| CTRI Number |
CTRI/2025/07/091977 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Stem Cell Therapy
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study safety and efficacy of biomaterials in helping recovery of participants after spinal cord injury who are not able to walk |
|
Scientific Title of Study
|
Safety and efficacy of biological scaffolds in patients with spinal cord injury |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Yadav |
| Designation |
Associate Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Varanasi Deparment of Orthopedics, Faculty of Medicine, Institute of Medical Sciences, Banaras Hindu Uniersity, Uttar Pradesh, India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9560754591 |
| Fax |
|
| Email |
drsanjay.pgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ashok Kumar |
| Designation |
Professor |
| Affiliation |
Indian Institute of Technology Kanpur |
| Address |
Lab 231, Department of Biological Sciences and Bioengineering, Indian Institute of Technology Kanpur, Kalyanpur, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH
208016
India |
| Phone |
9936491834 |
| Fax |
|
| Email |
ashokkum@iitk.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Chooramani Gopal |
| Designation |
Distinguished Visiting Professor |
| Affiliation |
Indian Institute of Technology Kanpur |
| Address |
Lab 231, Department of Biological Sciences and Bioengineering, Indian Institute of Technology Kanpur, Kalyanpur, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH
208016
India |
| Phone |
7607957777 |
| Fax |
|
| Email |
sarojchooramani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Institute of Technology Kanpur, Kalyanpur, Uttar Pradesh, India- 208016 |
| Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India 221005 |
|
|
Primary Sponsor
|
| Name |
Dr Sanjay Yadav |
| Address |
Deparment of Orthopedics, Faculty of Medicine, Institute of Medical Sciences, Banaras Hindu University, Uttar Pradesh, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Institute of Medical Sciences Banaras Hindu University |
Deparment of Orthopedics, Faculty of Medicine, Institute of Medical Sciences, Banaras Hindu University, Uttar Pradesh, India |
| Prof Ashok Kumar |
Lab 231, Department of Biological Sciences and Bioengineering, Indian Institute of Technology Kanpur, Kalyanpur, Uttar Pradesh, India 208016 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Yadav |
Institute of Medical Sciences, Banaras Hindu University |
Room No 5031, Deparment of Orthopedics, 4th floor, B Wing, Trauma Center and Multispeciality Hospital, Institute of Medical Sciences, Banaras Hindu University, Uttar Pradesh, India 221005
Varanasi
UTTAR PRADESH |
9560754591
drsanjay.pgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University, Institute of Medical Sciences, Institutional Ethics Commiittee Varanasi, 221005 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G952||Other and unspecified cord compression, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
biodegradable scaffold, exosomes, autologous bone marrow concentrate |
Biodegradable scaffold implanted at the injury site, Exosomes isolated from human adipose mesenchymal stem cells (150 microgram per scaffold) and embedded in the scaffold at the time of surgery, Autologous bone marrow mononuclear cells (10^5 to 10^7) concentrate (3-5 ml solution) harvested from the iliac crest and injected at the injury site.
|
| Comparator Agent |
MRI compatible medical grade titanium alloy (Ti-6AL-4V ELI) pedicle screws and rods system |
Surgical fixation using MRI compatible medical grade titanium alloy (Ti-6AL-4V ELI) pedicle screws and rods system by standard procedure to stabilize the spinal column. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Acute spinal cord injury within 1 week having ASIA score A morbidity |
|
| ExclusionCriteria |
| Details |
Previous spinal surgeries, associated multisystem injuries, inability to comply with follow-up, no associated comorbidities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the American Spinal Injury Association (ASIA) score, Functional independence measure (FIM) scores |
3, 6, 12 months and then yearly for 2 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life assessed by the EQ-5D scale, SCIM spinal cord independence measure, functional (10MWT, 6MWT, TUG, WISCI2) |
1 month, 3 months, 6 months, 12 months, 2 years |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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 1 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to evaluate the safety and efficacy of a biological scaffold in patients with acute spinal cord injury. It is a randomized comparative study involving surgical fixation with or without scaffold treatment. The scaffold is combined with exosomes and autologous bone marrow concentrate to support neural recovery. Participants will be monitored for neurological improvement and quality of life over a 2-year period using standard scoring systems. The research is a multi-institutional collaboration between IMS BHU and IIT Kanpur. |