIA |
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Primary Sponsor
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| Name |
ADVANCED NEURO-SCIENCE ALLIES PVT. LTD
#560, Bhargavi, 9th "A" Main, Indiranagar,
Bangalore-560 038
Karnataka (INDIA)
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| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Abhilash Bansal |
BGS-GLOBAL HOSPITAL |
BGS Health & Education City,#67, Uttarahalli Road, Kengeri,-560060
Bangalore
KARNATAKA |
+91-80-26255555
abhilashbansal@hotmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BGS Global Hospital BGS Health & Education City, # 67, Uttarahalli Road, Kengeri Bangalore-560 060 |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Parkinson's Disease, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
single injection using precoronal burr hole surgery |
4 million cells/kg body weight. |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
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.
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| ExclusionCriteria |
| Details |
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
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| 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
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3,6,9,12 months |
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Secondary Outcome
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| Outcome |
TimePoints |
| Secondary Outcome will be the change in the baseline in UPDRS.
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3,6,9,12 months |
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Target Sample Size
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Total Sample Size="15"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/01/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="2"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This study has been designed as an open label, non-randomized, uncontrolled, prospective, single center, pilot study. The subject will receive ex-vivo expanded bone marrow derived allogeneic mesenchymal stem cells at the dose of 4million cells/Kg body weight. First dose will be given through precoronal burr hole surgery after baseline studies are over.
Source of cells: The mesenchymal stem cells would be derived from the Bone marrow of an adult healthy donor after appropriate screening and informed consent.
Method of expansion:
The sample would be centrifuged and the cell suspension separated using density gradient technique to isolate the mononuclear stem cells ( MNCs) .From the MNC fraction, mesenchymal stem cells will be further isolated using plastic adhesion technique and expanded in vitro to obtain the required number of cells for intervention. The cells would be further quality tested as per ISCT (International Society for Cellular Therapy) guidelines before release for clinical intervention.
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