| CTRI Number |
CTRI/2013/10/004109 [Registered on: 29/10/2013] Trial Registered Retrospectively |
| Last Modified On: |
17/12/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Stem Cell Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of Chronic Paraplegia
|
|
Scientific Title of Study
|
A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of Chronic Paraplegia
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CSCC/BMC.P/2011/01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anant Bagul |
| Designation |
Principal Investigator |
| Affiliation |
Chaitanya Hospital and NURSING HOME |
| Address |
Chaitanya HospitalRahi-sakha Apartment133 SINHGAD ROAD PARVATI
Chaitanya HospitalRahi-sakha Apartment133 SINHGAD ROAD PARVATI
Pune
MAHARASHTRA
411009
India |
| Phone |
08087799091 |
| Fax |
02024329666 |
| Email |
anantbagul@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anant Bagul |
| Designation |
Principle Investigator |
| Affiliation |
Chaitanya Hospital and NURSING HOME |
| Address |
Chaitanya HospitalRahi-sakha Apartment133 SINHGAD ROAD PARVATI
Chaitanya HospitalRahi-sakha Apartment133 SINHGAD ROAD PARVATI
Pune
MAHARASHTRA
411009
India |
| Phone |
08087799091 |
| Fax |
02024329666 |
| Email |
anantbagul@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sachin jamadar |
| Designation |
Sub Investigator |
| Affiliation |
Chaitanya Hospital and NURSING HOME |
| Address |
Chaitanya HospitalRahi-sakha Apartment133 SINHGAD ROAD PARVATI
Chaitanya HospitalRahi-sakha Apartment133 SINHGAD ROAD PARVATI
Pune
MAHARASHTRA
411009
India |
| Phone |
08087799091 |
| Fax |
02024329666 |
| Email |
sachinjamadar82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaitanya Vaidyakeeya Seva Sanstha, 44/2 Hill View Society, Paud Phata, Paud Road, Pune 411029,M.S. , INDIA (Its A Registered Charitable Trust Organisation, Which Funds Various Social And Medical Activities) |
|
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Primary Sponsor
|
| Name |
Arvind Bagul |
| Address |
44/2 Hill view society, paudh road , Pune |
| Type of Sponsor |
Other [Trust] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Anant Bagul |
Chaitanya Hospital, Parvati, Pune |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anant bagul |
Chaitanya Hospital and Nursing Home |
Chaitanya hospital,Rahi sakha apartment 133 SINHGAD ROAD PARVATI PUNE 411009
Pune
MAHARASHTRA |
08087799091
02024308366
anantbagul@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chaitanya Vaidyakeeya Seva Sanstha |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Paraplegia., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intra Thecal transplantation of Autologous Stem cells |
100 millions MNC per dose in 3 divided doses in span of 30 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Should suffer from Chronic Paraplegia due to pyramidal or extra-pyramidal cause.
Willingness to undergo Bone marrow derived Autologous cell therapy.
Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
Ability and willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.
|
|
| ExclusionCriteria |
| Details |
Patients with pre-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis A) gastrointestinal , cardiac, immunodeficiency (including HIV) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc.
History of life threatening allergic or immune-mediated reaction.
Haemodynamically unstable subjects.
Subjects suffering from peripheral muscular dystrophy.
Severe skin infection and osteomyelitis/ or at the site of bone marrow aspiration potentially limiting the procedure.
Positive test results for Hepatitis A and Hepatitis B or C.
Alcohol and / or drug abuse/ dependence.
Subjects with primary or secondary diabetes, insulin dependence or with serum creatinine > 1.5 mg/dL.
Neurological disease caused by autoimmune or genetic cause. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in overall sensory for motor control using Frankel score. - Improvement in sensory and motor dysfunction using ASIA scale (American spinal cord injury association) |
6 weeks,3,6,9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in bowel and bladder control |
3,6,9 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2011 |
| 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
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Data will be presented in conferences,seminars & in journals. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a single arm, single center trial to check active comparing the safety and efficacy of Bone marrow derived autologous cells (100 million per dose). Trial to be conducted for 36 months in 100 patients with Chronic Paraplegia in India. Primary outcome measures are Improvement in overall sensory for motor control using Frankel score. |