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CTRI Number  CTRI/2025/11/097065 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On: 05/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Stem Cell Therapy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Stem Cell Application in Nerve Transfer Surgery for Traumatic Brachial Plexus Injury: A Pilot Trial on Safety and Functional Outcomes 
Scientific Title of Study   Feasibility Safety and Early Functional Outcomes of Intra operative Bone Marrow Derived Stem Cell (BMSC) Application Versus Conventional Repair Alone in Nerve Transfer Surgery for Traumatic Brachial Plexus Injury A Randomised Double Blind Pilot Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivam Sharma 
Designation  Senior Resident 
Affiliation  All India Institute Of Medical Sciences 
Address  room no. 543 Department of Burns Plastic and Reconstructive Surgery All India Institute Of Medical Sciences Patna
room no. 543 Department of Burns Plastic and Reconstructive Surgery All India Institute Of Medical Sciences Patna
Patna
BIHAR
801507
India 
Phone  9971148400  
Fax    
Email  drshivamsharma1509@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Veena Kumari Singh 
Designation  Additional Professor & head 
Affiliation  All India Institute Of Medical Sciences 
Address  room number 542 Department of Burns Plastic and Reconstructive Surgery All India Institute Of Medical Sciences Patna
Department of Burns Plastic and Reconstructive Surgery All India Institute Of Medical Sciences Patna
Patna
BIHAR
801507
India 
Phone  9905755111  
Fax    
Email  drsveena@aiimspatna.org  
 
Details of Contact Person
Public Query  
Name  Shivam Sharma 
Designation  Senior Resident 
Affiliation  All India Institute Of Medical Sciences 
Address  702, ojas building, hari nagar group housing, hari nagar
Department of Burns Plastic and Reconstructive Surgery All India Institute Of Medical Sciences Patna
Patna
BIHAR
801505
India 
Phone  9971148400  
Fax    
Email  drshivamsharma1509@gmail.com  
 
Source of Monetary or Material Support  
All India institute of medical sciences Patna Bihar 801507 
 
Primary Sponsor  
Name  Department of burns plastic and reconstructive surgery 
Address  Department of burns plastic and reconstructive surgery All India Institute Of Medical Sciences Patna Bihar 801507 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Department of Biochemistry  Department of Biochemistry All India Institute Of Medical Sciences Patna Bihar 801507 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivam Sharma  All India Institute of Medical Sciences, Patna  Department of Burns Plastic and Reconstructive Surgery All India institute Of Medical Sciences Patna 801507
Patna
BIHAR 		 9971148400

drshivamsharma1509@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G540||Brachial plexus disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  distal nerve injection  1ml of cell suspension will be injected into the distal nerve using 27G needle intraoperatively single sitting at time of surgery. total duration : single intra op application. 
Intervention  repair site administration  1 ml of cell suspension of the prepared BMSC susppension will be administered circumferentially at nerve reapair site using 30G needle intraoperatively single sitting at time of surgery. duration : single intra op application. 
Comparator Agent  saline injection   1 ml of saline will be injected all around at repair site intraoperatively single sitting at time of surgery. total duration : single intra op application. 
Comparator Agent  saline injection  1 ml of saline will be injected into the distal nerve using a 27G needle intraoperatively single sitting at time of surgery. total duration :single intra op application 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  patients diagnosed with Pan or extended traumatic upper upper trunk brachial plexus injury of less than 7 months requiring surgical repair namely
oberlins repair
Spinal accessory to Supra spinatous nerve transfer repair via anterior of posterior approach
Intercostal nerve to median nerve transfer
intercostal nerve to musculocutaneous nerve transfer

patients consenting to intra operative bone marrow derived stem cell application at the nerve reapir site and distal nerve
No history of malignancies or active infection
ability to provide written informed consent and comply with follow up assessments
 
 
ExclusionCriteria 
Details  patients with a history of autoimmune disease or significant immunosuppression
presence of systemic conditions affecting nerve reapair outcomes like uncontrolled diabetes and severe vascular disease
pregnant of lactating women
previous brachial plexus repair surgeries or alternative regenrative therapies for the same injury 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
recruitment rate
consent rate
retention rate
BMSC processing time
protocol adherence
adverse events
bone marrow site pain 		 arrival,admission, Post op day 0,3, 1 month, 3 month, 6 month and 9 month 
 
Secondary Outcome  
Outcome  TimePoints 
muscle strength MRC grading
goniometric measurements of shoulder abduction and elbow flexion in degree
10 cm VAS
NCS
MRI 		 at recruitment, 1 month, 3 month, 6 month, 9 month
at recruitment,1 month, 3 month, 6 month, 9 month
at recruitment, 3 month, 6 month, 9 month
3 month, 6 month, 9 month
6 month, 9 month
6 month, 9 month 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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   N/A 
Date of First Enrollment (India)   20/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/11/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 single center randomized double blind pilot at AIIMS Patna Department of Burns Plastic and Reconstructive Surgery will evaluate feasibility safety and early recovery when autologous bone marrow derived stem cells are injected at the nerve repair site and into the distal nerve during standard nerve transfer procedures for traumatic brachial plexus injury Eligible adults aged eighteen to sixty five within seven months of injury will be randomized one to one to surgery plus stem cells or surgery with sham injection Follow up visits occur at one three six and nine months Primary outcomes include recruitment consent retention adherence stem cell processing time and adverse events Secondary outcomes assess early function using MRC muscle grades shoulder and elbow range of motion DASH questionnaire nerve conduction and MRI 
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