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).

Phase 3

Completed

• Conditions: Articular Cartilage Defects of the Articulating Joint(s).

• Registration Number: CTRI/2015/04/005661
• Lead Sponsor: Regenerative Medical Services Pvt Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-04
• Last Update Posted: 2016-08-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 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).
• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Centre for Advanced Orthopedic surgery, Krishna Institute of Medical Sciences (KIMS),; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

DeenanthMangeshkar Hospital & Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Kasturba Medical College & Hospital; 🇮🇳 Udupi, KARNATAKA, India

Vardhman Mahavir Medical College & Safdarjung Hospital; 🇮🇳 Delhi, DELHI, India

Centre for Advanced Orthopedic surgery, Krishna Institute of Medical Sciences (KIMS),

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr K Raghuveer Reddy

Principal investigator

9849029934

raghuveer3@rediffmail.com