CTRI/2025/03/082846 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On:
27/03/2026
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
This is an observational study to evaluate the safety and effectiveness of marketed product StemOne™ injection in patients with Osteoarthritis of Knee.
Active Post Marketing Surveillance Study to Evaluate the Safety and Effectiveness of StemOneTM in patients with Osteoarthritis (OA) of Knee.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
SRPL/OA/22-23/001 Version 4.0 dated 12 Apr 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
DrPawan Kumar Gupta
Designation
President- Medical & Regulatory Affairs
Affiliation
Stempeutics Research Pvt Ltd
Address
3rd Floor,
Manipal Hospitals Whitefield Pvt. Ltd.
143, 212-215, EPIP Industrial Area
ITPL Main Road, Bengaluru -560048, Karnataka, India
NA Bangalore KARNATAKA 560048 India
Pauja, Patrapada, Bhubaneshwar, Odisha-751019, India Khordha ORISSA
9438884155
sujitortho@yahoo.co.in
Dr Abheek Kar
Apollo Multispecialty Hospitals, Limited
Apollo Multispecialty Hospitals, Limited.
58 Canal Circular Road, Kolkata
West Bengal -7000054, India
Kolkata WEST BENGAL
9836722586
abheekkar@gmail.com
Dr Ravi Sauhta
Artemis Hospital
Department –Director and Hod of Orthopedics and Joint Replacement,
Orthopedics (Unit VI)
Address - Artemis Hospital, Sector-51, Gurugram, Haryana-122001
Gurgaon HARYANA
9811411271
ravi.sauhta@artemishospitals.com
DrNikhil Gupta
Centre for Arthritis and Rheumatological Diseases
Ground Floor,
E-1083, Saraswati Vihar, opposite Saral diagnostics,
Pitampura, New Delhi-110034
New Delhi DELHI
9873098719
drnikhilguptamamc@gmail.com
Dr Amit Kumar Agarwal
Indraprastha Apollo Hospitals, New Delhi
Room No. – Gate No.2
Floor No. – 02
Department –Department of Orthopedics.
Address - Indraprastha Apollo Hospitals, Sarita Vihar, Mathura Road, New Delhi-110076
New Delhi DELHI
9968578514
amitorthopgi@yahoo.co.in
Dr Lokesh AV
Manipal Hospital, Bangalore
Room No.35, Upper Basement,
Department of Orthopedic & Robotic Joint Replacement Surgery,
Manipal Hospitals, #98, Old Airport Road,
Bengaluru (Bangalore), Urban Karnataka- 560017- India
Bangalore KARNATAKA
9845740443
drlokeshav@gmail.com
Dr Ravi Velamur Rangarajan
Maruti Hospital, Trichy
Department of Orthopedics & Regenerative Medicine, Maruti Hospital, 95 Pattabiraman Street, Tennur, Trichy - 620017
Madurai TAMIL NADU
9842426141
drvrraviortho@gmail.com
Dr Kiran Kumar Mukhopadhyay
Nil Ratan Sircar Medical College & Hospital
Professor, Department of Orthopedics
138, AJC Bose Road, Kolkata-700014, West Bengal, India
Kolkata WEST BENGAL
94331 66270
orthokiran@gmail.com
Dr Vijay Goni
Post Graduate Institute of Medical Education and Research
Department of Orthopedics, Ground Floor, B Block, Nehru Hospital
Sector-12, Chandigarh-160012, India. Chandigarh CHANDIGARH
9815712727
vijaygoni@gmail.com
Dr Dave Dhrumil
Shardaben Chimanlal Lalbhai Municipal General Hospital
Room No-A15, First floor, Department of Orthopedics, Saraspur, Ahmedabad, Gujarat-380018, India Ahmadabad GUJARAT
9662215616
dhrumil1990@gmail.com
Dr SS Amarnath
TrinityTrinity Hospital and Heart Foundation
Room No. – 07
Floor No. – Ground Floor
Department- Department of Orthopedics,
Address - Teachers college Circle, Rashtriya Vidyalaya Road, Near Lalbagh Metro Station
Basavanagudi, Bengaluru, Karnataka- 560004, India
Bangalore KARNATAKA
9886046638
bonenjointsurgeon@yahoo.co.in
Dr Anant Eknath Bagul
Universal Hospitals, Pune
Room No. – OPD 01
Floor No. – Ground Floor
Department –Orthopedics
Address - Universal Hospital, 1420, Kasha Peth, Near Shaniwar Wada, Pune, Maharashtra-411011
India
Pune MAHARASHTRA
ACE Independent Ethics Committee Quinary Clinical Research Pvt Ltd
Approved
Artemis Health Sciences Institutional Ethics Committee
Approved
Central Independent Ethics Committee-Gini Aria, A-703, S.No. 16/2/2A/1/ opposite to KJEIs Trinity College, Kondhwa Annex, Pune, Maharashtra-411048, India
Approved
Ethics Committee of Manipal Hospitals No 98, Old Airport Road No 98, Old Airport Road Bangalore Bengaluru (Bangalore) Urban Karnataka - 560017 India
Approved
Ethics Committee Plasmaart Resto Private Limited, 44A, 1st Floor Vishranthi Suriya Complex, MGR Nagar, Puthur, Trichirapalli, Tamil Nadu- 620017
Approved
Ethics Committee, N.R.S Medical College Nil Ratan Sircar Medical College & Hospital, 138, AJC Bose Road, Kolkata-700014, West Bengal, India
Approved
Good Society for Ethical Research, H.No. -D/129, ST.No.13, Opp. Durga Mandir, Ashok Nagar, Shahdara, North-East, Delhi-110093
Approved
Institutional Ethics Committee -Post Graduate Institute of Medical Education and Research Room No. 6006, IEC Office, 6th Floor P N Chuttani Block Chandigarh -160012 India
Approved
Institutional Ethics Committee, Apollo Multispeciality Hospitals Limited, 58 Canal Circular Road, Kadapara Kolkata West Bengal -7000054, India
Approved
Institutional ethics committee, faculty Research, All India Institute of Medical Sciences, BBSR, AIIMS Bhubaneswar Sijua P/O Patrapada Bhubaneswar Khordha Orissa - 751019 India
Approved
Institutional Ethics Committee, NHLIEC, Smt. NHL Municipal Medical College, V S Hospital Campus, Ellisbridge, Ahmedabad, Gujarat – 380006, India
Approved
Institutional Ethics Committee-Clinical Study (IEC-CS) - Indraprastha Apollo Hospital, Mathura Road, new Delhi-110076
intra-articular injection of (25 million cells in 1ml of CryoStor® CS5 + 1ml PlasmaLyte-A), followed by 2 ml Hyalgan (Sodium Hyaluronate injection).
Pretreatment : Appropriate dosage of IV steroid (eg: 100 mg of hydrocortisone) and antihistaminic (eg: 45.5 mg pheniramine maleate)
1Written, signed, dated informed consent obtained from patients
2Patients of either sex of 40 years and above with Grade 2 & Grade 3 Osteoarthritis of knee based on the Kellgren and Lawrence radiographic criteria
Patients with BMI <30kgm2
ExclusionCriteria
Details
Patients with known hypersensitivity to hyaluronan products or animal sera or constituents of StemOneTM
Safety evaluation assessments:
1.Evaluation of Adverse events
2.Evaluation of drug related adverse events
3.Occurrence of clinical abnormality at the site of injection, vital signs and physical examinations and laboratory investigations
4.VAS Score
5.Assessment of Biomarkers – CTX II (Urine) and IL-10 (Serum)
6.MRI of Knee joint (T2 mapping), cartilage volume & cartilage thickness (to be done in consenting patients only)
At 1, 3, 6,12,18, 24, 30 & 36 months
MRI at Visit 1 (Baseline) & Visit 10 (24 Months)
Secondary Outcome
Outcome
TimePoints
NA
NA
Target Sample Size
Total Sample Size="200" Sample Size from India="200" 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
Post Marketing Surveillance
Date of First Enrollment (India)
31/03/2025
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="4" 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
Osteoarthritis (OA) is a chronic degenerative disorder of multifactorial etiology characterized by the loss of articular cartilage, hypertrophy of bone at the margins, subchondral sclerosis and range of biochemical and morphological alterations of the synovial membrane and joint capsule.
It typically involves an entire joint, with the most affected joints being the hips, knees, hands and spine. Common manifestations of osteoarthritis are stiffness and pain. There are a variety of risk factors for osteoarthritis, including high-impact sports, obesity and bone deformities. The prevalence of osteoarthritis increases with obesity and age.
Knee OA is the most leading cause of disability and pain in the adult and old age population. An estimated 10 to 15% of all adults aged over 60 have some degree of OA, with prevalence higher among women than men. Knee OA impairs the physical functions and worsens the quality of life.
Most cases of OA have no known cause and are referred to as primary OA. Primary osteoarthritis is mostly related to aging. It can present as localized, generalized, or as erosive OA. Secondary osteoarthritis is caused by another disease or condition.
This
study will include 200 patients administered with StemOneTM in
multiple centres across India. The patients will receive an intra-articular
injection of StemOneTM (25 million cells in 1ml of CryoStor®
CS5 + 1ml PlasmaLyte-A), followed by 2 ml Hyalgan (Sodium Hyaluronate
injection). These patients will be followed up for duration of 36 months from
the time of administration of StemOneTM.