| 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
|
|
|
Primary Sponsor
|
| Name |
inStem |
| Address |
inStem, GKVK - Post, Bellary Road, Bangalore 560065, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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. |