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CTRI Number  CTRI/2018/09/015785 [Registered on: 20/09/2018] Trial Registered Prospectively
Last Modified On: 17/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Stem Cell Therapy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to evaluate the effects of stem cells in patients with Osteoarthritis of the Knee joint  
Scientific Title of Study   A Randomized, Double blind, Multicentric, Placebo controlled, Phase III study assessing the efficacy and safety of Intra-articular administration of Stempeucel®(Adult Human Bone Marrow derived, cultured, pooled, allogenic Mesenchymal stromal cells)in patients with Osteoarthritis of Knee 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SRPL/OA/16-17/001; Version No 3.0 dated 05 Jul 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pawan Gupta 
Designation  Vice President- Medical Affairs 
Affiliation  Stempeutics Research Pvt Ltd 
Address  Stempeutics Research Pvt Ltd 3rd Floor, Manipal Hospitals Whitefield Pvt Ltd. # 143, 212-215, EPIP Industrial Area, ITPL Main Road,

Bangalore
KARNATAKA
560048
India 
Phone  91-80-25028101  
Fax    
Email  pawan.gupta@stempeutics.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pawan Gupta 
Designation  Vice President- Medical Affairs 
Affiliation  Stempeutics Research Pvt Ltd 
Address  Stempeutics Research Pvt Ltd 3rd Floor, Manipal Hospitals Whitefield Pvt Ltd. # 143, 212-215, EPIP Industrial Area, ITPL Main Road,

Bangalore
KARNATAKA
560048
India 
Phone  91-80-25028101  
Fax    
Email  pawan.gupta@stempeutics.com  
 
Details of Contact Person
Public Query
 
Name  Jijy Abraham 
Designation  Senior Executive-Regulatory & Clinical Trials 
Affiliation  Stempeutics Research Pvt Ltd 
Address  Stempeutics Research Pvt Ltd 3rd Floor, Manipal Hospitals Whitefield Pvt Ltd. # 143, 212-215, EPIP Industrial Area, ITPL Main Road,

Bangalore
KARNATAKA
560048
India 
Phone  91-80-25028112  
Fax    
Email  jijy.abraham@stempeutics.com  
 
Source of Monetary or Material Support  
Stempeutics Research Pvt Ltd 3rd floor Manipal Hospitals Whitefield, #143, 212-215, EPIP Industrial Area, ITPL Main Road, Bangalore - 560048 
 
Primary Sponsor  
Name  Stempeutics Research Pvt Ltd 
Address  3rd Floor, Manipal Hospitals Whitefield, #143, 212-215, EPIP Industrial Area, ITPL Main Road, Bengaluru - 560048 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 16  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sujit Kumar Tripathy  All India institute of Medical Sciences,Bhubhaneshwar  OPD, Ground floor, All India institute of Medical Sciences, Village Sijua, Patrapada, PO Dum Duma, Bhubhaneshwar 751019, Odisha India
Cuttack
ORISSA 
91-9438884155

ortho_sujit@aiimsbhubaneswar.edu.in 
Dr Syamasis Bandyopadhyay  Apollo Gleneagles Hospitals  Apollo Gleneagles Hospitals 58-Canal circular road, Kolkata- 700054
Kolkata
WEST BENGAL 
9836576602

sambando@yahoo.co.uk 
Dr Saurabh Singh  Banaras Hindu University   Department of Orthopaedics, IMS, BHU, Varanasi- 221005
Varanasi
UTTAR PRADESH 
9838759998

saurabhrpsingh@gmail.com 
Dr Vivek Pandey  Kasturba Medical College,Manipal  Room No. 03, Department of Orthopaedics, Kasturba Medical College, Manipal, Karnataka, 576104, India
Udupi
KARNATAKA 
91-820-2922677
91-820-2922928
vivekortho@gmail.com 
Dr M Pardha Saradhi  King George Hospital, Visakhapatnam  Room No. 10, Department of Orthopaedics ,King George Hospital, Visakhapatnam- 53002, AP
Visakhapatnam
ANDHRA PRADESH 
91-9440608752

amcorthopaedics@hotmail.com 
Dr Surendra Umesh Kamath  KMC Hospital, Mangalore   Department of Orthopaedics, KMC Hospital, Attavar Mangalore- 575001
Dakshina Kannada
KARNATAKA 
9844275231

skamath3@hotmail.com 
Dr Vishal Patil  Lifepoint MultispecialityHospital Pvt. Ltd  Room No. 104, 1st Floor, Lifepoint Multispeciality Hospital Pvt. Ltd., 145/1, Mumbai - Bangalore Highway, Near Hotel Sayaji, Wakad, Pune - 411057, Maharashtra, India
Pune
MAHARASHTRA 
9405431728

pvlife200@gmail.com 
Dr Naresh Shetty  M. S. Ramaiah Memorial Hospital  Room No. 09, Department of Orthopaedics, M. S. Ramaiah Medical College, MSR Nagar, MSRIT Post, Bangalore 560054, Karnataka, India
Bangalore
KARNATAKA 
91-80-22183274
91-80-40528402
nareshs8@hotmail.com 
Dr Sunil Maheshwari  Medilink Hospital, Ahmedabad  Medilink Hospital Research Centre, Basement Medilink Hospital, Nr. Shyamal Cross Road, 132 ft Ring road, Satellite, Ahmedabad, 380015,
Ahmadabad
GUJARAT 
9898983555

maheshwarisunil@live.com 
Dr Vijay Goni  Postgraduate Institute of Medical Education and Research,Chandigarh  "C- Block, Room no 003, Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences Raebareli Road, Lucknow - 226 014 "
Chandigarh
CHANDIGARH 
91-7087009747

vijaygoni@gmail.com 
Dr Parag Kantilal Sancheti  Sancheti Institute for Orthopaedics & Rehabilitation  Room No. 03, Department of Orthopaedics, Sancheti Institute for Orthopaedics & Rehabilitation, Clinical Research Division, 1st Floor, Sancheti Research Department, 16 Shivaji Nagar, Pune 411005, Maharashtra, India
Pune
MAHARASHTRA 
91-9823553333
91-9822353333
parag@sanchetihospital.org 
Dr Vikas Agarwal   Sanjay Gandhi Post Graduate Institute of Medical Sciences  "C- Block, Room no 003, Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences Raebareli Road, Lucknow - 226 014
Lucknow
UTTAR PRADESH 
91-522-2494318
91-522-2668812
vikasagr@yahoo.com 
Dr Purohit Sharad Prahaladbhai  Sanjivani Super specialty Hospital Pvt Ltd.Ahmadabad  Uday park society, Nr. Sunrise park, Vastrapur, Ahmedabad- 380015
Ahmadabad
GUJARAT 
9879007908

dr_sharadpurohit@hotmail.com 
Dr Arun Kumar Sharma  SMS HOSPITAL & MEDICAL COLLEGE  77, 5th floor Dhanwantri OPD Block, SMS, J.L.N. Marg, Jaipur, Rajasthan 302004
Jaipur
RAJASTHAN 
91-7891688519

drarunsharmasms@gmail.com 
Dr Joe Joseph Cherian  St. John s Medical College, Bangalore   Department of Orthopedic, St. John s Medical College, Koramangala, Bangalore- 560034
Bangalore
KARNATAKA 
9343794300

cherianjoe71@gmail.com 
Dr Keerthi Talari  Yashoda hospital  Room No. 37, 1st floor, Yashoda hospital, Behinf Hari Hare Kala, Bhaware , Secundrabad - 500003, T.S.
Hyderabad
TELANGANA 
91-951558292

keerthitalari298@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 16  
Name of Committee  Approval Status 
Banaras Hindu University,Varanasi  Approved 
Ethical Review Board, M. S. Ramaiah Memorial Hospital   Approved 
Ethics committee of SMS Medical College and Attached Hospitals Office of Ethics Committee First Floor, Allergy Clinic, Dhanwantri, OPD Block SMS Hospital, JLN Marg, Jaipur – 302004  Approved 
Ethics Committee,Medilink Hospital  Approved 
Institutional Ethics Committee, Apollo Gleneagles Hospitals, 58-Canal circular road, Kolkata, 700054, West Bengal   Approved 
Institutional Ethics Committee, PGIMER Room no. 6006, IEC office, A, 6th floor, PN Chuttani Block, PGIMER Chandigarh 160012, India  Approved 
Institutional Ethics Committee, St.Johns Medical college & Hospital   Approved 
Institutional Ethics Committee“, All India Institute of Medical Sciences Bhubaneswar, AIIMS Road, Sijua, Patrapada, Bhubaneswar, Odisha 751019, India  Approved 
Institutional Ethics Committee“, King George Hospital, Maharanipeta, Visakhapatnam- 530002, Andhra Pradesh, India  Approved 
LPR ethics Ethics Committee, Lifepoint Multispecialtiy Hospital Pvt ltd situated at 145/1 Mumbai Banglore Higway Near Hotel Sayaji Wakad Pune 411057 Maharashtra India  Approved 
MAHE Ethics Committee   Approved 
Manipal University Ethics Committee   Approved 
Sancheti Institutional Review Board   Approved 
Sanjivani Hospital Ethics Committee  Approved 
SGPGI Ethics Committee, Lucknow  Approved 
Yashoda Academy of Medical Education and Research (YAMER-IEC)“, Yashoda hospital, Behind Hari Hara Kala bhawan, Secunderabad - 500003, Telangana, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Osteoarthritis of the Knee joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  2 ml ( 1 ml Cryostor CS5 +1 ml PlasmaLyte A) single dose intraarticular followed by 2 ml hyaluronan. It is a one time injection at baseline. 
Intervention  Stempeucel®   stempeucel®- Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells suspended in 1 ml CryoStor CS5® + 1 ml PlasmaLyte A. It is a one time injection at baseline. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Males or females in the age 40 – 65 years (both inclusive)
2. History of primary osteoarthritis of the knee characterized by pain which requires intake of analgesics
3. Self-reported difficulty in at least one of the following activities attributed to knee pain: lifting and carrying groceries, walking 400 meters, getting in and out of a chair, getting up from squatting or cross leg position or going up and down stairs
4. Patient on analgesic medication for OA, for 6 weeks based on Investigator’s feedback.
5. Radiological criteria
X-ray knee joint showing radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic criteria (based on site radiologist report).
6. Willing to refrain from any other stem cell treatment for 2 year during the study.
7. Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
8. Willing to provide written informed consent including audio-video consent
 
 
ExclusionCriteria 
Details  1. X-ray (evaluated by central radiologist) showing any of the following:
a. Grade 0, 1 and 4 osteoarthritis based on the Kellgren and Lawrence radiographic criteria
b. Subchondral sclerosis
2. MRI knee (evaluated by central radiologist) showing any of the following:
a. ACL/ PCL tears
b. Meniscal tears: Grade 3 tears - defined as increased signal intensity on PD sequences extending up to either articular surface. It also includes root tear but excludes RAMP tear
c. Patients with exclusive patello-femoral arthritis
d. Grade 0, 1 and 4 arthritis as per the proposed grading on MRI
3. Prior or ongoing medical conditions (e.g., concomitant illness, psychiatric condition), alcoholism, smoking, tobacco chewing or drug abuse, medical history, physical findings, ECG findings or laboratory abnormality that, in the investigator‘s opinion could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results
4. History of surgery or major trauma to the study joint
5. Arthroscopy on the study joint in the previous 12 months
6. Signs of active study joint inflammation including redness, warmth, and/or, if qualifying with osteoarthritis of the knee, a large, bulging effusion of the study knee joint with the loss of normal contour of the joint at the screening visit or at the baseline examination
7. Acute exacerbations of the study joint in the past 6 weeks
8. Patients who had received intra-articular steroids or hyaluronan within the last 3 months
9. Patients who had taken any stem cell treatment in the past by any route of administration
10. Infections in or around the study knee
11. Patients awaiting a replacement of knee or hip joint
12. Patients with other conditions that cause pain in the knee joint
13. Patients with gross deformity (varus by x-ray of the knee or flexion deformity > 10° by gonometer) of the knee joint based on PI judgment
14. Significantly incapacitated or disabled and would be categorized as ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without assistive devices
15. Patients with any secondary causes of arthritis e.g. rheumatoid arthritis, systemic lupus erythematous, ulcerative colitis, psoriasis, rheumatic or inflammatory disease
16. Patients with BMI ≥30 kg/m2
17. Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human immunodeficiency virus – I & II (HIV – I & II) antibody test, TPHA or CMV (IgM)
18. History of Bleeding disorders
19. Known hypersensitivity to hyaluronan products or animal sera or constituents of IMP
20. Pregnancy, breast-feeding, planned pregnancy during the study, or women of child-bearing potential not using adequate contraception
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the change from baseline to one year in WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Osteoarthritis Composite Index score as compared to the placebo arm  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the change from baseline to two year in WOMAC
To assess the change from baseline to one year and two years follow-up as compared to the placebo arm in
1. WOMAC OA Pain Index
2. WOMAC OA Stiffness Index
3. WOMAC OA Physical Function Index
Patients Assessment of Osteoarthritis Pain by VAS
Assess the quality of articular cartilage by T2 mapping
Cartilage thickness-MRI
Cartilage volume-MRI
Reduction in intake of analgesics 
2 years 
 
Target Sample Size   Total Sample Size="146"
Sample Size from India="146" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   24/09/2018 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Non yet 
Brief Summary   This study is randomized, double blind, multi-centric, placebo controlled, single dose phase 3 study to evaluate the efficacy and safety of bone marrow derived allogeneic mesenchymal stromal cells in patients with osteoarthritis of knee joint 
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