FULL DETAILS (Read-only)

CTRI Number  CTRI/2013/10/004099 [Registered on: 25/10/2013] Trial Registered Prospectively
Last Modified On: 17/12/2014
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)  
A clinical trial to study the safety and efficacy of Bone marrow derived autologous cells for the treatment of Acute Paraplegia 
Scientific Title of Study
Modification(s)  
A clinical trial to study the safety and efficacy of Bone marrow derived autologous cells for the treatment of Acute Paraplegia 
Secondary IDs if Any
Modification(s)  
Secondary ID  Registry 
CSCC/BMAP/2011/01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Anant Bagul 
Address  Chaitanya hospital,rahi sakha apartment 133 sinhgad road parvati pune
Chaitanya hospital,rahi sakha apartment 133sinhgad road parvati pune
Pune
MAHARASHTRA
411009
India 
Phone  08087799091  
Fax  02024329666  
Email  anantbagul@yahoo.com  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Dr sachin jamadar  
Address  Chaitanya hospital Rahi sakha apartment 133 sinhgad road parvati pune
Chaitanya hospital Rahi sakha apartment 133 sinhgad road parvati pune
Pune
MAHARASHTRA
411009
India 
Phone  08087799091  
Fax  02024329666  
Email  sachinjamadar82@gmail.com  
 
Details Contact Person
Public Query

Modification(s)  
Name  Dr sachin jamadar  
Address  Chaitanya hospitalRahi sakha apartment133 sinhgad road parvati pune
Chaitanya hospitalRahi sakha apartment133 sinhgad road parvati pune
Pune
MAHARASHTRA
411009
India 
Phone  08087799091  
Fax  02024329666  
Email  sachinjamadar82@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
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) 
 
Primary Sponsor
Modification(s)  
Name  Chaitanya Vaidyakiya seva sanstha 
Address  44/2 hill view society, paudh phata, paudh road pune. 
Type of Sponsor  Other [Trust] 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Dr Anant Bagul  133 Parvati, Pune 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Anant Bagul  Chaitanya Hospital  Chaitanya hospital,Rahi sakha apartment-411030
Pune
 
02024318600
02024308366
anantbagul@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chaitanya Vaidyakeeya Seva Sanstha   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Acute paraplegia  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Intra Thecal transplantation of Autologous Stem cells  100 millions MNC per dose in 3 divided doses at interval of 7 days in 30 days total duration of therapy will be 30 days  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria
Modification(s)  
Age From  3.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Should suffer from Acute 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
 
 
Method of Generating Random Sequence
Modification(s)  
Not Applicable 
Method of Concealment
Modification(s)  
Not Applicable 
Blinding/Masking
Modification(s)  
Not Applicable 
Primary Outcome
Modification(s)  
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, 9 & 12 months 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
- Improvement in bowel and bladder control.  6 months 
 
Target Sample Size
Modification(s)  
Total Sample Size="100"
Sample Size from India="100" 
Phase of Trial
Modification(s)  
Phase 2/ Phase 3 
Date of First Enrollment (India)
Modification(s)  
30/10/2013 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial
Modification(s)  
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
Modification(s)  
Will sort for national as well as international publications. 
Brief Summary
Modification(s)  
This study is a single arm, single center trial to check the safety and efficacy of bone marrow derived autologous mononuclear cells (100 million per dose) Trial to be conducted for 36 months in 100 patients with Acute Paraplegia, primary outcome measures include Improvement in overall sensory for motor control using Frankel score. 

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
Modification(s)  
Stem Cell Therapy 
Study Design  Single Arm Study 
Public Title of Study
Modification(s)  
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
Modification(s)  
A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of Chronic Paraplegia  
Secondary IDs if Any
Modification(s)  
Secondary ID  Registry 
CSCC/BMC.P/2011/01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Anant Bagul 
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 Contact Person
Scientific Query

Modification(s)  
Name  Dr Anant Bagul 
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 Contact Person
Public Query

Modification(s)  
Name  Dr sachin jamadar  
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
Modification(s)  
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) 
 
Primary Sponsor
Modification(s)  
Name  Arvind Bagul 
Address  44/2 Hill view society, paudh road , Pune 
Type of Sponsor  Other [Trust] 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Anant Bagul  Chaitanya Hospital, Parvati, Pune 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Contact Person  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
 
08087799091
02024308366
anantbagul@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chaitanya Vaidyakeeya Seva Sanstha   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Chronic Paraplegia. 
 
Intervention / Comparator Agent
Modification(s)  
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
Modification(s)  
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. 
 
Method of Generating Random Sequence
Modification(s)  
Not Applicable 
Method of Concealment
Modification(s)  
Not Applicable 
Blinding/Masking
Modification(s)  
Not Applicable 
Primary Outcome
Modification(s)  
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
Modification(s)  
Outcome  TimePoints 
Improvement in bowel and bladder control   3,6,9 months 
 
Target Sample Size
Modification(s)  
Total Sample Size="100"
Sample Size from India="100" 
Phase of Trial
Modification(s)  
Phase 2/ Phase 3 
Date of First Enrollment (India)
Modification(s)  
01/03/2011 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial
Modification(s)  
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
Modification(s)  
Data will be presented in conferences,seminars & in journals.  
Brief Summary
Modification(s)  
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. 

CTRI Number  CTRI/2011/091/000159 [Registered on: 15/02/2011]
Last Modified On: 12/12/2014
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)  
A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of cerebral palsy in subjects above 15 years. 
Scientific Title of Study
Modification(s)  
A clinical trial to study the safety and efficacy of Bone marrow derived Autologous stem cells for the treatment of cerebral palsy in subjects above 15 years. 
Secondary IDs if Any
Modification(s)  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Anant Bagul 
Address  Chaitanya Hospital,
Rahi-sakha Apartment
Pune
MAHARASHTRA
411030
India 
Phone  02024328600  
Fax  02024329666  
Email  anantbagul@yahoo.com  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Anant Bagul 
Address  Chaitanya Hospital,
Rahi-sakha Apartment
Pune
MAHARASHTRA
411030
India 
Phone  8087799091  
Fax  02024329666  
Email  anantbagul@yahoo.com  
 
Details Contact Person
Public Query

Modification(s)  
Name  Anant Bagul 
Address  Chaitanya Hospital,
Rahi-sakha Apartment
Pune
MAHARASHTRA
411030
India 
Phone  8087799092  
Fax  02024329666  
Email  anantbagul@yahoo.com  
 
Source of Monetary or Material Support
Modification(s)  
Chaitanya Vaidyakeeya Seva Sanstha 
 
Primary Sponsor
Modification(s)  
Name  Chaitanya Stem Cell Center 
Address  Rahi Sakha Apt.,S.No.133, Sinhagad Road, Parvati,Pune411 030. 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Chaitanya Vaidyakeeya Seva Sanstha  Rahi Sakha Apt.,S.No.133, Pune - Sinhagad Road, Parvati,Pune - 411 030. 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Anant Bagul  Chaitanya hospital  Chaitanya hospital,Rahi sakha apartment-Pune , Maharashtra India 411030
Pune
 
02024328600
02024329666
anantbagul@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chaitanya Vaidyakeeya Seva Sanstha   Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Cerebral Palsy above 15 years 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Stem cell therapy  Bone marrow derived Autologous cells - 100 millions per dose, total of 3 doses. 
Comparator Agent  Stem cell therapy  Bone marrow derived Autologous cells - 100 millions per dose, total of 3 doses. 
 
Inclusion Criteria
Modification(s)  
Age From  3.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Should suffer from cerebral palsy due to prenatal and postnatal cause.
2. Willingness to undergoing Bone marrow derived autologous stem cell therapy
3. 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.
4. 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  1. 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. 2. History of life threatening allergic or immune-mediated reaction. 3. Haemodynamically unstable subjects. 4. Subjects suffering from peripheral muscular dystrophy. 5. Severe skin infection and osteomyelitis/ or at the site of bone marrow aspiration potentially limiting the procedure. 6. Positive test results for Hepatitis A and Hepatitis B or C. 7. Alcohol and / or drug abuse/ dependence. 8. Subjects with primary or secondary diabetes, insulin dependence or with serum creatinine > 1.5 mg/dL. 9. Neurological disease caused by autoimmune or genetic cause  
 
Method of Generating Random Sequence
Modification(s)  
Not Applicable 
Method of Concealment
Modification(s)  
Not Applicable 
Blinding/Masking
Modification(s)  
Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Improvement in muscle rigidity using Ashworth scale. - Improvement in walking ability and kinetic gait pattern - Improvement in overall motor control using oxford scale 3 months   6 months 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Improvement in dysregulated phospholipid metabolism. - Improvement in orbito-frontal-amygdala circuit and self-regulation of social-emotional behavior.. - Improvement in motor-linked implicit learning. - Reduction in burden on family  6 months 
 
Target Sample Size
Modification(s)  
Total Sample Size="100"
Sample Size from India="100" 
Phase of Trial
Modification(s)  
Phase 2/ Phase 3 
Date of First Enrollment (India)
Modification(s)  
01/03/2011 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial
Modification(s)  
Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
no 
Brief Summary
Modification(s)  
This study is a single arm, single center trial to check safety and efficacy of Bone marrow derived autologous cells (100 million per dose) . Trial to be conducted for 36 months in 100 Patients. Primary outcome measures are Improvement in walking ability and kinetic gait pattern. 

CTRI Number  CTRI/2013/10/004098 [Registered on: 25/10/2013] Trial Registered Prospectively
Last Modified On: 17/12/2014
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)  
A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of cerebral palsy in subjects below 15 years. 
Scientific Title of Study
Modification(s)  
A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of cerebral palsy in subjects below 15 years. 
Secondary IDs if Any
Modification(s)  
Secondary ID  Registry 
CSCC/BMCP2/2011/01  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Anant Bagul 
Address  Chaitanya Hospital Rahi Sakha Apartment 133 sinhgad road parvati pune
Chaitanya Hospital Rahi Sakha Apartment 133 sinhgad road parvati pune
Pune
MAHARASHTRA
411009
India 
Phone  08087799091  
Fax  02024329666  
Email  anantbagul@yahoo.com  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Dr Anant Bagul 
Address  Chaitanya Hospital Rahi Sakha apartment 133 sinhgad road parvati pune
Chaitanya Hospital Rahi Sakha apartment 133 sinhgad road parvati pune
Pune
MAHARASHTRA
411009
India 
Phone  08087799091  
Fax  02024329666  
Email  anantbagul@yahoo.com  
 
Details Contact Person
Public Query

Modification(s)  
Name  Dr sachin jamadar  
Address  Chaitanya Hospital Rahi Sakha apartment 133 sinhgad road parvati pune
Chaitanya Hospital Rahi Sakha apartment 133 sinhgad road parvati pune
Pune
MAHARASHTRA
411009
India 
Phone  08087799091  
Fax  02024329666  
Email  sachinjamadar82@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
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) 
 
Primary Sponsor
Modification(s)  
Name  Arvind Bagul 
Address  44/2 Hill view society, Paudh road, Pune 
Type of Sponsor  Other [Trust] 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Dr Anant Bagul  Rahi sakha appartment, parvati paitha, Pune. 
 
Countries of Recruitment
Modification(s)  
  India  
Sites of Study
Modification(s)  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Anant Bagul  Chaitanya Hospital  Chaitanya hospital,Rahi sakha apartment-411030
Pune
 
02024328600
02024308366
anantbagul@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chaitanya Vaidyakeeya Seva Sanstha   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Cerebral Palsy below 15 years. 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Intra Thecal transplantation of Autologous Stem cells  100 millions MNC per dose in 3 divided doses at interval of 10 days in total duration of 30 days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria
Modification(s)  
Age From  3.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. Subjects aged above 3 years and below 15 years with a diagnosis of Cerebral Palsy.
2. Regional nerve damage as shown by Magnetic Resonance Imaging (MRI)
3. Able to comprehend and give informed consent for the study and willing to come to the hospital for follow up visits as per the protocol requirements (patient or his legal guardian).
 
 
ExclusionCriteria 
Details  1. History of meningitis, meningoencephalitis, epilepsy or life ?threatening allergic or immune-mediated reaction 2. Hemodynamically unstable patients 3. History of or concurrent autoimmune disease or an acute episode of Guillain-barre syndrome 4. Peripheral muscular dystrophy  
 
Method of Generating Random Sequence
Modification(s)  
Not Applicable 
Method of Concealment
Modification(s)  
Not Applicable 
Blinding/Masking
Modification(s)  
Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Improvement in muscle rigidity using Ashworth scale. - Improvement in walking ability and kinetic gait pattern - Improvement in overall motor control using oxford scale. 3 months   6 weeks,3,6,9 months 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Improvement in IQ by using Benit Kamat scale - Improvement in social behavior - Reduction in irritability. - Reduction in deformity   3,6,9&12 months 
 
Target Sample Size
Modification(s)  
Total Sample Size="100"
Sample Size from India="100" 
Phase of Trial
Modification(s)  
Phase 2/ Phase 3 
Date of First Enrollment (India)
Modification(s)  
30/10/2013 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial
Modification(s)  
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
Modification(s)  
Study data will be presented at various conferences , seminars and Journels 
Brief Summary
Modification(s)  
This study is a single arm, single center trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells (100 million per dose) Trial to be conducted for 36 months in 100 patients (below 15 yrs of age) with cerebral palsy in India. Primary outcome measures are Improvement in walking ability and kinetic gait pattern. 

CTRI Number  CTRI/2013/10/004105 [Registered on: 28/10/2013] Trial Registered Prospectively
Last Modified On: 17/12/2014
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)  
A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of stroke. 
Scientific Title of Study
Modification(s)  
A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of stroke. 
Secondary IDs if Any
Modification(s)  
Secondary ID  Registry 
CSCC/BMS/2011/01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Anant Bagul 
Address  Chaitanya Hospital Rahi Sakha appartment 133 sinhgad road parvati pune
Chaitanya Hospital Rahi Sakha appartment 133 sinhgad road parvati pune
Pune
MAHARASHTRA
411009
India 
Phone  08087799091  
Fax  02024329666  
Email  anantbagul@yahoo.com  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Dr Anant Bagul 
Address  Chaitanya Hospital Rahi sakha apt 133 sinhgad road parvati pune
Chaitanya Hospital Rahi sakha apt 133 sinhgad road parvati pune
Pune
MAHARASHTRA
411009
India 
Phone  08087799091  
Fax  02024329666  
Email  anantbagul@yahoo.com  
 
Details Contact Person
Public Query

Modification(s)  
Name  Dr sachin jamadar  
Address  Rahi sakha apt 133 sinhGAD ROAD PARVATI PUNE
Rahi sakha apt 133 sinhGAD ROAD PARVATI PUNE
Pune
MAHARASHTRA
411009
India 
Phone  08087799091  
Fax  02024329666  
Email  sachinjamadar82@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
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) 
 
Primary Sponsor
Modification(s)  
Name  Arivind Bagul 
Address  44/2 Hill view society , Paudh Road, Pune 
Type of Sponsor  Other [Trust] 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Anant Bagul  Chaitanya Hospital, Parvati, Pune 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Ananat Bagul   Chaitanya Hospital and Nursing Home  Rahi sakha apartment 133 sinhgad road parvati
Pune
 
08087799091
02024329666
anantbagul@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chaitanya Vaidyakeeya Seva Sanstha   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Stroke - Cerebral Hemiplegia 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Intra Thecal transplantation of Autologous Stem cells  100 millions MNC per dose in 3 divided doses at interval of 10 days in stem cell therapy in total duration of 30 days  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Should suffer from stroke due to cerebral infarct or haemorrhage or accelerated hyper tension.

2.Willingness to undergo Autologous Stem Cell Therapy

3.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.

4.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  1.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.

2.History of life threatening allergic or immune-mediated reaction.

3. Haemodynamically unstable subjects.

4.Subjects suffering from peripheral muscular dystrophy.

5.Severe skin infection and osteomyelitis/ or at the site of bone marrow aspiration potentially limiting the procedure.

6.Positive test results for Hepatitis A and Hepatitis B or C.

7.Alcohol and / or drug abuse/ dependence.

8.Subjects with primary or secondary diabetes, insulin dependence or with serum creatinine > 1.5 mg/dL.

9.Neurological disease caused by autoimmune or genetic cause.


 
 
Method of Generating Random Sequence
Modification(s)  
Not Applicable 
Method of Concealment
Modification(s)  
Not Applicable 
Blinding/Masking
Modification(s)  
Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Improvement in power of Body and facial Muscles  3, 6, 9 months
 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Improvement In Walking Ability Improvement In Speech And Cognition. Improvement In Vision In Both Eyes.  3,6 & 9 Months 
 
Target Sample Size
Modification(s)  
Total Sample Size="100"
Sample Size from India="100" 
Phase of Trial
Modification(s)  
Phase 2/ Phase 3 
Date of First Enrollment (India)
Modification(s)  
29/10/2013 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial
Modification(s)  
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
Modification(s)  
The data obtained from the trial will be published & presented in Conferences and journals. 
Brief Summary
Modification(s)  
This study is a single arm , single center trail for check the safety and efficacy of bone marrow derived autologous mononuclear cells (100 million per dose) Trial to be conducted for 36 months in 100 stroke Patients The Primary outcome measure will be Improvement in muscle power of Body and face 

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