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CTRI Number  CTRI/2015/04/005661 [Registered on: 01/04/2015] Trial Registered Prospectively
Last Modified On: 23/08/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Autologous Adult Live Cultured Chondrocytes (CHONDRON®)]  
Study Design  Single Arm Study 
Public Title of Study   Clinical Study to Assess the Safety and Efficacy of Autologous Adult Live Cultured Chondrocytes (CHONDRON®) in Subjects with Articular Cartilage Defects of the Articulating Joint(s).  
Scientific Title of Study   A Prospective, Open-label, Multicentric Study to Assess the Safety and Efficacy of Autologous Adult Live Cultured Chondrocytes (CHONDRON®) in Subjects with Articular Cartilage Defects of the Articulating Joint(s). 
Trial Acronym  NA 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
RMS/CH/ACD/1201 version 1.3 dated 11 Feb 2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Ashoka Kumar Singh 
Designation  Head of Department- Clinical Operations  
Affiliation  Veeda Clinical Research Pvt. Ltd. 
Address  Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM, Ambawadi, Ahmedabad-380015, Gujarat India Ahmadabad GUJARAT 380015 India

Ahmadabad
GUJARAT
380015
India 
Phone  079-30013000  
Fax  079-30013010  
Email  Ashoka.Singh@veedacr.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Ashoka Kumar Singh 
Designation  Head of Department- Clinical Operations  
Affiliation  Veeda Clinical Research Pvt. Ltd. 
Address  Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM, Ambawadi, Ahmedabad-380015, Gujarat India Ahmadabad GUJARAT 380015 India

Ahmadabad
GUJARAT
380015
India 
Phone  079-30013000  
Fax  079-30013010  
Email  Ashoka.Singh@veedacr.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Dr Ashoka Kumar Singh 
Designation  Head of Department- Clinical Operations  
Affiliation  Veeda Clinical Research Pvt. Ltd. 
Address  Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM, Ambawadi, Ahmedabad-380015, Gujarat India Ahmadabad GUJARAT 380015 India

Ahmadabad
GUJARAT
380015
India 
Phone  079-30013000  
Fax  079-30013010  
Email  Ashoka.Singh@veedacr.com  
 
Source of Monetary or Material Support  
Regenerative Medical Services Pvt Ltd  
 
Primary Sponsor  
Name  Regenerative Medical Services Pvt Ltd  
Address  2-ABC, ACME Plaza, Above Indusind Bank, Andheri Kurla Road, Andheri(E), Mumbai -400059  
Type of Sponsor  Other [[Company for Advanced Cell Therapy Treatments]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Raghuveer Reddy  Centre for Advanced Orthopedic surgery, Krishna Institute of Medical Sciences (KIMS),   Centre for Advanced Orthopedic surgery, Krishna Institute of Medical Sciences (KIMS), 1-8-31/1, Minister Road, Secunderabad – 500 003, AP, India.
Hyderabad
ANDHRA PRADESH 
9849029934

raghuveer3@rediffmail.com 
Dr Shirish Phatak  DeenanthMangeshkar Hospital & Research Centre  Deenanth Mangeshkar Hospital & Research Centre,Near Mhatre Bridge Erandwane, Pune-411 004, INDIA.
Pune
MAHARASHTRA 
9822522362

drshirishp@gmail.com 
Dr Kiran Acharya  Kasturba Medical College & Hospital  Kasturba Medical College & Hospital,SH 65, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA 
9343130539

manipalortho@gmail.com 
Dr Deepak Chaudhary  Vardhman Mahavir Medical College & Safdarjung Hospital   Sports Injury Centre, Unit I- Arthroscopy & Sports injury, Vardhman Mahavir Medical College &Safdarjung Hospital Opposite AIMS Hospital,Ansari Nagar West, Safdarjung, New Delhi,110029
New Delhi
DELHI 
9810430634

deepakchaudhary@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics CommitteeDeenanath Mangeshkar Hospal & Research Centre  Approved 
KFRC Ethics Committee  Approved 
Manipal University Ethics Committee  Approved 
V.M. Medical college & Safdarjang Hospital Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Articular Cartilage Defects of the Articulating Joint(s).,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CHONDRON (Autologous Adult Live Cultured Chondrocytes)  Colourless transparent vial product, which contains mixed precipitated pale-white-coloured autologous adult live cultured chondrocytes and red coloured fluid. This fluid becomes turbid when shaken. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male or female subjects aged 18 to 65 years (both inclusive) with focal, ICRS (grade III or IV) articular cartilage defects on the weight bearing surface of the articulating joint(s).
2.Subjects with articular cartilage defects of the articulating joint diagnosed by visual examination, digital X-Ray and MRI (size of the defect more than 1 cm2 or less than 15 cm2).
3.Subjects with intact meniscus, stable knee, with normal alignment (corrective procedure may be performed in combination with or prior to biopsy) with a normal joint space with no inflammation or arthritic changes in the joint.
4.Subjects reported with bilateral defects shall be included, however only unilateral defect will be treated at a time and not together.
5.Subject is willing and able to comply with post-operative weight-bearing restrictions and rehabilitation.
6.Body mass index (BMI) <35 kg/m2.
7.Subjects (or legally acceptable representative [LAR] of impartial witness) who are able to provide written informed consent prior to participation in the study. 
 
ExclusionCriteria 
Details  1.Subjects with degenerative changes like osteoarthritis and recommended for total knee replacement avascular necrosis and articular cartilage defects with kissing lesions.
2.Subjects with tibio-femoral mal-alignment of articulating joints, instability of articulating joint ligament, and/or bone defects around area of defective cartilage.
3.Subjects with inflammatory arthritis, such as osteoarthritis and gouty arthritis.
4.Subjects with autoimmune disease related rheumatoid arthritis.
5.Subjects who are pregnant, breast-feeding or have childbearing potential and have had a positive pregnancy test prior to receiving the therapy.
6.Subjects with malignant tumors, who have undergone radiotherapy or chemotherapy within last 2 years.
7.Subjects with type 1 or type 2 Diabetes Mellitus having pre-prandial blood glucose levels >130mg/dL and post prandial blood glucose levels >180 mg/dL at screening visit.
8.Subjects with acute infections, currently on treatment with antibiotics and antimicrobials will not be included. Such subjects may be considered after completion of adequate treatment and as per Investigator’s discretion.
9.Subjects under adrenocorticoid therapy and/or history of alcohol or drug abuse/dependency.
10.Subjects with psychiatric disorders who are considered inappropriate to participate in this study by the Principal Investigator. Subjects with Psychiatric disorders who are on stable medication may be included in the study as per Investigator’s discretion.
11.History of receiving an investigational product within 30 days prior to enrollment in this study.
12.Subjects who are tested positive for HIV, Hepatitis B or Hepatitis C and Syphilis.
13.Subjects who are diagnosed with tuberculosis at the time of Screening.
14.Subjects who have hemoglobinopathies such as and not limited to sickle cell anemia, leukaemia and thalassemia.
15.Subjects who have ongoing history of cardiac, renal and hepatic dysfunctions. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the safety of the Autologous Adult Live Cultured Chondrocytes (CHONDRON®) implantation in articular cartilage defects of the articulating joint(s).  03 months after implantation 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Autologous Adult Live Cultured Chondrocytes (CHONDRON®) implantation in articular cartilage defects of the articulating joint(s).  06 months after implantation 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  
08/04/2015 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a  Prospective, Open-label, Multicentric Study to Assess the Safety and Efficacy of Autologous Adult Live Cultured Chondrocytes (CHONDRON®) in Subjects with Articular Cartilage Defects of the Articulating Joint(s). Subjects will  undergo implantation with CHONDRON® (Autologous Adult Live Cultured Chondrocytes).

The Autologous Adult Live Cultured Chondrocytes (CHONDRON®) implantation is a two stage procedure with Stage I as Biopsy sample collection (cartilage harvest) and Stage II as Implantation (Autologous Adult Live Cultured Chondrocytes implantation). At visit 2, tissue sample of approximately 6-8 mm size will be collected by biopsy from the healthy cartilage of articulating joint(s) under study.

 
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