| CTRI Number |
CTRI/2009/091/000667 [Registered on: 28/08/2009] |
| Last Modified On: |
25/08/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Stem Cell Therapy |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
To evaluate the safety and efficacy of R-HSC-001 in patients with
Parkinsons Disease (Neurological disease) |
Scientific Title of Study
Modification(s)
|
Prospective open-labeled clinical study to evaluate the safety and efficacy of R-HSC-001 in patients with Parkinsons Disease. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| RLS/HSC/2007/01 Version 03, Dated: 19/11/08 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Chandra Viswanathan |
| Designation |
Senior Vice President |
| Affiliation |
Reliance Life Sciences Pvt. Ltd., |
| Address |
Dhirubhai Ambani Life Sciences Centre
R-282, TTC Area of MIDC,
Thane Belapur Road, Rabale,
Navi Mumbai
Thane
MAHARASHTRA
400 701
India |
| Phone |
022-40678352 |
| Fax |
022-40678099 |
| Email |
chandra.viswanathan@ril.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Chandra Viswanathan |
| Designation |
Senior Vice President |
| Affiliation |
Reliance Life Sciences Pvt. Ltd. |
| Address |
Reliance Life Science Pvt. Ltd., Dhirubhai Ambani Life Sciences Centre, Plot No. R-282, TTC Area of MIDC, Rabale
Thane
MAHARASHTRA
400701
India |
| Phone |
02240678352 |
| Fax |
02240678099 |
| Email |
chandra.viswanathan@ril.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Chandra Viswanathan |
| Designation |
Senior Vice President |
| Affiliation |
Reliance Life Sciences Pvt.Ltd |
| Address |
Reliance Life Science Pvt. Ltd., Dhirubhai Ambani Life Sciences Centre, Plot No. R-282, TTC Area of MIDC, Rabale
Thane
MAHARASHTRA
400701
India |
| Phone |
02240678352 |
| Fax |
02240678099 |
| Email |
chandra.viswanathan@ril.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Reliance Life Sciences Pvt. Ltd. Dhirubhai Ambani Life Sciences Center
Thane Belapur Road, Rabale
Navi Mumbai-400701,
INDIA
|
|
Primary Sponsor
Modification(s)
|
| Name |
Reliance Life Science Pvt Ltd |
| Address |
Dhirubhai Ambani Life Sciences Centre, Plot No. R-282, TTC Area of MIDC, Rabale |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Applicable |
Relaince life Sciences,
Dhirubhai Ambani Life Sciences Center
Thane Belapur Road, Rabale
Navi Mumbai-400701,
INDIA
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madhuri Behari Prof and Head department of Neurology |
All Institute of Medical Sciences (AIIMS). |
Neurosciences Center, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110 029
New Delhi
DELHI |
01126594856
01126588166
madhuribehari@hotmail.com |
| Dr Samsher Dwidevi Senior Consultant Neurology |
Vidhyasagar Institute of Mental Health & neurosciences (VIMHANS). |
Institutional area, Nehru Nagar,-110065
New Delhi
DELHI |
01129849010
sdclinical@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS |
Approved |
| Institutional Ethics Committee, VIMHANS |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Parkinsons Disease, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
R-HSC-001 |
One time bilateral injection in brain by steriotactic surgery |
|
Inclusion Criteria
Modification(s)
|
| Age From |
35.00 Day(s) |
| Age To |
75.00 Day(s) |
| Gender |
Both |
| Details |
1. Male and female of between 35 to 75 years of age.
2. Patients with current diagnosis of PD.
3. Patients with at least 5 years since the disease.
4. Patient is able to comply with and understand the required visit schedule and required tests and procedures. |
|
| ExclusionCriteria |
| Details |
1. History of intracranial surgery.
2. History of malignancy.
3. Contraindication of MRI.
4. Significant coagnitive impairement.
5. Any contraindication to surgery.
6. Abnormal hematology and biochemistry.
7. Positive test result of HBsAg, HCV and HIV.
8. Pregnant and lactating mother. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Case Record Numbers |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change in UPDRS score |
Decrease in UPDRS score at 6 month post treatment |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To assess the safety of R-HSC-001 in patients with Parkinsons Disease |
•Treatment emergent adverse effects
•Improvement in Cognitive assessments
•Dyskinesia and Dystonia rating
•Quality of Life assessment.
•Decrease in the dose of L-dopa of Parkinsons disease
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
Modification(s)
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
09/02/2009 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
no publications done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Mesenchymal stem cells (MSCs) have been proposed as good candidates for cell replacement therapy for neurodegenerative diseases .This study is a prospective, open label multicentric clinical trial.The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow derived MSCs i.e. R-HSC-001 in patients with Parkinson’s Disease. Total 10 patients will be enrolled across the centers in India. Approximately 5-30 million cells per patient will be administered in equal proportion bilaterally in the putamen by MRI guided stereotactic surgery. Efficacy outcome will be assessded by change in UPDRS score at 1, 3, 6 and 12 month after IP administration. The safety will be assessed by recording all treatment emergent adverse events during the study period. |