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CTRI Number  CTRI/2010/091/001469 [Registered on: 11/01/2011]
Last Modified On: 21/05/2011
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Other 
Public Title of Study   A Clinical Trial to study the safety & effectiveness of Adult Stem Cells derived from Bone Marrow via different routes of administration in the treatment of patients with complete Spinal Cord Injury (SCI)  
Scientific Title of Study   AN OPEN LABEL, RANDOMIZED, MULTICENTRIC, PROSPECTIVE, CLINICAL STUDY TO DETERMINE THE SAFETY AND THEREPEUTIC EFFECTIVENESS OF BONE MARRROW DERIVED ADULT STEM CELLS VIA MULTIPLE ROUTES OF ADMINSTRATION IN THE TREATMENT OF PATIENTS WITH COMPLETE SPINAL CORD INJURY (SCI) 
Secondary IDs if Any  
Secondary ID  Registry 
CFINTL/HB/CT-II/III/020/14-2010  Protocol Number 
 
Details of Principal Investigator  
Name  Dr. Himanshu Bansal 
Address  Anupam Hospital
Kashipur Road
Not Applicable
N/A
263153
India 
Phone  05944-243891  
Fax    
Email  bansal.drhimanshu@gmail.com  
 
Details Contact Person
Scientific Query
 
Name  Dr. Himanshu Bansal 
Address  Anupam Hospital
Kashipur Road
Not Applicable
N/A
263153
India 
Phone  05944-243891  
Fax    
Email  bansal.drhimanshu@gmail.com  
 
Details Contact Person
Public Query
 
Name  Sreedhar Singamala 
Address  Office 14 & 15, First Floor,Soni Business Complex,Prashanthi Nagar

Hyderabad
ANDHRA PRADESH
500072
India 
Phone  040-64545858  
Fax    
Email  sreedhar@clinfoxintl.com  
 
Source of Monetary or Material Support  
ClinFOX International Office 14&15, 1st Floor, Soni Business Complex, Prashanthi Nagar, Kukatpally, Hyderabad-500 072 (India) Phones:040-64545858,64585860 
 
Primary Sponsor  
Name  Dr. Himanshu Bansal Foundation 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
ClinFOX International   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr.OP Mahajan  Anupam Hospital  Department of Orthopaedic Surgery,-263153
Not Applicable
 
05944243891

dr.mahajan.op@gmail.com 
Dr. Himanshu Bansal  KS Hospitals  # 747 Poonamallee High Road,Kilpauk-600010
Chennai
 
044-26412326

bansal.drhimanshu@gmail.com 
Dr. Anupama Bansal  Nurture Hospitals   C-125,NARAINA VIHAR-110028
New Delhi
 
+91-8126604942

dr.anupama.bansal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Anupam Hospital-Independent Ethics Committee  Approved 
KS Hospitals-Independent Ethics Committee  Approved 
Nurture Hospitals-Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
  Patients with complete Spinal Cord Injury full filling ASIA level A Scale 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bone Marrow derived Adult Stem Cells   20 ml of Achieved concentrate from 120ml of aspirate adult stem cells  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  1. Be a Male/Female of ages 18 to 65 years 2. Who is properly informed of the nature and risks of the clinical study, who is willing and capable of complying with all clinical study procedures, and has given informed consent in writing prior to entering the clinical study. Subjects who are willing to comply with the study procedure. 3. Be with complete spinal cord injury (ASIA level A) 4. Time between injury and enrollment is greater than or equal 1 month and less than or equal to 1 year 5. Have Platelet count > 100 Thousand/µL at screening 6. Have White Blood Count < 15,000 7. International Normalized Ratio (INR) less than or equal to 1.5 8. Hematocrit < 30% prior to bone marrow aspiration 9. Have the neurological level is between C5 and T10 10. Have complete or partial transaction/damage as shown by MRI  
 
ExclusionCriteria 
Details  x. Ongoing Alcohol/ Substance Abuse. x. Intoxication, Intubation, Sedation and Immobilization x.Osteoporosis or low bone mass as determined by medical history or DXA x. Cancer over last 3 years prior to enrollment x. Presence of a primary Hematological disease or any coagulation abnormalities or concomitant treatment with coumarin anti-coagulant x. Implanted Medical Devices like Cardiac Stents, Pace Makers, Bladder Stimulators and Permanent modification of Anatomy x. Uncontrolled Diabetes, Hypertension, Auto Immune Disease, Psychiatric illness, terminal Renal Failure with existing dependence on dialysis and history of Bone Marrow diseases x. Possibility of non-compliance with the protocol. x. Subjects with Syringomyelia, Spinal Stenosis, Plexopathy, Neuropathy, Radiculopathy, Cauda Equina Injury, Myelitis, Demyelination, Ischemia, Severe Spinal Degenerative Pathologies, Ongoing Focal Spinal Cord Compression or anatomically complete lesions x.Longitudinal dimension of injury more than 3 segments x. Women who is pregnant or nursing or of child-bearing potential unwilling to use effective barrier method of contraception for the duration of the study x.No informed consent. x. Signs of Meningitis with Fever (above 39°C) x. Coma or other severe injury or disease x. Penetrating injury x. Unsuitable based on MRI or other factor x. Subjects who have taken Immunosuppressant?s within the last one month  
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Safety: &#61692; To Establish Safety Of Stem Cell Therapy In Patients With Complete Spinal Cord Injury &#61692; Incidence And Severity Of Adverse Events (Assessed Clinically And By Laboratory Assessments) Efficacy: &#61692; Clinical Improvement In The Neurological Function, Functional Capacity By ASIA Level A Score &#61692; Clinical Improvement In The Sensory Functions By SSEP/SEPs (Somatosensory Evoked Potential ) &#61692; Clinical Improvement In Bladder Function By Urodynamic Studies  1.5 Years 
 
Secondary Outcome  
Outcome  TimePoints 
&#61656; Evaluation of the changes in the neurological functions via different route of administration &#61656; Measurable improvement in the performance of Activities of Daily Living (ADL) using Spinal Cord Independence Measure (SCIM) Score &#61656; Spasticity (using Modified Ashworth Scale (MAS)) &#61656; Reduction in the use of Medicines. &#61656; Changes in Spinal MRI Finding   2 Years 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   No Date Specified 
Date of First Enrollment (Global)  09/02/2011 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Brief Summary   This study is an open label, randomized, multi centric trial comparing the safety and efficacy via different routes of administration (intrathecal, intravenous, direct) of bone marrow derived adult stem cells in patients with complete spinal cord injury in about 100 patients. In this study, subjects fulfilling the inclusion criteria will be enrolled in the study by taking the ICD, followed by randomization. Bone marrow derived adult stem cells derived from bone marrow aspirate will be administered either intrathecally below the site of lesion, intravenously or directly at the site of lesion. Efficacy will be assessed by clinical assessment of neurological and urinary bladder functions. Safety will be assessed throughout the study. 

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