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
|
|
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)
|
|
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.
|