| CTRI Number |
CTRI/2010/091/001469 [Registered on: 11/01/2011] |
| Last Modified On: |
21/05/2011 |
| 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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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) |
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Scientific Title of Study
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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) |
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Secondary IDs if Any
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| Secondary ID |
Registry |
| CFINTL/HB/CT-II/III/020/14-2010 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Himanshu Bansal |
| Address |
Anupam Hospital
Kashipur Road
Not Applicable
N/A
263153
India |
| Phone |
05944-243891 |
| Fax |
|
| Email |
bansal.drhimanshu@gmail.com |
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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 |
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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 |
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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 |
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Primary Sponsor
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| Name |
Dr. Himanshu Bansal Foundation |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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| Name |
Address |
| ClinFOX International |
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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 = 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
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+91-8126604942
dr.anupama.bansal@gmail.com |
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Details of Ethics Committee
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| 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 |
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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 with complete Spinal Cord Injury full filling ASIA level A Scale |
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Intervention / Comparator Agent
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| 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 |
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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 |
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
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| 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
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Method of Generating Random Sequence
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Stratified randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Safety:  To Establish Safety Of Stem Cell Therapy In Patients With Complete Spinal Cord Injury  Incidence And Severity Of Adverse Events (Assessed Clinically And By Laboratory Assessments) Efficacy:  Clinical Improvement In The Neurological Function, Functional Capacity By ASIA Level A Score  Clinical Improvement In The Sensory Functions By SSEP/SEPs (Somatosensory Evoked Potential )  Clinical Improvement In Bladder Function By Urodynamic Studies |
1.5 Years |
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Secondary Outcome
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| Outcome |
TimePoints |
|  Evaluation of the changes in the neurological functions via different route of administration
 Measurable improvement in the performance of Activities of Daily Living (ADL) using Spinal Cord Independence Measure (SCIM) Score
 Spasticity (using Modified Ashworth Scale (MAS))
 Reduction in the use of Medicines.
 Changes in Spinal MRI Finding
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2 Years |
|
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Target Sample Size
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Total Sample Size="100"
Sample Size from India="" |
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Phase of Trial
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Phase 2/ Phase 3 |
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Date of First Enrollment (India)
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No Date Specified |
| Date of First Enrollment (Global) |
09/02/2011 |
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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 |
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Publication Details
|
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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. |
