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CTRI Number  CTRI/2026/01/101280 [Registered on: 15/01/2026] Trial Registered Prospectively
Last Modified On: 13/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Laboratory based invitro experimental study 
Study Design  Other 
Public Title of Study   Studying Factors contributing to muscle loss or strength 
Scientific Title of Study   Developing an invitro system of human skeletal muscle to validate biomarkers of sarcopenia. 
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 Niranjan 
Designation  Consultant Orthopedics 
Affiliation  Bangalore Baptist Hospital 
Address  Room No 129, Ground floor, Main building, Orthopedics department, Bangalore Baptist Hospital, Hebbal, Bangalore
Room No 129, Ground floor, Main building, Orthopedics department, Bangalore Baptist Hospital, Hebbal, Bangalore
Bangalore
KARNATAKA
560024
India 
Phone  9449001918  
Fax    
Email  onsnir@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Niranjan 
Designation  Consultant Orthopedics 
Affiliation  Bangalore Baptist Hospital 
Address  Room No 129, Ground floor, Main building, Orthopedics department, Bangalore Baptist Hospital, Hebbal, Bangalore
Room No 129, Ground floor, Main building, Orthopedics department, Bangalore Baptist Hospital, Hebbal, Bangalore

KARNATAKA
560024
India 
Phone  9449001918  
Fax    
Email  onsnir@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Niranjan 
Designation  Consultant Orthopedics 
Affiliation  Bangalore Baptist Hospital 
Address  Room No 129, Ground floor, Main building, Orthopedics department, Bangalore Baptist Hospital, Hebbal, Bangalore
Room No 129, Ground floor, Main building, Orthopedics department, Bangalore Baptist Hospital, Hebbal, Bangalore

KARNATAKA
560024
India 
Phone  9449001918  
Fax    
Email  onsnir@yahoo.co.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  inStem 
Address  inStem, GKVK - Post, Bellary Road, Bangalore 560065, India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Niranjan  Bangalore Baptist Hospital  Room No 129, Ground floor, Main building, Orthopedics department, Bangalore Baptist Hospital, Hebbal, Bangalore Room No 129, Ground floor, Main building, Orthopedics department, Bangalore Baptist Hospital, Hebbal, Bangalore
Bangalore
KARNATAKA 
09449001918

onsnir@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Bangalore Baptist Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M233||Other meniscus derangements,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Apparently healthy young adults (20-40 years) undergoing arthroscopic knee surgeries
2. People above 60 undergoing arthroscopic knee surgeries/total knee replacement surgeries 
 
ExclusionCriteria 
Details  1. End organ failure
2. Malignancy
3. Psychiatric disorders/poor mental health 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To develop an an invitro system of human myoblast (Isolation and culture of human primary
muscle progenitor cells (hMPCs)) 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To validate the invitro system of human myoblast by comparing biomarkers and signatures of
sarcopenic and non sarcopenic muscle fibres 
6 months 
To test the effect of metabolic factors (including a few amino acids and a dietary flavanone)
on skeletal muscle myogenesis and metabolism as surrogate measurements for sarcopenia in
the invitro system developed. of human myoblast 
6 months 
 
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   N/A 
Date of First Enrollment (India)   27/01/2026 
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="0"
Months="6"
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 titled “Developing an in vitro system of human skeletal muscle to validate biomarkers of sarcopenia” is a collaborative project between Bangalore Baptist Hospital (BBH), inStem, and Vyah Vikas. The research aims to develop a laboratory-based (in vitro) human skeletal muscle model to study and validate metabolic biomarkers and compounds associated with sarcopenia, the age-related loss of muscle mass and strength. In an earlier study involving 40 older participants, 295 lipids and 308 metabolites were analyzed using advanced metabolomic and lipidomic techniques. Through machine learning (Support Vector Machine algorithm), a panel of ten metabolites predictive of sarcopenia was identified, achieving an accuracy of 88.89%. Animal experiments conducted at inStem confirmed the protective effects of compounds such as homoarginine and karanjin, suggesting their potential role in promoting muscle maintenance and function.The present study aims to translate these findings to human cells by isolating and culturing human primary muscle progenitor cells (hMPCs) from subjects undergoing knee surgeries. A total of 12 participants will be recruited, six young adults (20–40 years) and six older adults (greater than 60 years). Small biopsies (10 × 15 mm) of the vastus medialis muscle will be collected during surgery without any additional incision or discomfort. The samples will be transported to inStem, where cells will be isolated, characterized, and treated with selected metabolic factors, including amino acids and a dietary flavanone.These treatments will be evaluated for their ability to improve myogenesis (muscle formation) and metabolic activity, serving as surrogate markers for sarcopenia. Participation is voluntary, informed consent will be obtained, and all ethical standards will be strictly followed. The study is expected to provide a novel human-based platform for understanding muscle aging and pave the way for developing potential therapeutic strategies against sarcopenia.


 
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